Manager, IT Manufacturing Execution Systems
Job Description
Job Description
At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).
Position Summary:
The MES System Manager will drive efficiency and reliability in our manufacturing processes. This role involves developing Manufacturing Execution System (MES) support strategies, collaborating with vendors, optimizing system performance, and ensuring compliance with GxP regulations.
Schedule:
This position is in-office from Monday – Thursday in our new Burlington, MA location, with flexibility to work remotely on Fridays.
ESSENTIAL FUNCTIONS
- Drive the development of an IT support strategy that synthesizes manufacturing process expertise, equipment design considerations, and quality requirements with advanced information technology capabilities. Apply conceptual and systems-level thinking to reduce downtime and enhance operational resilience across the organization.
- Provide thought leadership in assessing and implementing MES upgrades, hotfixes, and enhancements, collaborating with internal stakeholders and external partners. Evaluate ambiguous or intangible factors—such as evolving process needs, system interdependencies, and long-term maintainability—to determine optimal technical approaches.
- Oversee MES system performance management at a strategic level, interpreting complex diagnostic data and logs to anticipate risks, identify emerging issues, and guide the resolution of critical problems. Exercise independent judgment in selecting methodologies and prioritizing actions that may influence processes across the entire manufacturing function.
- Serve as a key strategic partner to Manufacturing leadership, cultivating a deep understanding of operational workflows and system configurations. Leverage this insight to provide informed, high-impact recommendations that optimize system performance and support organizational objectives.
- Provide oversight and escalation leadership for on-call support of EBR/APS systems, ensuring operational continuity and directing resources effectively to mitigate business impact.
- Act as a recognized internal subject matter expert, mentoring and developing internal and external MES resources. Shape team competencies and guide technical approaches to build organizational capability.
- Direct, support and document the architecture and configuration of external system interfaces, ensuring seamless and compliant data exchange across interconnected platforms and enabling integrated operational insights.
- Guide the creation, evaluation, and approval of SDLC and validation deliverables for GxP system implementations and enhancements. Apply independent judgment to ensure quality, compliance, and alignment with organizational risk tolerance.
- Lead and coordinate multiple concurrent IT initiatives within the MES ecosystem, balancing strategic priorities and resource constraints while ensuring solutions align with evolving business needs and long-term enterprise architecture.
- Evaluate complex and evolving business requirements, translating them into effective technical strategies. Engage diverse stakeholders, influence decision-making, and secure alignment on system enhancements and organizational change initiatives.
Qualifications:
- Bachelor's degree in Computer Science, Information Technology, or Business Administration or equivalent years of experience.
- 12+ years of experience with enterprise systems, ideally in MES solution deployment and knowledge of MES technologies such as Siemens OpCenter Execution Pharma (EBR) and OpCenter APS (Scheduling) would be preferable.
- Experience in Pharmaceutical, Biotechnology, or Life Science industry.
- Database administration knowledge for Oracle, SQL and/or other platforms is preferable.
- Knowledge of business intelligence platforms such as PowerBI and other data ETL and modeling tools is preferred.
- Demonstrated leadership skills and experience working in diverse, multi-disciplined work groups.
- Knowledge of GMPs, GAMP 5, 21 CFR Part 11, Annex 11, MHRA/FDA Data Integrity preferred
Why Vericel?
- Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
- Career Growth: Be a part of a growing organization with opportunities to expand your impact.
- Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.
The salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $143,000 to $170,000 annually.
The actual salary offered will be determined based on factors such as the candidate’s qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above.
In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited.
EEO Statement
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/Affirmative Action Employer.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.