Senior Manager, Global Process Development, Fill-Finish Operations

6084-Janssen Research & Development Legal Entity•Malvern, PA

About The Position

Johnson & Johnson is seeking a Senior Manager, Global Process Development, Fill-Finish Operations, based in Malvern, Pennsylvania. The role leads the non-clinical Fill-Finish operations team supplying vials, pre-filled syringes, and pre-filled cartridges to support development of innovative biotherapeutics. The role contributes to experiment design and execution, advances manufacturing technologies and approaches, improves standard procedures, and deploys digital tools to increase operational efficiency, support informed decisions, and enable lean technology transfer to GMP manufacturing sites. Responsibilities also include overseeing raw material procurement and inventory, troubleshooting manufacturing equipment, leading investigations and implementing corrective and preventive actions, and planning and executing CAPEX/OPEX. The Senior Manager mentors direct reports and junior team members while upholding Johnson & Johnson’s values in a dynamic research environment. The role is accountable for performance indicators including uptime, training, investigations, CAPAs, yield, production cadence, and operational availability. It collaborates across functions to streamline process development and technology transfers, supports departmental alignment, addresses resource needs, applies Lean principles, and identifies and benchmarks digital capabilities. The position also works with process engineers, drug delivery systems engineers, formulation scientists, and other teams to advance the pipeline, contribute to strategic initiatives, and mentor and upskill the workforce.

Requirements

Bachelor’s degree in Engineering, Science, Technical, or another relevant field.
Minimum of 8 years of relevant industry experience.
Minimum of 4 years of demonstrated leadership ability and experience managing, coaching, and/or mentoring high-performing cross-functional teams.
Demonstrated experience in biologics manufacturing.
Manufacturing leadership and operations experience.
Ability to influence and build relationships across organizational layers and with external partners.
Strong scientific communication and collaboration skills, with the ability to work effectively in a multidisciplinary team.

Nice To Haves

Advanced degree in Engineering, Science, Technical, or another relevant field.
Experience in drug product sterile manufacturing.
Multi-product manufacturing experience.
Experience or in-depth knowledge of regulatory filings.

Responsibilities

Lead the non-clinical Fill-Finish operations team supplying vials, pre-filled syringes, and pre-filled cartridges for biotherapeutic development.
Contribute to the design and execution of experiments and advance next-generation manufacturing technologies and approaches.
Improve standard procedures and champion deployment of digital tools for operational efficiency, informed decision-making, and lean technology transfer to GMP manufacturing sites.
Oversee raw material procurement and inventories.
Troubleshoot manufacturing equipment and lead investigations, including implementation of corrective and preventive actions.
Plan and execute CAPEX/OPEX.
Mentor direct reports, junior team members, and the broader workforce; contribute to workforce upskilling.
Achieve and improve KPIs and performance metrics related to uptime, training, investigations, CAPAs, yield, production cadence, and operational availability.
Collaborate with cross-functional teams to streamline process development and technology transfers while nurturing and empowering the operations team.
Foster continuous learning and improvement, and lead or support site functional and cross-functional structures for departmental alignment.
Address resource constraints and needs, champion operational and technical excellence, and implement Lean principles for process optimization.
Keep pace with digital technologies relevant to manufacturing, scout and benchmark new functionalities and capabilities, and connect across TDS development organizations to drive aligned value creation.
Collaborate with process engineers, drug delivery systems engineers, formulation scientists, and other multifunctional teams to advance the pipeline.
Contribute to strategic initiatives.