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

Front line, direct sales position responsible for generating demand for Vericel products and services by fostering HCP interest in, education of, access to, and buy-in at targeted burn centers.  Success measured by goal achievement in alignment with Vericel values.

ESSENTIAL FUNCTIONS

Core Responsibilities:

Direct sales calls to key decision makers at targeted burn centers, including surgeons and support personnel, to engage in the selling process:

• Connecting with stakeholders to the point of earning trusted advisor status
• Discovering the current state at targeted accounts specific to burn treatment, including pain points, blind spots, and opportunities for Epicel to bring value
• Aligning with the key stakeholders regarding their pain points, blind spots, and where Vericel would bring value, assertively and credibly managing objections and misconceptions
• Advancing the key stakeholders to action, including biopsies of appropriate patients and f/u usage of Epicel with patients for whom it makes sense.

Develop and manage complex accounts via:

• Identifying and connecting with key stakeholders & support staff (account mapping)
• Developing and executing key account strategic plans (account planning)
• Maintaining an appropriate and consistent presence within key accounts among key stakeholders
• Maintaining complete awareness of evolving patient population and advocating for appropriate Vericel patients.
• Staying aware of competitive activities and threats
• Setting accounts up for success with Vericel products by providing or arranging (via BCS) appropriate training and support

Foster access to and procurement of Vericel products:

• Determining procurement process at each targeted account
• Leveraging reimbursement and coding expertise to optimize Vericel product coverage
• Ensuring account approval for Vericel products to the highest levels in key accounts
• Presenting to VAC and P&T committees

Manage territory for optimal performance and effectiveness

• Establishing and execute routing that results in appropriate coverage levels according to target emphasis
• Maintaining up-to-date records of each account and stakeholders within via CRM tool
• Creating and executing territory business plans that prioritize efforts and resources appropriately
• Attending conferences where presence offers strategic territorial value
• Attending procedures in key accounts where presence will enhance selling position

Partner with Burn Clinical Specialist partner to optimize management of all Epicel cases

Develop product advocates for peer-to-peer impact

• Connecting BTS-CS with stakeholders to develop case studies, white papers, advocates for conferences & Vericel programs, etc.

Expertly leverage promotional materials to effectively tell the Vericel story in a manner that inspires action, including marketing, clinical, and operational information

Work in partnership with BTS-CS (Clinical Support) partner(s) to:

• Optimize Vericel presence in key accounts and select procedures
• Leverage their experience to secure introductions to key stakeholders at key accounts
• Leverage their expertise to help activate dormant and new accounts
• Advance progress in KOL development

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Basic Qualifications:

• A professional approach that sees patient welfare as the highest priority, with a strong drive to connect our products and services with every patient who will benefit.
• 3 to 5+ years of experience of hospital-based specialty healthcare products 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 “hunter” approach
• Strong clinical and scientific acumen, particularly in burns or wound care.
• Understanding of medical reimbursement (billing, coding, coverage, and payment) in the healthcare system and ability to work to resolve billing issues with providers.
• Ability to thrive in a cross-functional team.
• Bachelor’s or Master’s degree.   Experience with burns or burn nursing a significant plus.

 

Preferred Qualifications:

• Continuous training on technical and product knowledge.

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

WORKING CONDITIONS AND PHYSICAL DEMANDS

Must manage significant travel demands, including occasional weekend days

POSITION SUMMARY

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 to the Assistant Controller at Vericel, this individual will also have direct exposure to the CFO and Corporate Controller as part of the Finance leadership team 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 Associate Director, Accounting and External Reporting will be responsible for leading the SEC reporting and oversee various technical accounting areas such as stock-based compensation, leases, revenue recognition and investments. This individual will work closely with the Assistant Controller and Corporate Controller to ensure all SEC filings are filed accurately and timely and provide leadership to the revenue team. In this highly visible role, the Associate Director, Accounting and External Reporting  will work cross-functionally with leaders across the company to support, maintain and enhance our Accounting processes and SEC reporting and support the business by providing accounting guidance on various initiatives. Additionally, the Associate Director, Accounting and External Reporting  will partner with the Assistant Controller, Corporate Controller and other leaders on strategic projects, including evaluating potential business development and other potential strategic and financing transactions.

