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Associate Director, Engineering 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:

Staff Management:

  • Select, develop, and motivate 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 aspects of their job performance and career development including training, feedback, rewards and disciplinary action.
  • Develop work plans, assign tasks, and supervise team(s).
  • Ensure staff has appropriate knowledge of department processes and procedures.

Budget:

  • Provide input into the department budget.

Department Management:

  • Establish and report applicable department or organizational metrics.
  • Accountable for project completions and achievement of compliance goals.
  • Represent department in project team meetings.
  • Interact with project teams and cross-functional groups.
  • Address and/or escalate site compliance problems and issues.
  • Lead and facilitate meetings/workshops.
  • Develop and implement site-wide and departmental performance goals. Provide regular reports on progress towards completion
  • Represent the company in interactions with external contractors and consultants.

Additional Responsibilities:

  • Partner with other functional areas to effectively schedule maintenance activities, coordinate resources and assign work to direct reports.
  • Work in a collaborative team environment and interact with other support groups such as Validation, Quality Assurance, Metrology and Scientific groups.
  • Ensure schedule adherence and proper prioritization of workload.
  • Put in place robust operations and maintenance strategy, spare parts inventory and assess areas for continuous improvement.
  • Mentor and develop junior Engineers
  • Manage all Engineering projects, ensuring timelines are met
  • Represent the Engineering and group during audits
  • Design and implement upgrades to facilities and equipment in order to meet Vericel corporate objectives, and production targets

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 Engineering, or similar field.
  • A minimum of 5 years of progressively responsible Management experience in a bio-technology manufacturing environment.
  • Knowledge of cGMP, FDA and other pharmaceutical regulatory requirements.
  • Strong documentation skills of maintenance records in a cGMP environment.
  • Microsoft Office Suite computer systems skills with experience in a computerized maintenance management system.
  • A proven track record of establishing and maintaining cooperative working relationships with internal customers, vendors, and direct reports.
  • Must possess comprehensive knowledge of building infrastructure and utility systems.
  • Experience in managing and coordinating multiple service contractors during system shutdowns.
  • Experience in issuing: hot work permits, confined space permits, ceiling entry permits, equipment release forms, action notifications.
  • Experience in prioritizing scheduled work orders and emergency work requests in a 24/7 bio-technology manufacturing facility.
  • Experience in cGMP record review and regulatory audit participation.

Preferred Qualifications:

  • Prior military or maritime academy experience.
  • Construction management experience.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Off shift accessibility is required.
  • Job requires physical work, including lifting
  • Job requires gowning for access to cleanroom 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
Associate Director, Operational Analytics and Performance Engineering Cambridge

POSITION SUMMARY

Provide senior level analytical support and implement performance monitoring initiatives within the broader Operations organization (Manufacturing, Supply Chain, and Quality Operations). Reporting to the Chief Operating Officer, this highly visible role supports the Operations organizations as a KPI owner with oversight and accountability for adjustments and data analysis/simulations to optimize decision making related to Products, Cost, and Process. This role is also responsible to support the extended Operations leadership with Budget and Forecasting cycles as well as working cross functionally with the Finance team.

ESSENTIAL FUNCTIONS

  • Supports budget and forecasting cycles by liaising between Operations leadership and the Finance team.
  • Perform qualitative and quantitative analysis for various Operational areas.
  • Lead functional efforts to translate and communicate detailed information for executives, Finance and Operations.  Including reporting KPIs and other senior level reports on a monthly/quarterly/annual basis.
  • Accountable for the weekly review of financial performance to plan, engaging with Subject Matter Experts for root-cause analysis and mitigation plans.
  • Strong collaboration with IT for system error corrections, new systems, upgrades, and process improvements.
  • Provide information to leadership team on functional performance along with recommendations for corrective/remedial action plans to anticipate risks and enable decision-making
  • Leads the efforts to identify and develop systems and processes to monitor and understand operational efficiencies including material inventory levels, material utilization, scrap, purchasing habits, inventory turnover, and other direct costs involved in product manufacture.
  • Provide key liaison role between Operations and Finance including communicating key metrics and trends, developing tools that utilize ERP data, and leading teams to achieve cost efficiency goals.
  • Act as a subject matter expert for the site for direct cost contributors to COGS including raw material utilization, scrap, and labor balance between manufacturing activities.
  • Provide site support for establishing manufacturing site transition and cost containment plans as company expands into a new manufacturing facility.
  • Accountable for the weekly review of financial performance to plan, engaging with Subject Matter Experts for root-cause analysis and mitigation plans

Partner with site leadership team, Chief Operating Officer, and Finance team to measure and improve productivity and cost effectiveness of operational processes and systems.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership qualifications include, among other requirements:

  • Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
  • 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.
  • Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • Bachelor’s degree required, MBA preferred
  • Management and Leadership experience in the Biotechnology industry
  • Budgeting & Cost Variance management
  • Excellent communication skills including
    • Ability to effectively communicate persuasively across the corporation,
    • Communicate effectively with senior management, and
    • Advanced skills in PowerPoint, ERP systems experience, experience with visualization/BI tools, scripting, data modeling and scenario planning
  • Proven analytical, planning, and problem-solving skills
  • Solid initiative, driven self-starter; able to work independently and manage results
  • Strong partnering and interpersonal relationship skills
  • cGMP knowledge

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 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.
  • 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 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
IT Compliance Lead Information Technology Cambridge

POSITION SUMMARY
Accountable for delivering validation knowledge leadership for IT projects by creating computerized systems life cycle documentation, creating and revising IT standard operating procedures and deploying technology solutions to ease the administrative burden in a compliant manner.

