Find Open Positions
Position Department Location Date
Associate Director, Clinical Operations Clinical Research Cambridge 03/03/2021

POSITION SUMMARY

The Associate Director is accountable for operational planning and execution at the study level with responsibility for clinical study planning and execution (from start-up, conduct, reporting and close out) including timeline, quality and budget). A key focus will be the oversight of and interactions with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission.

The Associate Director will interact with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally important.

The role is primarily responsible for Operational Study Strategy and Study Execution and in addition may have the responsibility of managing 3 or more direct reports. Responsible for directing and managing the internal and external resources and CROs working on ongoing and planned studies. Will manage operational activities required to support Vericel Clinical projects.

ESSENTIAL FUNCTIONS

Responsibilities

  • Primary accountability for operational study-level timeline, cost, and quality deliverables.
  • Lead the development of the clinical study plans including critical path activities and interdependencies for assigned clinical stud(ies).
  • Develop infrastructure to support all trials.
  • Ensure adherence to internal procedures for study planning, study conduct, close out and reporting.
  • Establish study milestones and ensure accurate tracking/reporting of study metrics and timelines
  • Provide strategic input and lead investigator recruitment/selection across projects or programs
  • Proactively assess potential risks to studies and propose mitigation plans.
  • Manage all operational functions contributing to clinical trial execution within and across protocols including project planning, trial budgets, resource management and contract research organization selection and management.
  • Verify the Trial Master File (TMF) is set up and maintained appropriately throughout all studies, including periodic reviews
  • Monitor study budgets against trial progress and bring deviations to the Clinical Executive Management.
  • Review and approve Vendor invoices, including investigator grants and pass through costs, as necessary.
  • Develop working relationships with study investigators, Data Safety Monitoring Board members and Steering Committee members, as required.
  • Ensure study budgets are reconciled with Finance on an ongoing basis.
  • Responsible for the oversight, performance and management of CROs and 3rd party vendors to ensure compliance with Vericel’ s quality measures and adherence to scope of work within timelines and budget at a task level. Specifically, track operational study timelines and monitor operational performance metrics through the life of each study;
  • Responsible for overseeing CRO study start-up activities and coordinating with functional groups to ensure that essential site documents are collected, and sites are initiated per study plan.
  • Develop and/or review materials for submission to FDA and other global regulatory agencies, if necessary.
  • Ensure compliance with CGP, GMP and regulatory guidelines.
  • Review and approve standard operating procedures that impact clinical operations.
  • Mentor junior team members, as appropriate
  • Accountable for ensuring team member compliance with training requirements in the Learning Management System

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Experience

  • At least 2 years of experience in clinical operations management (studies and staff) required
  • 5-12+ years of pharmaceutical /biotech industry experience in areas of clinical trial design, data management, study management, study monitoring, analysis and reporting required
  • Strong interpersonal, management, cross-functional and organizational skills required
  • Practical knowledge of FDA regulations on good clinical practices (GCP) required.
  • Practical knowledge of International Conference on Harmonisation (ICH)-GCP guidelines for clinical trials required.
  • Cell therapy experience desirable.

Education

  • Bachelor's degree in life sciences/related field
  • Advanced degree in a life science highly desirable

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Burn Clinical Specialist - Midwest Commercial Chicago, IL - Homebased 04/14/2021

POSITION SUMMARY

Front line, commercial position responsible for providing support in the procurement of Vericel products and the management of cases from biopsy through surgical procedures and ultimate discharge of burn patients.  Also responsible for providing guidance, support, and input regarding optimal Epicel utilization for care of appropriate burn patients within existing accounts. 

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Provide clinical support for patients receiving Vericel products:
    • Full engagement in and intimate knowledge of the care of Vericel burn patients from admission through discharge
    • Support during various Operating room procedures for each Epicel patient.
  • Awareness of and impact on burn centers’ evolving patient population
  • Knowledge of various burn product utilization protocols
  • Train and support all appropriate staff in active accounts and select prospect accounts
    • All procedures associated with Epicel
    • Supplies compatible and not compatible with Epicel
    • Coordinate & lead surgical skills training programs associated with Epicel
  • Foster development of Key Opinion Leaders (KOLs)
  • Educate key decision makers, including surgeons and support personnel, on Epicel Work in partnership with BTS team

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Basic Qualifications:

  • A professional approach that sees patient welfare as the highest priority, with a strong drive to connect our products and services with every patient who will benefit.
  • 3 to 5+ years of experience with the care of severe burn patients.
  • Experience with hospital operating room environments.
  • Expertise and personality to quickly earn trusted advisor status with key accounts and stakeholders, including top burn experts.
  • Strong clinical and scientific acumen, particularly in burns or wound care, with ability to leverage in training top burn experts and support staff.
  • Ability to thrive in a cross-functional team.
  • Bachelor’s or Master’s degree.  
  • The ideal candidate will be based in the greater Chicagoland area

Preferred Qualifications:

  • Continuous training on technical and product knowledge.
  • Continuous focus on development of personal and interpersonal skills, such as teamwork, time management, listening, trust and integrity, and work/life balance
  • Strategic agility: ability to align individual business strategy with corporate goals, keen business acumen, problem solving, being innovative and thinking big picture.
  • Drive for results: appropriate resource utilization, focus on fundamentals, utilize established best practices, leverage internal support, and take risks.
  • Professional courage: respectfully challenge physicians, embrace difficult conversations, bring solutions, seek feedback, take accountability and ownership of your actions and results.
  • Managing change: adapt to changing business needs, anticipate questions and challenges, deal with ambiguity, be open and transparent with your customers and your team, integrate into your customers’ practice.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Must manage significant regional travel demands

 

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Burn Clinical Specialist - West Commercial Los Angeles, CA - Homebased 04/14/2021

POSITION SUMMARY

Front line, commercial position responsible for providing support in the procurement of Vericel products and the management of cases from biopsy through surgical procedures and ultimate discharge of burn patients.  Also responsible for providing guidance, support, and input regarding optimal Epicel utilization for care of appropriate burn patients within existing accounts. 

