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

About the role

This position is responsible for managing the day-to-day activities of fill & finish manufacturing. It involves implementing all production and manufacturing equipment and procedures to optimize processes and meet regulatory requirements. The role also includes coordinating with other departments to plan, schedule, and execute all aspects of production operations in a validated cGMP environment.

Responsibilities

• Oversees daily operations including formulation, filtration, filling, and troubleshooting any issues.
• Batches record review and generation (Client calls and Project Management interactions).
• Strategic planning with DP manufacturing including defining the schedule, coordinating preparation, and troubleshooting.
• Supports client calls, interactions, and meetings (kick off meeting, tours, and operational issues).
• Engages in internal investigations (Deviations, Corrective Actions, Preventative Action, Product Quality reviews).
• Facilitates facility planning (Shutdowns, maintenance, HEPA certifications, and media fill planning).
• Responds to audit requests (Client, QP, and Regulatory Inspections, SOP and Batch record revisions).
• Collaborates on quality interactions (EM investigations, OOS investigations, Deviation Investigations).
• Ensures regular and reliable attendance on a full-time basis.
• Exhibits 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.
• 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.
• Embraces 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.
• Recruits and retains top-notch talent.
• Champions PCI Pharma Services culture and empowers employees to take responsibility for their jobs and goals.
• Engages in coaching, mentoring, and developing 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 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.

Qualifications

• Required Bachelor’s degree in scientific discipline or equivalent experience required.
• Minimum of seven (7) years of related technical experience.
• Minimum of three (3) years 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.

Pay

The hiring rate for this position is $106,800 - $120,150 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise.

Benefits

PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.