Supervisor, Drug Product Manufacturing - 2nd Shift

PCI Pharma Services•San Diego, CA

6d•Onsite

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 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. It also involves coaching, mentoring, engaging, and developing the team, including overseeing new employee onboarding and providing career development planning and learning opportunities. The supervisor sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management, while maintaining transparent communication. Oversight and direction are provided to employees in accordance with PCI Pharma Services policies and procedures.

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.
Regular and reliable attendance on a full-time basis.
Exhibit 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.
Embody PCI Pharma Service’s cultural values and align daily actions with department goals and company culture.
Foster a safe and environmentally sustainable workplace by ensuring compliance with all PCI EHS policies and procedures.