Director, Clinical Development |
Clinical Research |
Cambridge |
POSITION SUMMARY
The Director of Clinical Development will provide direction on clinical plans, contribute to clinical deliverables including clinical study conduct and oversight, study reports, scientific abstracts and manuscripts, and regulatory submissions in support of Vericel clinical development and scientific reporting.
The Director will also provide scientific and GCP oversight of clinical operations outsourced to CROs.
ESSENTIAL FUNCTIONS
Core Responsibilities
- Provide scientific expertise to develop and oversee clinical projects including registration and non-registration studies
- Provide strategic input as well as development support for clinical program plans and study protocols
- Responsible for drafting and finalizing clinical study protocols and amendments
- Responsible for drafting, review, and finalization of statistical analysis plans in collaboration with biostatistician
- Responsible for authorship of clinical sections of regulatory submissions
- Responsible for the development and maintenance of clinical SOPs
- Perform data content and study document reviews (e.g., blinded data reviews, review of exploratory and final analyses, review of draft reports and regulatory documents)
- Provide scientific training for Clinical Operations and CRO personnel associated with study execution
- Participate in the preparation and review of scientific meeting abstracts, presentations, and manuscripts
- Represent company to external parties such as business partners, contract medical writers, contract biostatisticians, expert consultants, investigators, and the scientific community
- May participate in the selection and oversight of vendors
QUALIFICATIONS, EDUCATION AND EXPERIENCE
Basic Qualifications:
- MS with 10+ years of experience working in pharmaceutical/biotech industry clinical development
- Broad understanding of clinical development and US pharmaceutical regulatory requirements
- Previous contributions to IND/BLA/NDA regulatory submissions (writing and review)
- Able to develop innovative/creative solutions to complex problems
- Able to manage several projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change
- Excellent interpersonal and communication skills including demonstrated success in working on cross-functional teams in a highly matrixed environment.
- Able to manage staff
Preferred Education and Experience:
- PhD or equivalent in Biology, Biochemistry, Pharmacology, Epidemiology, or related fields IND/BLA/NDA writing or defense experience
- Clinical development experience with autologous cell therapy
- Translational medicine experience
- Demonstrated success in manuscript writing/authorship
- Past interaction with FDA and other regulatory agencies
WORKING CONDITIONS AND PHYSICAL DEMANDS
- Travel to attend professional development conferences or to visit research collaborators/investigators
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
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Engineer II |
Engineering |
Cambridge |
POSITION SUMMARY
Department Description:
The Engineering department is primarily responsible for the detailed design, startup, troubleshooting, commissioning, optimization and lifecycle support of manufacturing equipment, facilities, and utility systems.
ESSENTIAL FUNCTIONS
Core Responsibilities:
- Lead Engineering specification, estimating, design, procurement, programming, installation management, startup, commissioning, and documentation of new systems and the ongoing support of existing systems.
- Provide cost estimates for new systems and equipment, and modifications or upgrades to existing systems.
- Lead design reviews, construction projects and installation support.
- Perform engineering startup, factory acceptance testing, commissioning, documentation, validation support and operator training.
- Provide day to day engineering support for process equipment such as Biosafety Cabinets, Freezers, Incubators, Autoclaves, Heat Sealers, etc.
- Provide day to day engineering support for plant equipment such as RODI Water Systems, Vacuum Pumps, Air Compressors, HEPA Filtration, HVAC, etc.
- Create and edit SOPs and Quality System Records based on understanding of GMP Facility systems and Engineering Standards.
- Create engineering Reports and Protocols.
- Provide support for BMS controls, industrial process instrumentation and PLC control.
- Develop and maintain corporate engineering specifications, drawings and standards.
- 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.
Basic Qualifications:
- Bachelor's degree in Mechanical, Chemical or Biomedical Engineering or equivalent engineering field or technical science and 2 or more years of relevant experience.
- Experience with installing, servicing and maintaining equipment in cleanroom environments.
- Experience with MS Office: Outlook, Word, Excel, PowerPoint.
- Experience in writing and editing Technical Reports and Protocols.
- Experience with Quality Systems.
Preferred Qualifications:
- Proficient in CAD software, preferably AutoCAD.
- Exhibits strong communication stills and the ability to work in a cross-functional team environment.
- The ability to react to changing priorities based on manufacturing or business needs.
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.
- Required to work with hand tools.
- Work includes some lifting, up to 50 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
|
Engineer II, Validation |
Quality Assurance |
Cambridge |
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 projects in a GMP biotech manufacturing facility.
ESSENTIAL FUNCTIONS
Core Responsibilities:
- Master core responsibilities of an Engineer, Validation, I.