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Provide clinical support for patients receiving Vericel products:
    • Full engagement in and intimate knowledge of the care of Vericel burn patients from admission through discharge
    • Support during various Operating room procedures for each Epicel patient.
  • Awareness of and impact on burn centers’ evolving patient population
  • Knowledge of various burn product utilization protocols
  • Train and support all appropriate staff in active accounts and select prospect accounts
    • All procedures associated with Epicel
    • Supplies compatible and not compatible with Epicel
    • Coordinate & lead surgical skills training programs associated with Epicel
  • Foster development of Key Opinion Leaders (KOLs)
  • Educate key decision makers, including surgeons and support personnel, on Epicel Work in partnership with BTS team

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Basic Qualifications:

  • A professional approach that sees patient welfare as the highest priority, with a strong drive to connect our products and services with every patient who will benefit.
  • 3 to 5+ years of experience with the care of severe burn patients.
  • Experience with hospital operating room environments.
  • Expertise and personality to quickly earn trusted advisor status with key accounts and stakeholders, including top burn experts.
  • Strong clinical and scientific acumen, particularly in burns or wound care, with ability to leverage in training top burn experts and support staff.
  • Ability to thrive in a cross-functional team.
  • Bachelor’s or Master’s degree.  
  • The ideal candidate will be based in Los Angeles, Orange County, San Francisco, or Sacramento

Preferred Qualifications:

  • Continuous training on technical and product knowledge.
  • Continuous focus on development of personal and interpersonal skills, such as teamwork, time management, listening, trust and integrity, and work/life balance
  • Strategic agility: ability to align individual business strategy with corporate goals, keen business acumen, problem solving, being innovative and thinking big picture.
  • Drive for results: appropriate resource utilization, focus on fundamentals, utilize established best practices, leverage internal support, and take risks.
  • Professional courage: respectfully challenge physicians, embrace difficult conversations, bring solutions, seek feedback, take accountability and ownership of your actions and results.
  • Managing change: adapt to changing business needs, anticipate questions and challenges, deal with ambiguity, be open and transparent with your customers and your team, integrate into your customers’ practice.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Must manage significant regional travel demands

 

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Director, MACI Manufacturing Manufacturing Cambridge 03/31/2021

POSITION SUMMARY

The Director, MACI Manufacturing is responsible for the leadership, oversight and strategic planning required to support the key business needs of the MACI product line.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Oversight of MACI Cell Therapy Manufacturing.
  • Provide leadership, guidance, and direction to staff consistent with CGMP and company corporate quality governance.
  • Coach and mentor staff in all aspects of their job performance and career development including training, feedback, rewards, and disciplinary action.
  • Provide leadership development of direct staff.
  • Oversee the MACI specific training and qualification program and trainers
  • Maintain and as necessary establish compliant manufacturing policies, procedures, and validation.
  • Track and trend department performance; establish and implement key performance indicators (KPIs).
  • Perform ongoing efficiency assessments and improvements, including staffing, capacity, and productivity.
  • Participate as a cost center manager responsible for forecasting, headcount, project allocation and department spending.
  • Interact with peers in other functional areas to ensure successful manufacturing, testing and release of final products.
  • Ensure process improvements and goals are delivered on schedule and within budget.
  • Collaborate with senior leadership in meeting corporate and site goals.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • Bachelor’s or Master’s degree in biotechnology, biology, biomedical engineering, or equivalent.
  • 10+ years of experience in biologic, cell therapy, or vaccine manufacturing.
  • 6+ years of management experience in an aseptic processing or similar environment.
  • Strong understanding of cell biology and cell culture.
  • Knowledgeable on regulatory requirements and standards affecting Biologics, Medical Devices and Pharmaceuticals.
  • Experience with small scale batch size manufacturing.
  • Comfortable with MS Office suite.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Available for weekend, holiday and after hour coverage.
  • Ability to gown and gain entry to manufacturing areas.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Director, Regulatory Affairs Regulatory Cambridge 03/09/2021

POSITION SUMMARY

The Director, Regulatory Affairs develops regulatory objectives, advice, and strategy in alignment with corporate goals. Plans and manages regulatory document preparation for regulatory submissions to global health agencies. Keeps abreast of evolving regulatory procedures and practices.