• Manage and execute the SEC filings including the 10-K, 10-Q’s and support the annual proxy
• Collaborate with FP&A, IR and Legal on various internal and external reporting matters
• Participate in quarterly earnings process, including review of earnings release and earnings call script and presentations
• Oversee the preparation of the consolidation including the preparation of the balance sheet, income statement and cash flow statements
• Oversee accounting and technical matters related to investments, leases, equity, stock compensation and any other complex areas
• Collaborate with the Accounting Manager to ensure timely and accurate completion of the month end close
• Support revenue accounting including GAAP compliance
• Advise on complex revenue matters including estimates and reserves
• Work closely with external auditors to drive timely accounting conclusions and disclosures. Act as a critical point of contact throughout the audit process for external/internal auditors and consultants on technical matters and financial reporting
• Drive continuous process improvement in both the Finance/Accounting teams as well as in external reporting and accounting processes
• Research application of accounting standards, determine potential effects to Vericel of new accounting standards and effectively communicate the impact to stakeholders throughout the company, including Senior Management
• Research various technical accounting matters, conclude on the proper U.S. GAAP treatment, document technical accounting memos and present to Senior Management and/or external auditors as needed.
• Develop, document and maintain accounting policies, including updating or developing new policies to ensure consistency and compliance with GAAP and other reporting requirements; Provide ongoing training of Company’s accounting policies
• 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
• Manage, train and develop team members
• 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.

Basic Qualifications:

• 8+ years of experience; CPA required
• Bachelor’s degree in accounting required; master’s degree in accounting preferred
• Big 4 or large regional accounting firm experience
• 3+ years Public company experience
• Life sciences/Biotech/Medtech experience preferred
• Expertise and experience in U.S. GAAP, ASC 606 and 842 and SOX
• Experience with Excel, PowerPoint and Word
• Experience with financial reporting tools such as Workiva and Adaptive Insights
• Strategic mindset with ability to manage multiple deliverables and projects
• Detail-oriented and strong problem-solving and issue resolution skills
• Strong written and verbal communication skills

POSITION SUMMARY

The Associate Director, Regulatory Affairs manages, evaluates and completes regulatory projects consistent with the company goals. Responsible for timely planning and coordination of regulatory submissions. Provides guidance to cross-functional teams on regulatory strategy and tactics. Keeps abreast of regulatory procedures and practices. The incumbent will work independently with appropriate oversight and is expected to identify and act on activities without requiring immediate direction.

ESSENTIAL FUNCTIONS

• With minimal supervision, plan and manage regulatory activities related to assigned development projects. Assist in developing and implementing strategies for the earliest possible approvals of regulatory submissions associated with assigned development projects.
• Manage the assembly and timely submission of 510Ks, INDs, BLAs and other dossiers as required for investigation and registration of drugs, biologics and devices in the US.
• Ensure regulatory submissions are maintained in compliance with regulatory requirements.
• Represent the company in its dealings with the FDA and other regulatory authorities, as appropriate.
• Participate on project teams and provide expertise on regulatory matters.
• Develop and maintain current regulatory knowledge and advise management of significant developments.
• Contribute to improvements in department best practices and SOPs.
• Perform other duties as required, interfacing with other departments, CROs, and external vendors as needed.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Education

• Bachelor of Science in a scientific discipline.
• Master of Science (preferred)

Basic Qualifications

• 5+ years direct Regulatory Affairs experience in the US market.
• Experience with drugs, biologics and medical devices.  Previous experience with combination products and/or botanicals a plus.
• Experience and knowledge in preparation of 510K’s, BLAs, INDs and supportive amendments and supplements.
• Experience with prescription drug advertising regulations and promotional review committee’s
• Experience with labeling and UDI regulations
• Working knowledge of FDA regulations and understanding of FDA structure and function.
• Working knowledge of eCTD elements and structure.
• Strong regulatory writing skills and use of Microsoft Word.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually, within a multidisciplinary team, or with external partners and vendors.
• Possess excellent written and verbal communication skills.