- Develop and publish new validation project plans and protocols, execute protocols and write final reports with little to no supervision.
- Participate in equipment failure investigations, corrective/preventive actions and equipment release. Provide final approval for equipment release.
- Provide technical assistance to less experienced technicians/specialists.
- Routine and effective communication with immediate supervisor and other personnel within the group in addition to outside the department.
- Review and approve validation and calibration documentation.
- 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 4+ years of validation experience.
- Master’s Degree or equivalent and 2+ years of validation experience.
- 3+ years of experienced 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.
- Knowledge of international regulatory requirements.
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.
- May be required to lift, push or pull 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
|
Human Resources Director |
Human Resources |
Cambridge |
Vericel Corporation has an exciting new opportunity for a high performing Director of Human Resources. Reporting to the Vice President of Human Resources, the Director will serve as a strategic business partner and HR advisor to managers and colleagues located in our Cambridge MA facilities.
Key responsibilities:
Cultivate cross-functional collaborative relationships and offer support and guidance to employees and managers throughout the Cambridge MA facilities
In partnership with functional senior leaders and members of the Executive Leadership Team, identify and implement strategic solutions to support corporate objectives and priorities
Serve as the site HR Business Partner and point of contact for employee relations needs, including providing guidance to leaders in the application of federal and state employment laws, corporate policy, problem resolution, employee development, or other employment matters
Lead the Company’s Diversity, Equity and Inclusion programs and initiatives in partnership with senior leadership
Oversee Affirmative Action Plan compliance and support management training and education
Manage the Company’s talent acquisition function and support the hiring and onboarding activities throughout the organization, guiding our programs for process efficiency, legal compliance, and effective communication. Participate in search activities as needed.
Develop, interpret, and/or communicate HR policies, programs, and best practices in compliance with federal and state laws and in support of the Company’s strategic goals and priorities
Partner with senior leadership to strengthen organization resiliency through succession planning and driving leadership development opportunities. Implement, own, and ensure robust leadership development through combination of formal and/or informal leadership development initiatives to ensure strong leadership presence throughout all functions across the organization
Manage HR-sponsored training and development programs. Collaborate with Training and Talent Acquisition teams to ensure comprehensive new hire orientation and successful onboarding initiatives
Offer performance management guidance and support with respect to employee development conversations and opportunities to maximize or enhance overall performance
Oversee the planning and coordination of employee engagement activities and programs
Facilitate HR-sponsored employee meetings and oversee other sitewide HR employee engagement and appreciation events and activities
Collaborate with HR leadership and legal counsel to manage the administration of Employment Agreements and other Vericel employment documents
Maintain optimized communication, support and collaboration among HR team members and key HR business partners
Qualifications and Education Requirements
Minimum Bachelor’s Degree, preferably in Business Administration, Human Resource Management, or Organizational Development
Master’s Degree preferred
PHR or SHRM certification preferred, with expertise as a well-rounded generalist
Thorough knowledge of federal and state employment laws
Experience developing and writing complex documents or HR policies
Strong analytical and problem-solving skills
Minimum 10 years of progressively more responsible experience in Human Resources, with at least 3-5 years of experience in a senior HR leadership role.
Strong presentation skills; solid verbal and written communication skills; with excellent attention to detail.
Proactive, independent while working in a highly collaborative team environment
Demonstrated ethical leader with high integrity
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
|
Joint Restoration Territory Manager, Arlington, VA |
Sales-MACI |
Arlington, VA - Homebased |
Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Sales professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Director, Regional Sales at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.
POSITION SUMMARY
Joint Restoration Territory Manager 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.
- Other projects and assignments as needed.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
Leadership Qualifications:
An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery 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.
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.
- Ideal candidate will live in the Arlington, VA area.
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
|
Manager, Advocacy Development |
Marketing |
Cambridge |
Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Director, Advocacy Development at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.
POSITION SUMMARY
The Manager, Advocacy Development will be responsible for identifying educational needs and thought leader engagement strategy among the physician community for clinical conditions specific to the portfolio of Vericel solutions. He/she will source educational content and develop venues for knowledge-sharing. He/she will act as a primary conduit to clinician advocates and educators on behalf of Vericel in three key areas: 1) KOL relationship development and alignment; 2) speaker identification and management and 3) program facilitation and execution. This role reports to the Director, Advocacy Development.