ESSENTIAL FUNCTIONS

  • Interact with other departments to develop regulatory strategy and submission plans for quality and timely filings.
  • As a member of study teams, provide regulatory guidance regarding FDA and ex-US regulatory requirements for global clinical development and registration of pharmaceuticals.
  • Oversee preparation, review and submission of regulatory documents maintaining compliance with regulatory requirements.
  • Contribute to identification of issues, gaps and tradeoffs affecting submission and approval.
  • Support and manage preparation of meeting requests and briefing documents.
  • Author/edit documents to support regulatory submissions.
  • Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements.
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
  • Support the organization and record regulatory meetings with health authorities.
  • Provide strategic guidance for and author applications related to designations for expedited programs (e.g. Fast Track, Breakthrough, Priority) or special status (e.g. Orphan).
  • Manage contract staff and vendors as needed to support regulatory activities.
  • Provide create and innovative solutions while being an advocate for compliance.
  • Train and mentor regulatory staff.
  • Assist with SOP generation and contribute to improvements in department best practices.
  • Perform other duties as required, interfacing with other departments, CROs and external vendors as needed.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

LEADERSHIP QUALIFICATIONS:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • 7+ years of experience in Regulatory Affairs strategy for pharmaceutical, biotech, or medical device products in the US market.
  • Three years prior experience managing regulatory affairs professionals
  • Global regulatory experience a plus
  • Regulatory Strategy experience with both development and commercial products.
  • Bachelor of Science in a scientific discipline.
  • Strong knowledge of eCTD elements and structure.
  • Strong regulatory writing skills and use of Microsoft Word.
  • Experience working with all levels of management and consulting with key business stakeholders.
  • Strong team player that has a customer service approach and is solution oriented.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • Possesses strong written and verbal communication.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Executive Assistant General and Administrative Cambridge 03/12/2021

POSITION SUMMARY

The Executive Assistant will report to the Chief Executive Officer and provide high-level administrative support to the Executive Leadership Team. The Executive Assistant will serve as the primary point of contact for internal and external parties on all matters pertaining to Corporate Affairs, and will coordinate Board meetings, serving as a primary resource for the Board. This person will serve as a liaison to the executive team and senior management teams. Will organize and coordinate initiatives for the executive team.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Provide administrative support to the Executive Leadership Team and the Chief Executive Officer using a high level of discretion and confidentiality.
  • Coordinate Board meetings, serving as a primary resource for the Board.
  • Analyze needs and problems, and determine approach and priority in collaboration with senior leaders, their teams and administrative colleagues across functions
  • Prioritize conflicting needs, handling matters expeditiously and proactively. Follow through on projects to successful completion, often with tight timelines.
  • Collect and prepare information for use in executive discussions and meetings.
  • Contact company employees at all organizational levels to gather information and/or prepare reports.
  • Interact internally and/or externally with senior individuals or officers regarding information that may be sensitive or confidential in nature.
  • Coordinate calendars, schedules, meetings, training and travel arrangements for Executive Leadership Team.
  • Prepare expense reports for executive(s) and Board of Director members; manage corporate credit card usage and reconcile charges and submit to Finance.
  • Coordinate and initiate conference calls, Microsoft Teams meetings, and manage all meeting details such as room reservations, preparing agendas, securing necessary IT equipment, catering, and attendee updates.
  • Prepare and distribute presentation materials for internal and external meetings, including board meetings.
  • Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Organize and prioritize information, correspondence and calls for the Executive Leadership Team; draft written responses or reply by phone or e-mail when necessary.
  • Respond to regularly occurring requests for information.
  • Organize and maintain files and records.
  • Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leaderships Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • Bachelor’s degree strongly preferred, or equivalent combination of education and experience may be accepted
  • 10+ years of administrative experience with 5+ years of experience supporting executive level is required
  • Extensive Microsoft Office skills are required, as well as Internet research abilities.
  • Experience with heavy calendar management and national travel scheduling and booking.
  • Strong written and verbal communication skills.
  • Excellent customer service skills required.
  • Project coordination experience and the ability to work well with all levels of internal management and staff, outside clients and vendors required.
  • Ability to exercise sound judgment and confidentiality required.
  • Excellent organizational skills and attention to detail essential.
  • Exercise a high degree of professionalism, diplomacy and discretion in handling confidential information.
  • Ability to work independently and collaboratively with the Executive Leadership Team.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Maintenance Technician II Facilities Cambridge 03/22/2021

Department Description:

Facilities is responsible for the GMP preventive maintenance program, corrective repairs and building upkeep, construction, commissioning, and decommissioning of equipment, and supervising 3rd party contractors who perform maintenance, construction, and cleaning services.

ESSENTIAL FUNCTIONS

Core Responsibilities

  • Perform preventive and corrective maintenance with strict accordance to SOPs.
  • Complete detailed documentation of maintenance work and follow established procedures for GMP document completion, review, and filing / retention.
  • Understand and interpret system documentation including blueprints, sketches, layouts, wiring diagrams, specifications, and operating manuals in performing maintenance and repair activities.
  • Assist in the installation of new equipment and plant systems.
  • Assist in decommissioning of equipment and systems.
  • Participate in cleanroom, laboratory, and office construction projects by cleaning, sanitizing, performing construction work, supervising contractors, moving materials.
  • Perform general facility upkeep including painting, carpentry, plumbing, and electrical work.
  • Respond to urgent work requests regarding employee safety and / or spills.
  • Complete routine building inspection for reliability, environmental, and health and safety factors.
  • Supply information and technical data for procurement of equipment repair parts.
  • Perform light material handling duties.
  • Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • High School Diploma or equivalent.
  • 2+ years of experience with facilities and maintenance.

Preferred Qualifications:

  • Construction experience.
  • Trade school certification.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Work day starts at 7:30 AM.
  • May be required to work in classified and controlled areas such as clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
  • Ability to lift up to 50 lbs.
  • Ability to work outside, including on the roof of the building.
  • Overtime and off shift accessibility is required.
  • Participation in the On Call rotation is required

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Manufacturing Technician Manufacturing Cambridge 06/26/2020

Department Description:

Manufacturing of cell therapy products.

 

Position Summary:

Responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.

