Supervisor, Drug Product Manufacturing Formulations
PCI Pharma Services•San Diego, CA
•Onsite
About The Position
The Supervisor, Drug Product Manufacturing - Formulations manages the group responsible for all complex formulation manufacturing. This position is responsible for implementation of all production and manufacturing procedures to optimize formulation processes and regulatory requirements. The Supervisor, Drug Product Manufacturing - Formulations coordinates with other departments to plan, schedule, and execute all aspects of production operations related to complex formulations in a validated cGMP environment.
Requirements
- Bachelor's degree in a life science or equivalent preferred.
- Minimum of 5 years’ relevant technical experience
- Minimum of 1 year of leadership experience.
- Understanding of cGMP's, and regulatory requirements.
- Solid command of chemistry.
- Understanding of complex formulation equipment, technical aspects of the processes and formulations.
- Experience using ERP systems (preferably QAD) and EQM systems (preferably ACE).
- Experience with LIMS, and RAM.
Responsibilities
- Overseeing daily operations, including formulation activities and troubleshooting any issues that may arise
- Batch record review and generation, along with mixing studies
- Strategic planning with the Drug Product (DP) manufacturing team including defining the schedule coordinating preparation activates and troubleshooting any issues that may arise
- Participating in client calls, kick off meetings, tours, and resolving operational issues
- Oversee internal investigations including deviations, corrective actions, preventative actions and product quality reviews
- Facility planning for site shutdowns, maintenance and APV planning
- Provide audit responses related to Client, QP, Regulatory Inspections, SOPs and Batch Record revisions
- 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’s cultural values and aligns daily actions with department goals and company culture.
Benefits
- paid time off
- health insurance coverage (including dental and vision)
- flexible spending account
- 401(k)
- annual performance bonus
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1-10 employees