ESSENTIAL FUNCTIONS
Relationship management:
- Identify, cultivate and engage healthcare professionals with expertise in specific clinical conditions
- Source educational content
- Nurture relationships with and develop utilization plans for key opinion leaders
- Facilitate a recurring advisory board of healthcare professionals
- Speaker bureau management and speaker training
- Work with Marketing, Sales leadership, and contracted speakers/consultants to gain feedback in support of the evolution of promotional programming content
- Support internal colleagues & field-based members of the commercial team
- Guide the contribution of agency partners
Strategy development:
- Identify and prioritize gaps in knowledge among healthcare professionals in specific clinical conditions
- Curate presentation content for educational & promotional events
- Attend and aid in the coordination of conferences and scientific meetings as identified and directed
- Collaborate with cross-functional colleagues to enhance advocacy of Vericel portfolio
- Contribute to the allocation and management of budget expenses
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:
Experience collaborating with health care professionals in order to develop clinical educational programs.
- Bachelor’s degree (Advanced degree in healthcare, education -related field is preferred)
- Minimum of 3 years’ experience in the healthcare and/or life sciences field
- Strong interpersonal & relationship -building skills
- Demonstrable success managing projects
- Excellent communication & organizational skills
- Strategic, passionate, self-starter who takes initiative
- Availability to travel
- Responsibilities may require a work schedule that may include working outside of “normal” work hours in order to meet business demands
- Proficient in Microsoft Office
WORKING CONDITIONS AND PHYSICAL 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
|
Nexobrid Account Manager - Southeast |
Sales-Burn Care |
Atlanta, GA - Homebased |
POSITION SUMMARY
Front line, account management position with anticipated responsibilities that include supporting the launch and sales of NexoBrid®, a registration-stage biological orphan product designed for the debridement of severe thermal burns. NexoBrid is not yet approved for use or sale in the United States. The FDA has accepted for review a Biologics License Application seeking NexoBrid’s approval and established a Prescription Drug User Fee Act Date for completing that review of January 1, 2023. Following NexoBrid’s approval, anticipated activities include but are not limited to, calling on targeted Burn Centers to develop HCP interest, utilization protocols and advocacy, providing product inservicing, education, and training as well as general account management, including the coordination of Vericel resources to achieve commercialization objectives. Position will eventually include responsibilities with respect to other Vericel branded products (Epicel) in the Burn Care space.
ESSENTIAL FUNCTIONS
Anticipated Core Responsibilities:
Direct sales calls to key decision makers at targeted burn centers, including burn center directors and support personnel, to engage in the sales process:
- Connecting with key stakeholders to the point of earning “trusted advisor status”
- Investigating current patient management practices at targeted accounts specific to the care of patients with severe burns to identify opportunities and specific areas where the appropriate use of NexoBrid may benefit patients
- Being capable of assertively and credibly managing product objections and misconceptions
- Advancing the key stakeholders to action, including their development of appropriate utilization and patient management protocols
Manage territory for optimal performance and effectiveness
- Creating and executing territory business plans that prioritize efforts and resources appropriately.
- Maintaining up-to-date records of each account and stakeholders within CRM tool
- Attending conferences where presence offers territorial value
- Attending procedures where NexoBrid is being used to provide education and guidance on appropriate product use including patient preparation, product application and post operative care
- Expertly leverage promotional materials to effectively tell the NexoBrid and Vericel story in a manner that inspires action
- Partner with Burn Clinical Specialist (BSC) colleagues to supplement educational and clinical support at key accounts in accordance with leaderships guidance
Develop and manage complex accounts via:
- Identifying and connecting with key stakeholders & support staff (account mapping)
- Maintaining complete awareness of evolving patient population and advocating for appropriate product utilization
- Maintaining awareness of competitive activities and threats
- Coordinating use of extended Vericel resources to optimize product utilization and patient care with all Vericel branded products.
Foster access to and procurement of Vericel products:
- Presenting to VAC and P&T committees when required
- Determining procurement process at each targeted account
- Ensuring product economics understanding for NexoBrid at the highest levels in key account
QUALIFICATIONS, EDUCATION AND EXPERIENCE
Basic Qualifications:
- 3 to 5+ years of relevant experience of hospital-based specialty healthcare surgical product sales, with a track record of meeting or exceeding sales goals.
- Experience with hospital operating room environments.
- Strong background in territory and complex account management with an assertive approach
- Strong clinical, scientific and business acumen, particularly in burns or wound care.
- Ability to thrive in a cross-functional team and work effectively in the “team” environment
- A professional approach that sees patient care as the highest priority, with a strong drive to connect our products and services with every on-label patient who will benefit.
- Understanding of medical reimbursement (billing, coding, coverage, and payment) in the healthcare system.
- Bachelor’s or Master’s degree in a health-science field, business, marketing or communications preferred. Experience with burns or burn nursing a significant plus.