 

Core Responsibilities:

  • Perform manufacturing procedures inside an ISO Class 7 clean room in accordance to established SOPs, cGMPs, and safety regulations.
  • Perform aseptic manipulations of cell culture lots and final product assemblies.
  • Document production operations in corresponding batch records and log sheets according to cGMPs and established SOPs.
  • Input data from production records to existing databases.
  • General housekeeping of manufacturing controlled areas.
  • Perform clean room equipment sanitization.
  • Record equipment metrology readings to ensure the equipment operates within specifications.
  • Interact with other departments such as Engineering, Facilities, Materials Management, QA, QC, R&D, Training, and Validation.
  • Review completed production records for accuracy.
  • Work independently under general supervision and direction.
  • Organizational and planning skills and the ability to cooperate with others in a team environment will be critical to success.
  • Practice safe work habits and adhere to Vericel’s safety procedures and guidelines. Other duties as assigned.

 

Leadership Qualifications:

An ongoing commitment to conducting our business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

 

Basic Qualifications:

  • Biotechnology certificate or equivalent with 0-2 years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry, or 3+ years of cGMP experience with GED or equivalent.
  • Excellent communication skills, written and verbal.
  • Organizational and planning skills and the ability to cooperate with others in a team environment.
  • Experience with Microsoft Office.

 

Preferred Qualifications:

  • Experience working in an ISO 7 clean room environment.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • May be required to sit for long periods of time while performing cell culture operations.
  • Must be able to lift, carry, push and pull up to 50 lbs.
  • Ability to work 1 weekend day.
  • Rotating holiday coverage.
  • Ability to gown and gain entry to manufacturing areas.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Manufacturing Training Lead Manufacturing Cambridge 03/22/2021

POSITION SUMMARY

Department Description:

Manufacturing of cell therapy products.

Position Summary:

The Manufacturing Training Lead is for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements. Additionally, this position is responsible for delivering cGMP, technical and organizational development training. This includes training in the areas of general and advanced knowledge of current regulations, functional job knowledge and skill development, compliance and management development in a cGMP environment.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Perform manufacturing procedures inside an ISO Class 7 cleanroom in accordance to established SOPs, cGMPs and safety regulations.
  • Perform aseptic manipulations of cell culture processes.
  • Document production operations in corresponding batch records and log sheets according to cGMPs and established SOPs.
  • Deliver and administer On-The-Job (OJT) training across multiple product lines in accordance with safety guidelines, cGMPs and SOPs.
  • Work with the Manufacturing team to evaluate personnel training needs.
  • Coordinate new hire manufacturing training with Manufacturing Management and the Training Department as required.
  • Schedule personnel for the appropriate qualifications such as Gowning, Aseptic Technique, Personnel Qualifications (PQs).
  • Coordinate training plans with supervisors.
  • Able to understand manufacturing processes allowing for assistance reviewing and revising documents.
  • Assists in deviation investigations, CAPAs, risk assessments and change controls.
  • Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • Bachelor’s degree (Life Sciences or related field) or equivalent with 2+ years of experience in Manufacturing and/or Quality positions, or Biotechnology certificate or equivalent and 4+ years experience.
  • 2+ years of experience working in cGMP
  • Strong experience with PowerPoint, Word and Excel.
  • Ability to work independently under minimal supervision and direction.

Preferred Qualifications:

  • Previous experience developing and delivering training programs.
  • Ability to assist with cross-functional project work.
  • Organizational and planning skills and the ability to cooperate with others in a team environment will be critical to success.
  • Learning Management System experience.
  • Strong written and verbal communication skills.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • May be required to sit for long periods of time while performing cell culture operations.
  • Must be able to lift, carry, push and pull up to 50 lbs.
  • Ability to work 1 weekend day.
  • Rotating holiday coverage.
  • Ability to gown and gain entry to manufacturing areas.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Materials Handler Material Management Cambridge 02/05/2021

Department Description:

Responsible for maintaining an uninterrupted supply of materials for the manufacture of cell therapy products.

Position Summary:

Responsible for the stocking of materials to support the manufacture of commercial cell therapy products meeting internal and regulatory requirements.

Essential Functions:

  • Master core responsibilities of a Materials Technician (Handler).
  • Receive and distribute all Quality Controlled inspected and non-Quality Control inventoried material and general goods received at the Vericel site.
  • Independently perform material receipt and shipment.
  • Execute transactions in Microsoft Dynamics Great Plains (GP) ERP (enterprise resource planning) system independently or with supervision.
  • Maintains inventory control in ERP system by performing system transactions at time of material receipt, storage and distribution.
  • Completes material In-Transit Requests within ERP system for material deliveries from Third Party off-site storage location(s).
  • Assist in preparation of inventory sales order fulfillment process and end of day closing activities.
  • Perform material labeling activities supporting Manufacturing Execution Systems (MES); also referred to as EBR (electronic batch record(s)).
  • Performs routine inventory cycle counts including media.
  • Participates in scheduled annual physical inventory activities.
  • May interact with various groups (e.g., Customer Care, Facilities & Engineering, Finance, Manufacturing, Quality Operations, R&D, and third-party logistics providers (3PL)) on material requests and receipt transactions.
  • Maintenance of material staging area.
  • May assist in providing on the job training to employees.
  • May be assigned on-call responsibility.

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • GED, High school diploma or equivalent with 2 - 5 years of experience working in a cGMP environment in the biotech or pharmaceutical industry or equivalent.
  • Familiarity with MS Office.

Preferred Qualifications:

  • Experience in high volume and fast-paced materials and cleanroom environment.
  • Experience working in warehouse environments.
  • Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies.
  • Excellent communication skills, written and verbal.
  • Other duties as assigned.

