Supervisor, Drug Product Manufacturing - 2nd Shift

PCI Pharma Services • San Diego, CA

1d • $85,120 - $95,760

About The Position

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Drug Product Manufacturing Supervisor is responsible for the implementation of all production and manufacturing procedures to optimize processes and regulatory requirements. This position coordinates with other departments to plan, schedule, and execute all aspects of production operations in a validated cGMP environment. This position would be for 2nd Shift: 3:00PM – 11:30PM Eligible for 2nd shift 10% pay differential

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 (formulation, filtration, filling and troubleshooting of any issues with complex fill finish equipment systems.
• Batch Record authoring and reviewing applicable GMP processes.
• Strategic planning with drug product manufacturing and other internal teams including defining schedule, coordinating preparation, and troubleshooting any issues that may arise.
• Participate in client calls, interactions and meetings including kick-off meetings, tours, and resolving operational or quality issues.
• Participate in internal investigations including deviations, corrective actions, preventative actions, and product quality reviews.
• Facility planning for shutdowns, maintenance, HEPA certifications, qualifications and media fill planning.
• Provide audit responses related to Client, QP, and Regulatory Inspections, SOP and Batch record revisions.
• Interact with the Quality team regarding EM investigations, OOS investigations, and 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.
• 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, 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

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level