Senior Director, Manufacturing Operations

Position Summary & Role

The Senior Director, Manufacturing Operations is responsible for manufacturing of cell therapy and viral vector products at the Resilience Philadelphia facility and providing cross-functional leadership of the manufacturing value stream at the site. Reporting to the Head of Cell Therapy Technical Operations, the incumbent will build and develop a team of manufacturing and manufacturing technology professionals, manage GMP cell therapy and viral vector operations, and oversee technology transfer from internal development teams and external partners to manufacturing.

The ideal candidate will have deep expertise in biologics manufacturing and experience leading teams of manufacturing professionals in a clinical and / or commercial manufacturing environment.

This is a unique opportunity to join a leading-edge manufacturing technology company and be a key member of the site leadership team.

Job Responsibilities

• Lead the manufacturing organization, including cell therapy and viral vector manufacturing operations and manufacturing technology at the Resilience Philadelphia facility.

• Lead a safety first culture, ensuring operations are conducted in accordance with all applicable Environmental, Health and Safety (EHS) regulations, policies, and procedures.

• Partner with the Quality organization to ensure operations are executed in compliance with Current Good Manufacturing Practice and in accordance with company and site policies and procedures.

• Develop and execute manufacturing plans aligned with the demand forecast ensuring effective capacity and resource management and consistent performance to plan.

• Embed operational excellence principles within operations to drive effective planning, execution, reporting, analysis, problem solving, and communication within the team and across the site and network.

• Own and oversee execution of the site’s GMP new product introduction process.

• Develop and execute a robust operations training program to ensure team members have a clear understanding of manufacturing & compliance procedures and the science behind the procedures.

• Manage operational budgets and capital plans in support of company and departmental objectives

• Work with Supply Chain and Engineering to develop capacity and facility master plans.

• Serve as the site business owner for the manufacturing execution system (MES), partnering with the Digital organization to lead implementation and adoption of digital manufacturing operations.

• Assist in the preparation of regulatory filings and serve as a key subject matter expert during regulatory interactions.

Preferred Experience, Education & Qualifications

• Bachelor’s degree in scientific or engineering discipline required, advanced degree (MS, PhD, or MBA) preferred.

• 12+ years of relevant GMP manufacturing experience with at least 5 years of experience leading a biologics manufacturing organization.

• Strong understanding of FDA and EMA regulations and relevant guidelines for GMP manufacturing required.

• Knowledge of and prior experience with digital systems in a GMP manufacturing environment.

• Prior experience in advanced therapies (cell or gene therapy) and with aseptic processing preferred.

• Formal training and certification and experience deploying operational excellence in a manufacturing environment strongly preferred.

Other Ideal Personal Characteristics:

• Results oriented, resourceful individual with a highly entrepreneurial style and the ability to work in a fast-moving and dynamic environment

• Exceptional communication and influencing skills with the ability to inspire confidence and work successfully with varied audiences

• The ability to build partnerships and create a culture of collaboration and teamwork that fosters open communication and constructive conflict resolution

• Able to work with multiple stakeholders and a demonstrated ability to adjust workload based upon changing priorities while delivering results.