Working Conditions and Physical Demands:

  • Ability to gown and gain entry to manufacturing areas.
  • May be required to stand for long periods of time while performing physical duties.
  • Must be able to lift, carry, push and pull up to 50 lbs.
  • Ability to work 1 weekend day.
  • Rotating holiday coverage.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
QA Specialist II Quality Assurance Cambridge 04/09/2021

POSITION SUMMARY

Department Description:

The Quality Assurance department ensures that the site operates at a high level of compliance and ensures quality decisions are being made in accordance with regulatory and site requirements.

Position Summary:

This position is responsible for operational support, including batch record review, media disposition, label issuance and reconciliation, archiving, final product packaging/release to the courier, customer complaint audits, write and/or revise standard operating procedures

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Master core responsibilities of Specialist I.
  • Maintaining and adhering to compliance requirements for established quality systems programs.
  • Identify issues, provide recommendations as well as executing compliance improvements.
  • Participate in mid-scale projects or assignments.
  • Address and/or escalate compliance problems and issues.
  • Interact with project teams and applicable research groups as they impact the quality operation.
  • Product complaints: independently receive, review, audit accompanying patient file, and send to Customer Care.
  • Independently initiate QA deviations and perform investigations, including determining root cause and planning corrective actions.
  • Support the training of specialist I’s.
  • Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • High School Diploma plus 3+ years of related experience in Quality Assurance.
  • Basic knowledge of GMP regulations

Preferred Qualifications:

  • Strong written and verbal communication skills
  • Strong organization and time management skills
  • Experience with Electronic Quality Management Systems (Trackwise)
  • Proficient in MS Word, Excel, and PowerPoint

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Able to lift and transport up to 40 lbs
  • Must work 1 weekend day (Schedule: Tuesday-Saturday)
  • Rotating holiday coverage.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
QC Analyst I Quality Control Cambridge 01/28/2021

POSITION SUMMARY

Department Description:

Quality Control (QC) is responsible for incoming inspection of components and raw materials, plus quality testing (e.g. analytical, microbiological) of intermediate, stability and final product samples to demonstrate that all products manufactured meet standards required for cGMP operations. Various techniques (e.g. assay transfers, validation and qualification of new instrumentation) are utilized within the Quality Control Laboratory to ensure cGMP compliance.

Position Summary:

Perform routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Perform microbiological assays for in-process and final product samples.
  • Perform analytical methods for final bulk material/finished goods.
  • Test and disposition of raw materials and perform environmental monitoring.
  • Review of QC data for compliance to procedures and specifications.
  • Calculate and evaluate results.
  • Participate in lab maintenance and administration duties.
  • Initiate lab investigations and deviations.
  • Lab support including but not limited to glass washing, autoclaving, etc.
  • Effectively demonstrate an understanding of CGMPs and how it applies to specific responsibilities.
  • Follow accurate oral and written procedures for testing of in-process and final product samples.
  • Provide input to the technical composition of operating documentation.
  • Work independently under general supervision and direction.
  • Work in compliance with cGMPs.
  • Practice safe work habits and adheres to Vericel’s safety procedures and guidelines.
  • Maintain lab documentation and notebooks, ensuring timely review, reconciliation and filing.
  • Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • Bachelor’s degree or equivalent education and experience.

Preferred Qualifications:

  • 1 year of experience in a CGMP lab environment.
  • Proficient in Outlook, MS Word, Excel and lab based data management systems.
  • Experience with microbiological testing or environmental monitoring.
  • Experience in a biotech, pharmaceutical or other regulated industry.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Ability to lift 40 lbs.
  • Requires working one day per weekend.
  • Rotating holiday coverage.
  • Rotating off-shift alarm coverage. Must carry a company issued cell phone.
  • May be required to work in classified and controlled areas such as clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
QC Analyst II, Cell Culture Quality Control Cambridge 02/16/2021

Department Description:

Quality Control (QC) is responsible for incoming inspection of components and raw materials, plus quality testing (e.g. analytical, microbiological) of intermediate, stability and final product samples to demonstrate that all products manufactured meet standards required for cGMP operations. Various techniques (e.g. assay transfers, validation and qualification of new instrumentation) are utilized within the Quality Control Laboratory to ensure cGMP compliance.

Position Summary:

Responsible for performing routine and complex testing of in-process samples and final products in accordance with SOPs for product release and validation.

Core Responsibilities:

  • Perform maintenance on complex laboratory equipment.
  • Participate in training of less experienced staff.
  • Participate in transfer methods from support groups to the QC laboratory.
  • May perform finished product review and lot release.
  • Coordinate departmental systems (i.e. inventory, documentation, equipment maintenance)
  • Communicate inter-departmentally and with outside contacts to solve technical issues.
  • Exercise sound judgment and decision making when problem solving.
  • Revise standard operating procedures as needed.
  • Perform deviation and lab investigations as needed.
  • Master core responsibilities of an Analyst I.
  • Other duties as assigned.

Basic Qualifications:

  • Bachelor's degree or equivalent and 2+ years of experience in a lab setting.
  • 2+ years of experience with primary cells and cell culture
  • 1 year of experience in flow cytometry and/or molecular biology

Preferred Qualifications:

  • 1 year of experience in a cGMP lab environment.
  • Proficient in Outlook, MS Word, Excel and lab based data management systems.
  • Experience with microbiological testing, biological assays, or environmental monitoring.
  • Experience in a biotech, pharmaceutical or other regulated industry.
  • Excellent communication skills, verbal and non-verbal desired.
  • Excellent technical writing and investigational skills.
  • Experience with PCR based methodology or cell culture methods.
  • Advanced microbiological techniques, disinfectant efficacy, microbial identification, rapid methods, etc.

