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Clinical Account Specialist - Tulsa, OK Commercial Tulsa, OK - Homebased 01/05/2021

POSITION SUMMARY

Clinical Account Specialist is responsible for MACI sales and Surgeon growth.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Call on orthopedic surgeons and specialists in cartilage repair to deliver a targeted sales message based on accurate clinical information, using approved sales and marketing materials.
  • Attend surgical implantation procedures, as needed, and provide education, training and support to clinical personnel and other staff associated with use and implant of Vericel Products.
  • Ensure completion of Surgeon product training required by FDA.
  • Work with customers to educate on product and procedure reimbursement across different insurance carriers and facilities, and foster a relationship with case management team.
  • Utilize corporate resources i.e. education speaker programs, lunch budgets, and local conference attendance.
  • Knows, understands, and follows Vericel and Government regulations.
  • Territory includes northwest to Bartlesville, east to Rogers and Fayetteville, AK and south to OK/TX border.
  • Other projects and assignments 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 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, with a science, business or marketing degree preferred.
  • 3-5 years of proven successful sales results. OR sales and orthopedic background preferred.
  • Knowledge of anatomy and physiology strongly desired in order to understand where and how products work clinically.
  • Candidate will need to undergo and successfully pass hospital credentialing requirements in order to perform certain aspects of their job, including a 10 panel drug screen.
  • 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) and distill relevant information.
  • Ability to develop and manage relationships 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.
  • Able to demonstrate flexibility, independence, initiative, creativity, confidentiality, integrity, stability and efficiency.
  • Excellent verbal and written communication, strong presentation and training skills, and interpersonal and relationship building skills.
  • Project management skills and proficiency with Microsoft applications.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Travel minimum 90% of the time within territory. Ability to attend surgery and stand for long periods of time.

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 02/05/2021

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
Director, Supply Chain Manufacturing Cambridge 12/17/2020

POSITION SUMMARY

 

Directs all aspects of the organization’s supply chain including but not limited to material planning, purchasing, raw material distribution, staff management and warehousing. Develops departmental objectives and procedures with respect to inventory levels and metrics. Utilizes expertise in field's concepts, practices, and procedures to ensure cGMP compliance and promote constant improvement. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. Leads and directs the work of others.

ESSENTIAL FUNCTIONS

 

Core Responsibilities:

  • Oversight of the Material departments (Materials Management and Material Handling) with emphasis on colleague development.
  • Manage operating budget and allocate resources to optimize business results.
  • Direct activities related to controlled materials: material selection, purchase and inventory control, shipping/receiving and materials storage.
  • Ensure supply chain continuity to meet company requirements while maintaining acceptable inventory levels.
  • Subject matter expert for organization’s ERP system with respect to Item Data, Purchasing, Inventory Control, and Bills of Materials.
  • Negotiate pricing and maintain standard cost data for the organization.
  • Lead relationships with suppliers, including 3PLs, CMOs, and wholesalers.
  • Collaborate with legal to review and implement supply agreements with key suppliers.
  • Provide leadership of cross-functional projects and teams to ensure successful completion on schedule and within budget.

 

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 production operations management or related field.
  • Supply Chain Management certification(s) (e.g., CSCP, CPIM, SCOR-P, CPM, etc.).
  • Minimum of 15 years practical experience in Materials Planning and Purchasing.
  • Minimum of 10 years supervisory experience.
  • Demonstrated record of career progression within field.
  • Expertise with budget, forecasting and materials management.
  • Experience working in a CGMP/FDA regulated environment.
  • Demonstrated expertise with ERP systems, 3PL and CMO oversight.
  • Experience with serialization, including global requirements.
  • Highly effective and professional communication skills with employees and supplier representatives at all levels.
  • Established track record of mentoring and developing staff and building high performing teams.

 

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Must be able to lift, carry, push and pull up to 50 lbs.
  • On call for weekend and 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
Maintenance Technician II Facilities Cambridge 02/24/2021

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
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
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 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:

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 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.

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 2+ years of experience in a lab setting.

