Manager, Drug Product Manufacturing

PCI Pharma Services•San Diego, CA

2d•Onsite

About The Position

This position is responsible for managing the day-to-day activities of fill & finish manufacturing. This position is responsible for implementation of all production and manufacturing equipment and procedures to optimize processes and regulatory requirements. The Manager coordinates with other departments to plan, schedule, and execute all aspects of production operations in a validated cGMP environment.

Requirements

Bachelor’s degree in scientific discipline or equivalent experience required.
Minimum of seven (7) years of related technical experience.
Minimum of three (3) year of leadership/supervisory experience.
Understanding of cGMP's.
Understanding of regulatory requirements.
Solid command of chemistry including understanding of fillers and processes regarding filling.
Understanding of QAD, Master Control, LIMS, and RAM.

Responsibilities

Oversees daily operations including formulation, filtration, filling and troubleshooting any issues.
Batch record review and generation (Client calls and Project Management interactions)
Strategic planning with DP manufacturing including defining the schedule, coordinating preparation, and troubleshooting.
Client calls, interactions and meetings (kick off meeting, tours, and operational issues).
Internal investigations (Deviations, Corrective Actions, Preventative Action, Product Quality reviews).
Facility planning (Shutdowns, maintenance, HEPA certifications, and media fill planning).
Audit Responses (Client, QP, and Regulatory Inspections, SOP and Batch record revisions).
Quality interactions (EM investigations, OOS investigations, Deviation Investigations).
Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Proactively assumes responsibility that assignments are executed properly, attaining desired outcomes on schedule and meets quality standards.
Builds and establishes sound working relationships with internal departments and external clients in support of company goals.
Supports, encourages, and collaborates with others, especially in difficult and high-pressure situations.
Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.
Directs and provides expert knowledge in the day-to-day function of Drug Product Manufacturing.
Identifies, recruits, and retains top-notch talent.
Champions PCI Pharma Services culture and empowers employees to take responsibility for their jobs and goals.
Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development and planning and learning opportunities.
Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
Maintains transparent communication.
Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication.
Provides oversight and direction to the employees in accordance with PCI Pharma Services policies and procedures.