Working Conditions and Physical Demands:

  • Ability to lift 40 lbs.
  • Schedule is Sunday - Thursday, 8 AM - 4:30 PM
  • Rotating holiday coverage.
  • Rotating off-shift alarm coverage. Must carry a company issued cell phone.
  • May be required to work in classified and controlled areas such as clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Quality Control Analyst, Senior Quality Control Cambridge 04/09/2021

POSITION SUMMARY

Department Description:

Quality Control (QC) is responsible for incoming inspection of components and raw materials, plus quality testing (e.g. analytical, microbiological) of intermediate, stability and final product samples to demonstrate that all products manufactured meet standards required for cGMP operations. Various techniques (e.g. assay transfers, validation and qualification of new instrumentation) are utilized within the Quality Control Laboratory to ensure cGMP compliance.

Position Summary:

Responsible for performing routine and complex testing of in-process samples and final products in accordance with SOPs for product release and validation.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Perform QC testing in a cGMP lab for raw material release, final product/in process testing and process qualifications
  • Conduct data analysis of testing results, and review data obtained for compliance to SOP and specification.
  • May transfer methodology from other groups and may maintain complex equipment.
  • Author reports, SOPs and other documentation for quality testing.
  • Provide training and technical leadership to less experienced staff.
  • Participate in and/or perform laboratory investigations and non-conformance deviations.
  • Perform finished product review and lot release.
  • Manage departmental projects.
  • Serve as the laboratory point of contact for less experienced staff when management is not present (weekends, holidays)
  • Participate in the execution of corrective and preventative action plans as well as the initiation and follow through for change controls.
  • Author protocols and technical reports related to the implementation of QC equipment.
  • Master core responsibilities of an Analyst II.
  • Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make the company a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • Bachelor's Degree or equivalent and 4 +years of experience in a lab setting.

Preferred Qualifications:

  • Experience as a technical leader in a strong team environment and work independently to successfully balance short and long term project objectives.
  • Experience with Deviation Management and Change Control.
  • Experience with complex analytical methods such as PCR based methodology or cell culture methods.
  • Experience with assay/equipment validations/transfers.
  • Experience with microbiological testing or environmental monitoring.
  • Excellent communication skills, verbal and non-verbal desired.
  • Excellent technical writing and investigational skills.
  • Advanced microbiological techniques, disinfectant efficacy, microbial identification, rapid methods, etc.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Ability to lift 40 lbs.
  • Requires working one day per weekend.
  • Rotating holiday coverage.

 

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Regional Sales Director - West Sales-MACI Los Angeles, CA - Homebased 02/04/2021

POSITION SUMMARY

Lead a Sales Culture of Performance through flawless execution of strategy, tactical plans and key initiatives.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Meet or exceed sales goals and achieve results through teamwork and collaboration.
  • Provide leadership in development of selling strategies.
  • Create a high performing organization through recruiting, training, performance management, coaching and mentoring of team.
  • Maximize time in the field with Cell Therapy Specialists to offer continuous and ongoing coaching and development.
  • Build a network of customer and industry contacts for sales development and marketing partnership.
  • Maintain current knowledge of market and competitive trends.
  • Ensure compliance with policies and procedures.
  • Collaborate and partner effectively with peer and support functions.
  • Organize and execute meetings that yield shared insight and result in actionable next steps.
  • Communicate effectively and positively influence the behavior of others.
  • Trust the actions of team members and assume best of intentions with due diligence to verify results
  • Work closely with Cell Therapy Specialists to plan territory coverage and develop customer targeting strategies. Effectively deploy strategies that maximize human and financial resources.
  • Territory includes all of California and Nevada.
  • Additional responsibilities include: participate in cross-functional strategy sessions, identify market trends through data analysis, proactively work with sales training team to ensure deployment of training to staff, present at Regional and National Sales Meetings, and effectively manage administrative and financial responsibilities

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • Bachelor’s degree in Business or Marketing (preferred)
  • 10+ years of experience in sales in pharmaceutical, biotech or medical device industry.
  • 5+ years of experience directly managing a sales team. Demonstrated career progression within sales, marketing or training. (preferred)
  • Candidate based within 30 miles of Los Angeles County or San Francisco
  • Proven track record of consistently meeting or exceeding goals and/or other quantitative targets and qualitative measures.
  • Proven ability to plan, forecast, and manage financial information.
  • Demonstrated experience in creative problem solving, advising management on sales strategy, and motivating team to achieve concrete goals.
  • Excellent verbal and written communication, strong presentation and training skills.
  • Ability to create meaningful relationships with key opinion leaders.
  • Customer focused approach with includes responding to customer and team with a sense of urgency and professional respect.
  • Strong leader with effective coaching and teambuilding skills.
  • Strong understanding of product, disease state and competition
  • Strong knowledge of managed care and product reimbursement of specialty pharmacy/buy & bill.
  • Superior and persuasive negotiation skills required with the fortitude to sell, compete and be a self-starter.
  • Strong working knowledge of MS Outlook, Word, PowerPoint. Working knowledge of MS Excel including basic formulas and formatting.
  • Valid state driver’s license.