WORKING CONDITIONS AND PHYSICAL DEMANDS

Occasional travel (5-10%)

POSITION SUMMARY

Department Description:

Vericel Customer Care Department is responsible for order processing and provides optimum service to both internal and external customers.

Position Summary:

The Customer Care Associate provides daily support for all duties relating to the processing of customer orders via telephone, fax, email, mail orders, price checks, tracking of orders, and confirmation of discounts all within a cGMP environment.

ESSENTIAL FUNCTIONS

Core Responsibilities:

• Provide optimal customer service.  All activities are conducted in accordance with company policy, SOPs and HIPAA, FDA, or other internal/external regulatory requirements.
• Promote quality customer service standards to ensure high levels are achieved.
• Resolve complex problems, gather and interpret data.
• Participate in internal and external audits.
• Work closely with the sales organization to resolve complex customer issues pertaining to daily operations.
• Effectively build working relationships with various internal/external groups such as: Manufacturing, Distribution, Sales, Marketing, Finance, QA, etc.
• Utilize superior written, verbal and phone skills to handle sensitive information in a timely and organized manner.
• Contribute to or manage special projects, or perform additional responsibilities as assigned by manager.
• Be available on-call on a rotating schedule.
• Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:   

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

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

Basic Qualifications:

• High School diploma or equivalent and 2+ years of customer service experience.
• Proficient in Microsoft Office Outlook, Word, and Excel.

Preferred Qualifications:

• Bachelors degree.
• Experience in ERP systems.

WORKING CONDITIONS AND PHYSICAL DEMANDS

• Able to work a flexible schedule.

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.
• Other projects and assignments as needed.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:   

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

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

Basic Qualifications:

• Bachelor’s Degree, with a science, business or marketing degree preferred.
• Non-Degree candidates must have 8 plus years of relevant surgical sales experience, orthopedics and particularly sports medicine preferred.
• 3+ years of proven successful sales results.  OR sales and orthopedic background preferred.
• Knowledge of anatomy and physiology strongly desired in order to understand where and how products work clinically.
• Candidate will need to undergo and successfully pass hospital credentialing requirements in order to perform certain aspects of their job, including a 10 panel drug screen.
• Self-motivated, high commitment and dedication with proactive mindset.
• Detail oriented with strong analytical and problem-solving skills along with the ability to review voluminous amounts of information (e.g., data tables) and distill relevant information.
• Ability to develop and manage relationships to meet short, and long-term business objectives.
• Team player with the ability to lead and build consensus and to work on multiple projects simultaneously.
• Able to demonstrate flexibility, independence, initiative, creativity, confidentiality, integrity, stability and efficiency.
• Excellent verbal and written communication, strong presentation and training skills, and interpersonal and relationship building skills.
• Project management skills and proficiency with Microsoft applications.

WORKING CONDITIONS AND PHYSICAL DEMANDS

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

POSITION SUMMARY

Position Summary

The Lead Statistical Programmer will work with the Clinical Affairs and Clinical Operations group and support data analysis and reporting for clinical trials and regulatory submissions. He/She leads statistical programming activities internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components and ad hoc analyses. He/she partners with Biostatistics and data management to deliver high quality, submission ready statistical outputs. This person is also responsible for providing input to the overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to the clinical project team counterparts and estimating resource needs. He/she accomplishes tasks and communicates issues, as necessary, to senior management. This includes communication and quality oversight of vendors. He/she is comfortable representing the Statistical Programming perspective to the clinical project team and is often the sole functional representative. He/she develops and implements standard programming practices while also ensuring that they are employed across studies. He/she also contributes to improve the tools and processes for Statistical Programming.

