Manager, Fill Finish Drug Product Manufacturing - Weekend Operations - 2nd Shift

PCI Pharma Services•San Diego, CA

4d•Onsite

About The Position

This position manages the day-to-day activities of fill and finish manufacturing and implements production processes, manufacturing equipment, and procedures to optimize operations and meet regulatory requirements. The Manager coordinates with other departments to plan, schedule, and execute production operations in a validated cGMP environment. The role supports second-shift weekend operations. The Manager directs Drug Product Manufacturing operations and leads employees in accordance with PCI Pharma Services policies and procedures. Responsibilities include recruiting and retaining talent, coaching and developing employees, overseeing onboarding and career development, setting performance standards, encouraging engagement, managing performance, and maintaining transparent communication. The role requires regular, reliable full-time attendance or attendance in accordance with the posted schedule, professional conduct, accountability for timely and quality results, and effective collaboration with internal departments and external clients. The position is based at 6175 Lusk Blvd, San Diego, CA 92121.

Requirements

Bachelor’s degree in a scientific discipline or equivalent experience.
At least seven years of related technical experience.
At least three years of leadership or supervisory experience.
Understanding of cGMPs and regulatory requirements.
Solid command of chemistry, including understanding of fillers and filling processes.
Understanding of QAD, Master Control, LIMS, and RAM.

Responsibilities

Oversee daily formulation, filtration, filling, and troubleshooting activities.
Review and generate batch records, including client calls and project management interactions.
Plan Drug Product Manufacturing schedules, coordinate preparation, and troubleshoot operational issues.
Participate in client calls, interactions, and meetings, including kickoff meetings, tours, and discussions of operational issues.
Manage internal investigations, including deviations, corrective and preventive actions, and product quality reviews.
Plan facility shutdowns, maintenance, HEPA certifications, and media fills.
Respond to client, QP, and regulatory inspections and revise SOPs and batch records as needed.
Coordinate quality interactions, including environmental monitoring, out-of-specification, and deviation investigations.
Direct and provide expert knowledge in the day-to-day function of Drug Product Manufacturing.
Identify, recruit, and retain talent; coach, mentor, engage, and develop the team.
Oversee new employee onboarding and provide career development, planning, and learning opportunities.
Set performance standards and encourage employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
Communicate organizational information through department and one-on-one meetings, email, and regular interpersonal communication.
Provide oversight and direction to employees in accordance with company policies and procedures.
Build working relationships with internal departments and external clients, collaborate with others, and align daily actions with department goals and company culture.