Manager, Drug Product Manufacturing - 2nd Shift

PCI Pharma Services•San Diego, CA

2d•$106,800 - $120,150

About The Position

The Manager, Drug Product Manufacturing is responsible for managing day-to-day fill-and-finish manufacturing activities and implementing production processes, manufacturing 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 position oversees formulation, filtration, filling, troubleshooting, batch records, production planning, client interactions, investigations, facility planning, audit responses, and quality matters. It also provides leadership for the Drug Product Manufacturing team, including hiring, coaching, employee development, performance management, communication, and oversight in accordance with company policies. This is a second-shift role, generally starting at 2:00 PM, with eligibility for a 10% pay differential for hours worked on second shift. The hiring rate is $106,800–$120,150, plus eligibility for an annual performance bonus. The role is based in Lusk.

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.
Understanding of 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, including client calls and project management interactions.
Plan Drug Product Manufacturing operations, define schedules, coordinate preparation, and troubleshoot production 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 activities, including shutdowns, maintenance, HEPA certifications, and media fills.
Prepare and respond to client and regulatory audits and inspections, and revise SOPs and batch records as needed.
Coordinate quality interactions, including environmental monitoring, out-of-specification, and deviation investigations.
Maintain regular and reliable full-time attendance or attendance in accordance with the posted schedule.
Exhibit professional behavior with internal and external business associates consistent with company policies and practices.
Ensure assignments are properly executed, achieve desired outcomes on schedule, and meet quality standards.
Build and maintain effective working relationships with internal departments and external clients.
Collaborate with and support others, especially in difficult and high-pressure situations.
Align daily actions with PCI Pharma Services cultural values and department goals.
Promote a safe and environmentally sustainable workplace by ensuring compliance with EHS policies and procedures.
Direct and provide expert knowledge in the day-to-day function of Drug Product Manufacturing.
Identify, recruit, and retain qualified employees.
Champion company culture and empower employees to take responsibility for their work and goals.
Coach, mentor, engage, and develop team members, including onboarding and career development planning.
Set performance standards and support 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 company policies and procedures.