ESSENTIAL FUNCTIONS

  • Develop solutions (knowledge base, artifacts, technology) to address IT Quality Compliance needs.
  • Deliver agility to the organization by streamlining IT Change Management and CSV processes.
  • Draft Computer Systems Validation and IT Change Management SOPs to align with GAMP 5 and industry standards.
  • Author, review and update validation documents as necessary for GxP IT implementation projects.
  • Provide Delivery Support to multiple ongoing IT initiatives.
  • Evaluate business requirements and provide solutions based on need.
  • Provide expertise in the areas of IT Quality & Compliance, Computer Systems Validation, Quality assessments, ISO 13485 regulations, 21 CFR Part 11, Annex 11, GxP requirements, Quality System Regulations, CAPA processes, Quality Management Systems design, Supply chain management, process validation and Quality system validation for regulated Life Science environments.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Basic Qualifications:

  • MUST have Pharmaceutical, Bio-Technology, or Life Science industry experience
  • 7+ years of experience in Computer System Validation in a cGMP manufacturing environment.
  • Knowledge of GMPs, GAMP 5, 21 CFR Part 11, Annex 11, MHRA/FDA Data 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
Materials Associate Material Management Cambridge

POSITION SUMMARY

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.
  • Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leaderships Qualifications:

Leadership qualifications include, among other requirements:

  • Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
  • 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.
  • Serving as role models for our fellow employees and business partners 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.

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
Nexobrid Account Manager - Atlanta 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
Nexobrid Account Manager - Metro New York Sales-Burn Care New York, NY - 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: Metro NYC

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
Nexobrid Account Manager - Northern CA Sales-Burn Care San Francisco - 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: Northern CA / Pacific Northwest

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
Nexobrid Account Manager - Ohio Sales-Burn Care Columbus, OH - 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: Columbus or Cincinnati OH

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
Nexobrid Account Manager - St. Louis Sales-Burn Care St. Louis, MO - 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: St. Louis, MO

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
Nexobrid Account Manager - Virginia Sales-Burn Care Richmond, VA- 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: Richmond, VA to Baltimore, MD

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
QC Analyst I Quality Control Cambridge

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.

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

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 Quality Control 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 Senior Manager, QC Microbiology 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.

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 current Good Manufacturing Practices (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 microbiological assays for in-process and final product samples.
  • Perform analytical methods for final bulk material/finished goods.
  • 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 a QC Analyst I.
  • Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leaderships Qualifications:

Leadership qualifications include, among other requirements:

  • Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
  • 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.
  • Serving as role models for our fellow employees and business partners 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 3+ years, MS with 0-1+ years of experience in a lab setting.
  • 2+ years of experience in one or more of the following disciplines: microbiology, cell biology and cell culture, flow cytometry and/or molecular biology

Preferred Qualifications:

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

WORKING CONDITIONS AND PHYSICAL DEMANDS

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

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

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

Apply Now
Quality Systems Engineer II Quality Assurance Cambridge

POSITION SUMMARY

Department Description:

The Quality Systems Department manages Change and Design Control, Periodic Product Review, Inspection Readiness, Product Quality Reviews, Management Reviews and Risk Management.  QS ensures compliance with company procedures and industry standards in support of cell therapy products.

Quality Systems Engineers are focused on the oversight of the Quality Systems that allow for efficient and compliant execution of operational projects.  QS Engineers work closely with subject matter experts to facilitate the development and rapid adoption of value-added changes and processes, ensuring implementation in compliance with regulations, procedures and policies.

Position Summary:

The QS Engineer II will assist in ensuring that quality systems are in place and cGMP compliance is maintained.  Work and decisions will be based on a collaborative culture with individuals throughout the facility.

ESSENTIAL FUNCTIONS

Essential Functions:

  • Draft and revise procedures as required to ensure that documentation and operations meet established requirements of regulations, cGMPs, and internal SOPs and company policies.
  • Apply and maintain quality standards and procedures for quality systems.
  • Review executed cGMP documents and participate in or lead the implementation of systems, processing and storage of cGMP information.
  • Monitor the status of assigned quality system(s), providing periodic reports and status updates on the overall performance of the quality system(s).
  • Operate in an environment of strict timelines.