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.
  • 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
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
Regional Sales Director, Burn Team - East Sales-Epicel New York, NY - Homebased 11/02/2020

POSITION SUMMARY

 

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

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Support an environment that best allows Account Managers (AM) to succeed, including focusing on the welfare of our stakeholders and the patients they serve.
  • 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 Account Managers to offer continuous and ongoing coaching and development.
  • Partner with Account Managers and Burn Clinical Specialists to optimize management of all Epicel cases; must have ability to manage a case independently.
  • 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 Account Managers to plan territory coverage and develop customer targeting strategies. Effectively deploy strategies that maximize human and financial resources.
  • Foster appropriate coordination between the AMs and the Burn Clinical Specialists (BSC)
  • 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 in a complex selling environment. Demonstrated career progression within sales, marketing or training. (preferred)
  • Candidate based within 30 miles of Boston, MA; New York City, NY or Philadelphia, PA. Will also consider candidates based within 30 miles of Atlanta, GA or Chicago, IL.
  • 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 (burn 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
Regional Sales Director, Burn Team - West Sales-Epicel Los Angeles, CA - Homebased 11/02/2020

POSITION SUMMARY

 

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

ESSENTIAL FUNCTIONS

 

Core Responsibilities:

  • Support an environment that best allows Account Managers (AM) to succeed, including focusing on the welfare of our stakeholders and the patients they serve.
  • 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 Account Managers to offer continuous and ongoing coaching and development.
  • Partner with Account Managers and Burn Clinical Specialists to optimize management of all Epicel cases; must have ability to manage a case independently.
  • 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 Account Managers to plan territory coverage and develop customer targeting strategies. Effectively deploy strategies that maximize human and financial resources.
  • Foster appropriate coordination between the AMs and the Burn Clinical Specialists (BSC)
  • 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 in a complex selling environment. Demonstrated career progression within sales, marketing or training. (preferred)
  • Candidate based within 30 miles of Los Angeles, Orange County, or San Francisco, CA. Will also consider candidates based within 30 miles of Denver, CO or Dallas, TX.
  • 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 (burn 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
Revenue and Accounts Receivable Accountant Finance and Accounting Ann Arbor 12/21/2020

POSITION SUMMARY

This position will serve as an integral part of the Revenue function. It will work closely with the Accounts Receivable department on daily invoicing, deposit posting and maintain customer account master data and report to the Senior Manager of Technical Accounting on revenue recognition items. The person in this position must have knowledge of general accounting, including debits and credits, general ledger knowledge and preferred experience in revenue.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Verify and post details of business transactions, such as funds received, and totals accounting, using calculator and computer.
  • Type and print vouchers, invoices, account statements, reports, and other records using computer
  • Perform detailed cash receipt analysis to ensure insurance reimbursements received are appropriately applied against accounts receivable and other GL accounts.
  • Post accounts receivable cash receipts and prepare appropriate adjustments with supporting documentation.
  • Maintain customer account master data.
  • Maintain customer relations, customer sales invoice files, and implement special invoicing
  • Generate, print, and mail invoices to be paid by customers.
  • Investigate and problem solve short pay invoices with internal departments and customers.
  • Ensure documentation/support created of all work performed is clear, concise, and in adherence with internal control procedures.
  • Provide assistance on all internal and external audit requests timely & effectively
  • Reconcile miscellaneous accounts.
  • Book miscellaneous journal entries.
  • 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 in accounting, finance or related area required.
  • 3+ years of accounting experience
  • Intermediate Excel skills needed to perform majority of role functions
  • Working knowledge of Microsoft Office.
  • Ability to perform accurate data entry
  • Ability to use the internet to source information.
  • Detail oriented and organized
  • Strong problem solving and analytical skills
  • Self-motivated
  • Effective at multi-tasking and meeting constant stream of deadlines
  • Clear and concise written and verbal communication skills
  • Ability to work both independently and collaboratively with external and internal peers

Preferred Qualifications:

  • Experience in accounts receivable management including billing, pricing, credit assessment, cash application, and collections is a plus.
  • Working experience with Microsoft Dynamics Great Plains strongly preferred

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 12/22/2020

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 02/23/2021

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 02/01/2021

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

NASDAQ: VCEL

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February 24, 2021
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