Position Summary:

Responsible for building and maintaining daily operations scheduling operations, process improvement, and Business Process ownership for OpCenter APS scheduling and reporting. Oversees the training programs for Cell Therapy Manufacturing. Provides scheduling and resource utilization management support for cell therapy operations Value Stream. Leadership as Project Manager or Functional Representative for complex Industrial Culture/Operational Excellence projects, including process improvements, and technical transfers.

Duties and Responsibilites:

Scheduling and Operations Utilization Responsibilities

• Provide direct management to Production Schedulers, and coaching to Manufacturing Staff trained as scheduling back-ups. Responsible for maintaining Scheduler qualifications to provide vacation coverage.
• Provides management support for ongoing cell therapy manufacturing operations, including mentoring of manufacturing staff.
• Leadership as Project Manager or Functional Representative for implementation of Continuous Improvement and
• LeanPrograms in support of improving overall Operations Utilization
  • Build systems and processes that create visibility, efficiency andplanning tools and systems to increase efficiency andour and resourceutilizationacross Operations.
  • Use Lean Methodologies to Diagnose, Develop, and Implement Lean Programs within MFG and cross-functionally

Systems and Applications Responsibilities

• System Owner/Admin for any electronic systems that support Cell Therapy Manufacturing Operations, including OpCenter Execution Pharma and OpCenter APS.
• Owner of all SOPs and training content related tooperations scheduling and reporting systems.
• Collaborates with Manufacturing teams and the IT group to identify and prioritize upgrades and improvements to OpCenter.
• Provide first line support to Manufacturing operations for technical issues related to OpCenter.
• Function as a Cell Therapies Operations Scheduling and OpCenter subject matter expert (SME).
• Participate in internal and external audits in this capacity.

Additional Responsibilities

• Engage and support in Industrial Culture tools and projects. This role requires Lean/Six Sigma Certification within the first year in the role.
• Participate in the development of manufacturing policies (including operational, safety and quality programs).
• Ensure compliance withappropriate internaland regulatory policies and procedures.
• Conduct annual performance reviews and provide regular feedback based on goals.
• Organize the staff and workload to meet or exceed productivity performance standards.
• Other duties as assignedby Manufacturing Management.

Basic Qualifications:

• Bachelor's Degree (Life Sciences or related field) with 3+ years, or Associate's degree or GED/equivalent with 5+ years of experience working in a cGMP environment in the biotech or pharmaceutical industry or equivalent.
• Must possess solid working knowledge of MS Office (Word/Excel/PowerPoint/Project).
• Work independently under minimal supervision and direction.
• Strong verbal and communication skills.

Preferred Qualifications:

• Certified Lean/Six Sigma Green Belt or higher.
• Experience with planning and scheduling in a cGMP manufacturing environment.
• Experience with Manufacturing Execution Systems preferred (OpCenter, Siemens).
• Demonstrated ability to take on a leadership of cross-functional teams.
• Experience in high volume and fast-paced materials and cleanroom environment.
• Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies.
• Organizational and planning skills and the ability to cooperate with others in a team environment will be critical to success.
• Qualified as an On-Job Trainer.

Working Conditions and Physical Demands:

• This is a Monday-Friday role with 3 days in our Burlington office, and 2 days in our Cambridge Office.
• May be required to sit for long periods of time while performing cell culture operations.
• Ability to gown and gain entry to manufacturing areas.
• Ability to lift up to 50lbs.

The salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $127,000 to $140,000 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.