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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 performance.
  • 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.

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
Clinical Account Specialist, Miami FL Sales-MACI Miami, Fl - 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

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

ESSENTIAL FUNCTIONS

Core Responsibilities: 

  • Call on orthopedic surgeons and specialists in cartilage repair to deliver a targeted sales message based on accurate clinical information, using approved sales and marketing materials.
  • Attend surgical implantation procedures, as needed, and provide education, training and support to clinical personnel and other staff associated with use and implant of Vericel Products.
  • Ensure completion of Surgeon product training required by FDA.
  • Work with customers to educate on product and procedure reimbursement across different insurance carriers and facilities, and foster a relationship with case management team.
  • Utilize corporate resources i.e. education speaker programs, lunch budgets, and local conference attendance.
  • Knows, understands, and follows Vericel and Government regulations.
  • Territory Borders include Miami and Fort Myers area
  • 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 Miami or Fort Myers 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
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
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
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

  • Travel up to 20%

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, Event Planning Marketing Cambridge

POSITION SUMMARY

The Manager, Event Management reports to Senior Director of Marketing and is primarily responsible for planning, coordinating and managing all aspects of commercial events, including professional tradeshows for Vericel’s Sports Medicine (MACI®) and Burn Care (Epicel® and NexoBrid®) franchises.  Event management responsibilities extend to internal sales meetings, award trips, customer training programs and events as well as internal corporate meetings as needed.  The management of tradeshows and commercial meetings  requires deep understanding of brand strategy and promotional tactics.  This role collaborates closely with marketing and brand management to ensure consistent branding and messaging as well as achievement of commercial event objectives.  This role hasfull responsibility for budget management, event coordination, exhibit space management, event communications, transportation, hotel accommodations, meeting invitations (internal and external customers), agendas, expense reporting, food service, technology, office support, and special requests. 

ESSENTIAL FUNCTIONS

Conferences & events:

  • Facilitate Vericel’s participation in national & regional events associated with the MACI & Burn Care franchises
  • Plan and executes internal and external in-person meetings, including venue sourcing, contract negotiations, budgeting, food & beverage, travel and accommodation coordination, audio visual production as well as on-site execution
  • Coordinate a calendar of industry events in support of Vericel’s commercial objectives, including event planning, booth organization and logistics support
  • Collaborate with Sales & Sales Operations Directors to coordinate national sales meeting events
  • Collaborate with Advocacy Development to coordinate and administer professional peer to peer programs
  • Enhance Vericel’s event presence through continual optimization of event planning and strategy
  • Deliver on event objectives established in the brand planning process and provide quarterly updates on metrics to commercial leadership  

Additional responsibilities:

  • Administer the budget process through agency negotiations, vendor management, expense monitoring and budget forecasting
  • Adhere to all relevant internal and external policies & guidelines related to the team’s activities and deliverables
  • Coordinate and plan internal company events and meetings as needed.

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 in Business/Marketing/related and 3+ years of professional experience related to events management
  • Outstanding interpersonal, collaboration and teamwork skills and experience
  • Excellent verbal and written communication skills
  • Proven ability to work independently. Highly organized and effective in handling multiple detail-oriented projects in a fast-paced environment. The candidate must exercise discretion and judgment in handling confidential/proprietary information.
  • Strong administrative and computer skills, including proficiency in MS Office (Outlook, PowerPoint, Excel, Power BI and Word).
  • Resourcefulness and responsiveness are essential.
  • Ability to interact with various levels of business functions and professionals in and outside of the organization.
  • Ability to conduct topical research by synthesizing information from multiple sources (academic journals, newspapers, online publications, interviews etc.), analyze information and create relevant reports.
  • High attention to detail and precision in analyses and creating materials

Preferred Qualifications:

  • Experience collaborating with sales and marketing colleagues in the pharmaceutical, biotech or medical device industry
  • Experience with promotional compliance in a healthcare-related industry, or other regulated industry. 
  • Experience executing the full lifecycle of an event, including sourcing, contract negotiation, registration, housing, AV, menu selection, show floor management, sponsorship management, branding, signage, and transportation
  • Experience negotiating statements of work with vendor partners and effectively managing an expense budget
  • Experience facilitating the complete lifecycle of a sponsored event
  • Strong project management skills.
  • Experience with Adobe Acrobat Pro, eProcurement, CRM Systems (Microsoft Dynamics, Veeva), Concur expense management.

WORKING CONDITIONS AND PHYSICAL DEMANDS

Willingness to travel approximately 25% annually

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 - Mid-Atlantic 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
Nexobrid Account Manager - New England 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 - 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
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.

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
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

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February 1, 2023
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