Manager, Drug Product Manufacturing - 2nd Shift

PCI Pharma Services•San Diego, CA

21h

About The Position

The Manager, Drug Product Manufacturing is responsible for managing the day-to-day activities of fill-and-finish manufacturing and implementing production processes, equipment, and procedures to optimize operations and meet regulatory requirements. The role coordinates with other departments to plan, schedule, and execute production in a validated cGMP environment. The second shift generally starts at 2:00 p.m.; employees working second-shift hours are eligible for a 10% pay differential. The manager directs day-to-day Drug Product Manufacturing operations and provides leadership to the team. This includes recruiting and retaining talent, coaching and developing employees, overseeing onboarding and performance management, communicating organization information, and ensuring work aligns with company policies and goals. The position also builds relationships with internal departments and external clients, promotes a safe and environmentally sustainable workplace, and supports PCI Pharma Services’ culture and values.

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 operations, including formulation, filtration, filling, and troubleshooting.
Review and generate batch records, and participate in client calls and project management interactions.
Plan Drug Product Manufacturing activities, including defining schedules, coordinating preparation, and troubleshooting.
Participate in client calls, interactions, and meetings, including kickoff meetings, tours, and discussions of operational issues.
Conduct internal investigations, including deviations, corrective and preventive actions, and product quality reviews.
Plan facility activities, including shutdowns, maintenance, HEPA certifications, and media fills.
Respond to client and regulatory audits and inspections, and revise SOPs and batch records as needed.
Coordinate with Quality on environmental monitoring, out-of-specification, and deviation investigations.
Maintain regular and reliable attendance on a full-time basis or in accordance with the posted schedule.
Exhibit professional behavior with internal and external business associates and proactively complete assignments on schedule and to quality standards.
Build effective working relationships with internal departments and external clients, and collaborate with others, including in difficult or high-pressure situations.
Support a safe and environmentally sustainable workplace by ensuring compliance with PCI EHS policies and procedures.
Direct and provide expert knowledge in the day-to-day function of Drug Product Manufacturing.
Identify, recruit, and retain talent; champion company culture and empower employees to take responsibility for their work and goals.
Coach, mentor, engage, and develop team members, including overseeing onboarding and providing career-development planning and learning opportunities.
Set performance standards and encourage employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
Maintain transparent communication through department and one-on-one meetings, email, and regular interpersonal communication.
Provide oversight and direction to employees in accordance with PCI Pharma Services policies and procedures.