Key Functions may be in support of one or more of the following:

Change Control/Design Control

  • Oversee and or support the process of change control approval from evaluation of an initial proposal, through approval, implementation, closure and effectiveness review.
  • Provide QA oversight of change controls to ensure that they meet the requirements of industry standards and procedures, and are clearly written and appropriately justified. Provide QA approval of those changes at various points in the change life cycle, utilizing a quality management system electronic workflow.
  • Apply and interpret industry standards and local procedures governing the change control process to proposed changes, consulting with QA management as appropriate. Work with project teams to determine the change control approach for projects.
  • Verify the completeness and correctness of supporting documentation for changes, including items such as engineering studies, validation protocols, technical reports, engineering drawings and SOP changes.
  • Monitor the status of open changes, providing periodic reports and status updates on the overall performance of the change control system.

Risk Management

  • Assist with scheduling and driving activities of the risk management program with respect to scheduling meetings, developing quality documentation and data management.
  • Help ensure that manufacturing sites comply with the requirements of the risk management program and complete assessments and reports in a timely manner according to regulations, procedures and policies.
  • Participate in the risk assessment process as it relates to assisting with training of personnel, categorizing risk and assigning report numbers.
  • Provide clear and concise reports of risk management activities/assignments throughout the site and provide key metrics that monitor compliance for the risk management program.

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.

Required Education and Experience:

  • Bachelor’s degree or equivalent with 2+ years of relevant Quality/Compliance experience in a cGMP biotech or pharmaceutical regulated industry.
  • Experience performing work that consistently requires independent decision making and the exercise of independent judgment and discretion in a cGMP environment.
  • Experience writing and reviewing technical cGMP documents.

Preferred Education and Experience:

  • A strong understanding of Medical Device and Biologics FDA regulations.
  • Strong working knowledge of Trackwise or other quality management systems.
  • Proven Risk Management/FMEA experience/knowledge.
  • Good project management skills and working knowledge of statistical techniques.
  • Experience serving as a Subject Matter Expert (SME) in regulatory inspections.
  • Experience presenting in a group setting in areas of subject matter expertise.
  • Experience influencing colleagues and management in a cross-functional environment.
  • Strong written and verbal communication.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Occasional overtime may be required for support of site inspections.

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
Senior Accountant Finance and Accounting Cambridge

Vericel, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Finance and Accounting 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 into the Assistant Controller at Vericel, this individual will also have direct exposure to the Finance leadership team and collaborate with various functional leaders at Vericel.  This is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a strong institutional shareholder base.

The Senior Accountant will be responsible for execution of cost accounting functions, reporting of actual results to management, and assisting in the fiscal planning and forecasting of consolidated COGS accounts.  The Senior Accountant will also be responsible for other areas in the close process including overseeing fixed assets.

ESSENTIAL FUNCTIONS

  • Analyze current cost accounting processes including inventory management, mapping processes and provide recommendations for future process changes
  • Analyze inventory transactions to ensure that all are appropriately recorded in sub-ledgers and general ledger. Includes the monthly recording of inventory reserve adjustments.
  • Complete account analyses and monthly balance sheet reconciliations for areas of responsibility
  • Contribute to monthly corporate forecasting and annual budgeting with emphasis on gross margin and working capital requirements
  • Manage inventory accuracy at offsite warehouse locations storing finished goods and raw materials
  • Maintain standard costs across all inventory items
  • Oversee inventory variance accounting, including purchase price variances, manufacturing variances and revaluation to ensure accurate accounting of such variances
  • Integrate with the Manufacturing and Supply Chain teams and establish yourself as a valued business partner
  • Prepare related audit schedules and other requests from internal/external auditors and partners
  • Educate management on the inventory process
  • Responsible for the timely and accurate completion of month end close tasks including journal entries and account reconciliations
  • Drive continuous process improvement in the inventory and cogs areas
  • Recommend and assist in the implementation of process improvements including automation within the ERP and other tools where possible, to simplify, standardize and streamline processes
  • Oversee SOX controls in inventory
  • Fixed asset management including reviewing depreciation, additions, etc.
  • Ad hoc projects 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:

  • 4-5+ years of experience; CPA preferred
  • Bachelor’s degree in accounting required
  • Big 4 or large regional accounting firm experience preferred
  • 2+ years Public company experience
  • Manufacturing experience, preferably in Life sciences/Biotech/Medtech
  • Experience with Excel, PowerPoint and Word
  • Strong willingness to be into the details and learn how transactions flow through the ERP
  • Strong written and verbal communication skills

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. QC Analyst Quality Control Cambridge

POSITION SUMMARY

Department Description:

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

Position Summary:

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

ESSENTIAL FUNCTIONS

Core Responsibilities:

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

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

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

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

Basic Qualifications:

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

Preferred Qualifications:

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

WORKING CONDITIONS AND PHYSICAL DEMANDS

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

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

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

Apply Now

NASDAQ: VCEL

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