Supervisor, Drug Product Manufacturing - 2nd Shift
About The Position
The Drug Product Manufacturing Supervisor is responsible for the implementation of all production and manufacturing procedures to optimize processes and ensure regulatory compliance. This position coordinates with other departments to plan, schedule, and execute all aspects of production operations in a validated cGMP environment. The schedule is generally 2:00 PM - 10:30 PM, and the role is eligible for a 10% differential when working 2nd shift hours. This role oversees daily operations including formulation, filtration, filling, and troubleshooting complex fill-finish equipment systems. It involves authoring and reviewing batch records, executing strategic planning with drug product manufacturing and other internal teams, and participating in client interactions and internal investigations. The supervisor also supports facility planning and provides audit responses. The role requires regular and reliable attendance on a full-time basis and exhibiting professional behavior. The supervisor must embody PCI Pharma Services' cultural values and align daily actions with department goals and company culture, while fostering a safe and environmentally sustainable workplace.
Requirements
- Bachelor’s degree in life sciences discipline or equivalent required
- Minimum of five (5) years of experience in relevant technical experience
- Minimum of 1 year leadership experience.
- Understanding of cGMP's.
- Understanding of regulatory requirements.
- Solid command of chemistry.
- Understanding of fillers and processes regarding filling.
- Understanding of QAD, ACE, LIMS, and RAM.
Responsibilities
- Oversee daily operations, including formulation, filtration, filling, and troubleshooting issues with complex fill-finish equipment systems.
- Author and review batch records and ensure compliance with applicable GMP processes.
- Execute strategic planning with drug product manufacturing and other internal teams, including defining schedules, coordinating preparation activities, and troubleshooting issues that arise.
- Participate in client calls, interactions, and meetings including kick-off meetings, facility tours, and resolving operational or quality issues.
- Participate in internal investigations, including deviations, corrective actions, preventative actions, and product quality reviews.
- Support facility planning for shutdowns, maintenance, HEPA certifications, qualifications, and media fill planning.
- Provide audit responses related to client, QP, and regulatory inspections, as well as SOP and Batch record revisions.
- Collaborate with the Quality team regarding EM investigations, OOS investigations, and deviation investigations.
- 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, engages and develops the team, including overseeing new employee onboarding and providing career development 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.
Benefits
- paid time off
- health insurance coverage (including dental and vision)
- a flexible spending account
- a 401(k) plan
- Eligible for 10% differential when working 2nd shift hours.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