ESSENTIAL FUNCTIONS

Core Responsibilities

 

• Serve as the main point of contact for stat programming function for assigned projects, support multiple stakeholder groups which include biostats, clinical development, clinical operations, data management, medical affairs, regulatory, and safety evaluation, provide oversight to vendors.
• Develop and validate of technical programming specifications (e.g., SDTM mapping specification and ADaM specification) and programs, and generate SDTM and ADaM datasets, tables, figures and listings.
• Manage and contribute to the end-to-end programming of deliverables from CRF collections through electronic submission including preparation of electronic submissions (ESUB) components (reviewers guides, annotated CRF, define and XPTs)
• Ensure that out-sourced statistical programming/data management tasks are performed according to GCP, approved SOPs, and protocol. Monitor quality issues with vendors and escalates internally when needed.
• Support study-level/drug program audit and inspection readiness activities 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:

• Bachelor’s degree required, Masters or PhD in statistics, computer science, mathematics, engineering, or life science preferred.
• PhD with 2+ years, MS with 6+, BS with 8+ years of programming experience in the bio-pharmaceutical industry

• Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise
• Excellent knowledge of clinical trial research methodologies, CDISC, ICH, GCP, and 21 CFR Part 11 rules and regulations.
• Familiarity with clinical data management concepts and experience of data monitoring and cleaning Preferred Qualifications
• Experience in ad hoc programming to produce analysis for various projects in a short timeframe.
• Thorough understanding of the clinical drug development process (clinical trials Phase I-IV).
• Knowledge of regulatory requirements concerning electronic submission standards and experience in delivering one or more submissions to regulatory authorities globally.
• Excellent interpersonal skills and ability to negotiate and collaborate effectively
• Strong analytical skills and Attention to detail including proven ability to manage some competing priorities.

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 Manager, 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 6+ years, or Associate’s degree with 7+ years, or GED or equivalent with 9+ 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

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

Leadership Qualifications:

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

This includes:

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

Basic Qualifications:

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

Preferred Qualifications:

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

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

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

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. Following NexoBrid’s approval, activities include but are not limited to, calling on targeted Burn Centers to develop HCP interest, utilization protocols and advocacy, providing product in servicing, 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

POSITION SUMMARY

Lead a sales culture of performance through execution excellence specific to strategy, tactical plans and key initiatives.

ESSENTIAL FUNCTIONS

Core Responsibilities:

• Support an environment that best allows Account Managers (AM) to succeed, including focusing on the welfare of our stakeholders and the patients they serve.
• Meet or exceed sales goals and achieve results through teamwork and collaboration.
• Provide leadership in development of selling strategies.
• Create a high performing organization through recruiting, training, performance management, coaching and mentoring of team.
• Maximize time in the field with Account Managers to offer continuous and ongoing coaching and development.
• Partner with Account Managers and Burn Clinical Specialists to optimize management of all Epicel and Nexobrid cases; must have ability to manage a case independently.
• Build a network of customer and industry contacts for sales development and marketing partnership.
• Maintain current knowledge of market and competitive trends.
• Ensure compliance with policies and procedures.
• Collaborate and partner effectively with peer and support functions.
• Organize and execute meetings that yield shared insight and result in actionable next steps.
• Communicate effectively and positively influence the behavior of others.
• Trust the actions of team members and assume best of intentions with due diligence to verify results
• Work closely with Account Managers to plan territory coverage and develop customer targeting strategies. Effectively deploy strategies that maximize human and financial resources.
• Foster appropriate coordination between the AMs and the Burn Clinical Specialists (BSC)
• Additional responsibilities include: participate in cross-functional strategy sessions, identify market trends through data analysis, proactively work with sales training team to ensure deployment of training to staff, present at Regional and National Sales Meetings, and effectively manage administrative and financial responsibilities

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:   

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

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

Basic Qualifications:

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

Preferred Qualifications:

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

WORKING CONDITIONS AND PHYSICAL DEMANDS

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

POSITION SUMMARY

Department Description:

Manufacturing of cell therapy products.

