Senior Manager, Global Process Development, Fill-Finish Operations

Johnson & Johnson Innovative Medicine•Malvern, PA

1d•Hybrid

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 for the development of innovative biotherapeutics. The position contributes to designing and executing experiments, advancing next-generation manufacturing technologies and approaches, and improving standard procedures. It also champions and deploys digital tools for operational efficiency, informed decision-making, and lean technology transfer to GMP manufacturing sites. The Senior Manager oversees raw material procurement and inventory, troubleshoots manufacturing equipment, leads investigations and implementation of corrective and preventative actions, and plans and executes CAPEX/OPEX. The role mentors direct reports and junior team members and upholds Johnson & Johnson’s values in a dynamic research environment. The position works with multidisciplinary teams to advance the pipeline and improve biotherapeutic manufacturing solutions.

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 externally with 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.
Design and execute experiments, advance next-generation manufacturing technologies and approaches, and improve standard procedures.
Champion and deploy 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 preventative actions.
Plan and execute CAPEX/OPEX.
Mentor direct reports and junior team members; contribute to strategic initiatives and workforce development.
Achieve KPIs and monitor and improve 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 apply Lean principles to optimize processes.
Use digital tools and keep pace with emerging manufacturing technologies for operational efficiency and informed decision-making.
Scout and benchmark new functionalities and capabilities and connect across TDS development organizations to drive and align value creation.
Collaborate with process engineers, drug delivery systems engineers, formulation scientists, and other multifunctional teams to advance the pipeline.