Preferred Qualifications:

  • Knowledge of anatomy and physiology strongly desired in order to understand where and how products work clinically (orthopedic background preferred).
  • Self-motivated, high commitment and dedication with proactive mindset.
  • Detail oriented with strong analytical and problem-solving skills along with the ability to review voluminous amounts of information (e.g. data tables) to distill relevant information.
  • Ability to develop and manage relationships in an effort to meet short and long-term business objectives.
  • Team player with the ability to lead and build consensus and to work on multiple projects simultaneously.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Extensive travel required.
  • Responsible for a large geography.
  • Travel would consist of time spent in field with sales force, attending business meetings, industry meetings and working with key customers.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Scientist II Research and Development Cambridge 03/04/2021

Department Description:

The Research and Development group within Vericel supports the continuing development, characterization and validation of manufacturing methods, novel assays, new technology and operational improvements. This group manages technology transfers, clinical manufacturing, training, database development, trending analysis and stability. The R&D team plays an important role in commercial manufacturing troubleshooting, root cause investigation, process optimization and product life cycle management.

Position Summary:

Applies scientific and/or engineering principles and expertise in the design and development of robust, cost-effective manufacturing procedures and associated analytical method that meet quality, GMP, regulatory and health, safety, and environmental standards.

Core Responsibilities:

  • Demonstrates a comprehensive solid understanding and use of scientific / engineering principles and professional practices, to solve a wide range of complex problems in creative and practical ways.
  • Leads design reviews, cross-functional development teams and provides scientific / engineering support and guidance in the development, scale-up, optimization and operation of methods for the production and testing of new components, technologies and products.
  • Maintains and demonstrates significant knowledge of state-of-the art principles and theories in area of responsibility.
  • Independently reviews existing process and analytical development and production data; designs and conducts necessary experiments; interprets results; recommends changes or additional experiments.
  • Designs, executes, and interprets experiments to identify new methods to enhance the manufacture of or characterization of products in regard to safety, identity, strength, purity, stability and quality with minimal direction.
  • Stay abreast of new developments/technologies in areas of responsibility. Prepares proposals for introduction of technologies outlining the positive impact to the product for cost and/or quality.
  • Participate in establishing project strategy in consultation with management.
  • Represents the corporation in the greater biotech community by publishing in peer review journals and participation in scientific / technical conferences.
  • Represents the organization as the prime technical contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations.
  • Guides the successful completion of major programs and may function in a project leadership role.
  • Directs the work of more junior staff. Provides technical guidance and trains less experienced staff.
  • Other duties as assigned.

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • BS and 9+ years of related work experience, or
  • MS and 7+ years of related work experience, or
  • Ph.D. or equivalent in Biology, Biochemistry, Biomedical, Chemical, or Mechanical Engineering, or related fields and 4+ years of related work experience.
  • Expertise in one or more of the following: Bioengineering, Molecular Biology, Flow Cytometry.
  • Advanced expertise in mammalian cell culture and related techniques.
  • Proficient with technical writing and statistical analysis to produce technical and/or validation protocols and reports.

Preferred Qualifications:

  • 4+ years of experience working on development or support of assays and/or manufacturing processes for a biological drug in a GMP facility.
  • 4+ years of experience in isolation and culturing human primary cells.
  • 4+ years of experience in developing autologous cell therapies or tissue engineered products.
  • Hands-on analytical experience using techniques such as RNA/DNA purification, PCR, qPCR, multi-color flow cytometry, cell counting, and cell-based assays.
  • Experience designing primers and probes for qPCR and gene expression analysis.
  • Advanced expertise in product, process and test method development as well as mechanical design, prototyping, biomaterials.
  • Technical ability to turn design ideas into product/process improvements.
  • Proficient in CAD software, preferably AutoCAD and MATLAB
  • Good leadership and people skills, teamwork experience, and demonstrated conflict handling and resolution ability and negotiation skills.
  • Good achievement and record in scientific research and technical development as evidenced by research paper, conference presentation, and patent publications.
  • Self-motivated, organized, familiar with the relevant literature, attention to details.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Sr. Buyer/Planner Material Management Cambridge 04/20/2021

POSITION SUMMARY

Department Description:

The Materials (Supply Chain) Department and Sr. Buyer/Planner are responsible for ensuring an uninterrupted supply of materials essential for the functioning of assigned product lines and areas.

ESSENTIAL FUNCTIONS

  • Review purchase requisitions to ensure that they meet the organization’s compliance.
  • Create Purchase Orders; maintain accurate open PO lines to define inbound quantities and due dates from suppliers.
  • Managed returned goods to suppliers.
  • Confirm that modifications and changes to existing orders are properly documented and processed.
  • Maintain serialization master data, internal procedures and work instructions.
  • Track status of back orders and inventory aging report.
  • Partner with internal customers when needed to expedite purchase requisitions or identify solutions for supply chain disruptions, which may include the sourcing of alternative providers
  • Resolve pricing and/or invoicing discrepancies with suppliers.
  • Plans the replenishment of materials to support the production schedule, while controlling inventory turns and materials shortages.
  • Conducts material planning and inventory management for assigned raw materials.
  • Maintains accurate data regarding Bill of Materials associated with all raw materials.
  • Act as liaison with suppliers and Vericel finance during annual standard cost updates.
  • Requests quotes from suppliers to perform new supplier sourcing and evaluation.
  • Adheres to appropriate Standard Operating Procedures for business planning unit to ensure compliance with SOPs, ISO 9000, and cGMP procedures, MRB, Sarbanes-Oxley Controls, and corrective action goals.
  • Appropriately escalate any known supply chain disruptions, order discrepancies, or contract matters for internal review and remediation.
  • Create, prepare, and maintain reporting to provide data to monitor trends and allow site business decisions on a timely basis.
  • Establish metrics to monitor supplier performance.
  • Identify and report key performance indicators to measure supplier performance;
  • Achieve company goals and objectives for financial and service level metrics
  • Other job duties are required.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • B.S. degree
  • Experience working on cross functional teams.
  • Strong written and verbal communication skills.
  • 4+ years of relevant work experience within forecasting, demand planning and/or other relevant analytical experience
  • Advanced knowledge of MS Excel and MRP.
  • Strong working knowledge of and experience with ERP systems (Oracle, SAP, etc..)
  • Familiar with Purchasing and Quality Systems.