- Ideal Location: Atlanta, GA
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, and leverage internal support
- 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 travel demands, including occasional weekend days
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, Materials Support |
Material Management |
Cambridge |
POSITION SUMMARY
Department Description:
Materials support for manufacturing of cell therapy products. Receipt of all components, raw materials, and consumables to be used by production. Inventory management and restocking.
Position Summary:
The Supervisor, Materials is responsible for oversight of all material resupply activities to support site production. This is a cGMP position.
ESSENTIAL FUNCTIONS
Core Responsibilities:
- Master all Materials Team Lead 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).
- Assist Supply Chain Management with 3PL oversight and associated material transfer.
Additional Responsibilities:
- Supervise staff in Materials (e.g., Material Handlers). This group is also referenced as Manufacturing Support.
- Generate the daily inventory support schedule.
- Actively perform and oversee daily receipt and delivery to manufacturing.
- Assure staff 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 or have a trained and qualified designee.
- Serve as 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.
Basic Qualifications:
- Bachelor’s Degree (Life Sciences or related field) with 3+ years, or Associate’s degree with 5+ years, or GED or equivalent with 8+ years of experience working in a cGMP environment in the biotech or pharmaceutical industry or equivalent. Must possess solid working knowledge of MS Office.
- Experience with inventory control, material receipt, and material transfer.
Preferred Qualifications:
- Experience in high volume and fast-paced materials and cleanroom environment. Experience working in warehouse environments.
- 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
- 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.
- Rotating holiday coverage.
- Ability to work 1 weekend day as needed
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
|
Technician, Cell Therapy Manufacturing |
Manufacturing |
Cambridge |
POSITION SUMMARY
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.
ESSENTIAL FUNCTIONS
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.
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:
- 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 cleanroom 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
|
Territory Development Representative, Midwest |
Sales-MACI |
Kansas City- Homebased |
POSITION SUMMARY
Territory Development Representative is responsible for MACI sales and sales support.
ESSENTIAL FUNCTIONS
Core Responsibilities:
- Develop a deep understanding of MACI, knee anatomy, cartilage physiology, cartilage injuries as well as concomitant pathologies that typically accompany patients with cartilage disease. The deep understanding to include the full spectrum of cartilage repair techniques, products and other related knee procedures through company training, self-education as well as business support selling activities
- Support / proctorship of MACI surgical cases, including biopsies and implants
- Provide customer in-services and training to surgeons, including fellows, residents, and support staff (nursing, PAs, etc.)
- Coordinating surgical and training instrumentation transport, delivery and inventory logistics
- Support sales representative by generating new sales opportunities and maintain existing business and relationships.
- Explore and engage in selling opportunities by building relationships and rapport with key clinical staff
- Take ownership of professional development and proactively engage with Field Sales Trainers and other resources to enhance technical, clinical and sales competencies
- Work as team player to ensure quarterly and annual targets are achieved.
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.
Basic Qualifications:
- Bachelor’s Degree, with a science, business or marketing degree preferred.
- 1 year of documented B2B experience in sales, with experience in surgery /medical device applications 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 full immunization and 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.
- Willingness and ability to relocate within the territory or region in order to accommodate business need when an open territory does become available.
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
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Territory Development Representative, New England |
Sales-MACI |
MA/NH/VT/ME - Homebased |
POSITION SUMMARY
Territory Development Representative is responsible for MACI sales and sales support.
ESSENTIAL FUNCTIONS
Core Responsibilities:
- Develop a deep understanding of MACI, knee anatomy, cartilage physiology, cartilage injuries as well as concomitant pathologies that typically accompany patients with cartilage disease. The deep understanding to include the full spectrum of cartilage repair techniques, products and other related knee procedures through company training, self-education as well as business support selling activities
- Support / proctorship of MACI surgical cases, including biopsies and implants
- Provide customer in-services and training to surgeons, including fellows, residents, and support staff (nursing, PAs, etc.)
- Coordinating surgical and training instrumentation transport, delivery and inventory logistics
- Support sales representative by generating new sales opportunities and maintain existing business and relationships.
- Explore and engage in selling opportunities by building relationships and rapport with key clinical staff
- Take ownership of professional development and proactively engage with Field Sales Trainers and other resources to enhance technical, clinical and sales competencies
- Work as team player to ensure quarterly and annual targets are achieved.
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.
Basic Qualifications:
- Bachelor’s Degree, with a science, business or marketing degree preferred.
- 1 year of documented B2B experience in sales, with experience in surgery /medical device applications 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 full immunization and 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.
- Willingness and ability to relocate within the territory or region in order to accommodate business need when an open territory does become available.
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
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