Position Summary:

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

ESSENTIAL FUNCTIONS

Core Responsibilities:

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

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:   

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

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

Basic Qualifications:

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

Preferred Qualifications:

• Experience working in an ISO 7 cleanroom environment.

WORKING CONDITIONS AND PHYSICAL DEMANDS

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

POSITION SUMMARY

Territory Development Representative is responsible for MACI sales and sales support.

ESSENTIAL FUNCTIONS

Core Responsibilities:

• Develop a deep understanding of MACI, knee anatomy, cartilage physiology, cartilage injuries as well as concomitant pathologies that typically accompany patients with cartilage disease.  The deep understanding to include the full spectrum of cartilage repair techniques, products and other related knee procedures through company training, self-education as well as business support selling activities
• Support / proctorship of MACI surgical cases, including biopsies and implants
• Provide customer in-services and training to surgeons, including fellows, residents, and support staff (nursing, PAs, etc.)
• Coordinating surgical and training instrumentation transport, delivery and inventory logistics
• Support sales representative by generating new sales opportunities and maintain existing business and relationships.
• Explore and engage in selling opportunities by building relationships and rapport with key clinical staff
• Take ownership of professional development and proactively engage with Field Sales Trainers and other resources to enhance technical, clinical and sales competencies
• Work as team player to ensure quarterly and annual targets are achieved.

 

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:   

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

• Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.

Basic Qualifications:

• Bachelor’s Degree, with a science, business or marketing degree preferred.
• 1 year of documented B2B experience in sales, with experience in surgery /medical device applications preferred
• Knowledge of anatomy and physiology strongly desired in order to understand where and how products work clinically.
• Candidate will need to undergo and successfully pass hospital credentialing requirements in order to perform certain aspects of their job, including full immunization and a 10-panel drug screen.
• Self-motivated, high commitment and dedication with proactive mindset.
• Detail oriented with strong analytical and problem-solving skills along with the ability to review voluminous amounts of information (e.g., data tables) and distill relevant information.
• Ability to develop and manage relationships to meet short, and long-term business objectives.
• Team player with the ability to lead and build consensus and to work on multiple projects simultaneously.
• Able to demonstrate flexibility, independence, initiative, creativity, confidentiality, integrity, stability and efficiency.
• Excellent verbal and written communication, strong presentation and training skills, and interpersonal and relationship building skills.
• Project management skills and proficiency with Microsoft applications.
• Willingness and ability to relocate within the territory or region in order to accommodate business need when an open territory does become available.

WORKING CONDITIONS AND PHYSICAL DEMANDS

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

POSITION SUMMARY

Department Description:

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

Position Summary:

Responsible for performing validation projects in a GMP biotech manufacturing facility.

ESSENTIAL FUNCTIONS

Core Responsibilities:

• Master core responsibilities of an Engineer, Validation, I.
• Develop and publish new validation project plans and protocols, execute protocols and write final reports with little to no supervision.
• Participate in equipment failure investigations, corrective/preventive actions and equipment release.  Provide final approval for equipment release.
• Provide technical assistance to less experienced technicians/specialists.
• Routine and effective communication with immediate supervisor and other personnel within the group in addition to outside the department.
• Review and approve validation and calibration documentation.
• Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

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

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

Basic Qualifications:

• Bachelor's Degree or equivalent and 4+ years of validation experience.
• Master’s Degree or equivalent and 2+ years of validation experience.
• 3+ years of experienced with process, equipment, utility, and/or software validation in a GMP regulated environment.

 

Preferred Qualifications:

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

WORKING CONDITIONS AND PHYSICAL DEMANDS

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