Preferred Qualifications:

  • Experience in Life Sciences.
  • Familiar with cGMP processes.
  • Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Supervisor, Manufacturing Manufacturing Cambridge 03/09/2021

POSITION SUMMARY

 

Department Description:

Manufacturing of cell therapy products.

 

Position Summary:

The Supervisor, Manufacturing is responsible for oversight of manufacturing activities for cell therapy products meeting internal and regulatory requirements.

 

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Master all Team Lead, Manufacturing core responsibilities.
  • Assist in selection, development, and motivation of qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
  • Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
  • Coach and mentor staff in all aspect of their job performance and career development including training, feedback, rewards and disciplinary action.
  • Work with team and training leads to develop work plans, assign tasks, and supervise team(s).

 

Additional Responsibilities:

  • Supervise staff in the Manufacturing environment.
  • Generate the daily manufacturing schedule and master day sheet.
  • Actively perform and oversee daily cell culture activities to assure compliance with all company and regulatory procedures.
  • Conduct annual performance reviews and provide regular feedback based on goals.
  • Organize the staff and workload to meet or exceed productivity performance standards.
  • Complete corrective action plans to address deficient areas identified and to ensure adherence to compliance.
  • Be available on-call.
  • Serve as manufacturing SME for audit activities (internal & external)

 

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

 

Basic Qualifications:

  • Bachelor’s degree or equivalent and 4+ years of working in GMP environment in the biotech or pharma industry
  • Must possess solid working knowledge of MS Office.
  • Fully trained with manufacturing of one cell therapy product.

Preferred Qualifications:

  • Previous supervisory experience.
  • Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies.
  • Excellent communication skills, written and verbal.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • May be required to sit for long periods of time while performing cell culture operations.
  • Must be able to lift, carry, push and pull up to 50 lbs.
  • Schedule is Sunday - Thursday, 1st shift
  • Rotating holiday coverage.
  • Ability to gown and gain entry to manufacturing areas.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Supervisor, Validation Engineering Cambridge 04/06/2021

POSITION SUMMARY

Department Description:

The Validation department performs equipment, utility, cleaning, sterilization, software, and process validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for cell therapies products.  The department also functions as the liaison with the Metrology department and performs all equipment ownership and quality assurance review responsibilities associated with site calibration activities.

Position Summary:

Responsible for performing validation in a GMP biotech manufacturing facility.

ESSENTIAL FUNCTIONS

Core Responsibilities:

This position requires both individual responsibilities and supervision of validation engineers, including:

  • Manage validation department personnel including performance evaluation, career development, mentoring and coaching
  • Lead Validation group meetings and collecting and monitoring validation group performance metrics
  • Lead complex validation projects, and the validation aspects of multi-departmental projects
  • Ensure timely execution and closure of scheduled requalifications
  • Ensure timely completion of project activities, including development of system lifecycle documentation, risk assessments, qualifications, and reports.
  • Identify and implement improvements to validation systems
  • Supervise the calibration system and Calibration Coordinator to ensure that scheduled and ad hoc calibrations are performed as required
  • Serve as subject matter expert (SME) for facilities, utilities, and equipment commissioning and qualification (C&Q)
  • Train Validation Engineers on validation concepts and techniques
  • Support investigations into failures of qualified systems, leading as appropriate
  • Develop and revise Validation SOPs to maintain the system in a state of compliance and efficient operation
  • Write, review, and approve validation documentation, including protocols and reports
  • Stay current with industry guidance documents and trends impacting Validation
  • Establish and support a culture of compliance, professionalism, and high performance within the Validation group

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services.  This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • Bachelor's Degree or equivalent and 6+ years of validation experience, or
  • Master’s Degree or equivalent and 4+ years of validation experience.
  • 3-4 years of experience with process, equipment, utility, and/or software validation in a GMP regulated environment.

Preferred Qualifications:

  • Proficient with GE Kaye Validator and/or ValProbe data acquisition systems.
  • Working knowledge of GMPs.
  • Excellent technical writing and verbal communication skills.
  • Basic math and statistical skills.
  • Must be people oriented and a team player.
  • Experience with Microsoft Office including Excel, PowerPoint, Word, Project and Visio.
  • Familiarity with temperature chamber, sterilization, cleaning, software and depyrogenation qualifications.
  • Prior experience with troubleshooting, investigating and effectively documenting deviations and discrepancies on project execution.
  • Experience with writing validation protocols, project plans and final reports and managing validation projects.
  • Ability to read/interpret engineering drawings and design documents.
  • Knowledge of risk management tools and techniques.
  • Prior experience supervising personnel.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • May be required to work in classified and controlled areas such as clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
  • Able to lift up to 40 lbs.

 

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now

NASDAQ: VCEL

$53.46 -1.31 (-2.39%)
Day High: $55.21
Day Low: $51.26
Volume: 637188
4:00 PM on
April 20, 2021
Copyright West LLC. Minimum 15 minutes delayed.

Company Presentation