EmployBridge Search Group
is currently conducting a search for a Manufacturing Manager in the San Diego, CA area. The Manufacturing Manager will be responsible for overseeing manufacturing, regulatory, research, and development in a pharma contract manufacturer. The Manufacturing Manager will be responsible for overseeing the development of compounds from early-stage research to clinical trials required for regulatory approvals, manufacturing contract prescriptions, and OTC pharmaceuticals. The Manufacturing Manager is responsible for driving quality, efficiency, and leading the expansion in the manufacturing department.
- Coordination and leading of all departments to complete scale-up, validation, launch, and routine manufacturing of oral dosage forms and sterile products
- Product and process validation protocol development, execution, and reporting
- Developing and maintaining cleaning validation protocol development, execution, and reporting
- New equipment IQ/OQ/PQ (protocol development, execution, reporting)
- Oversight of creating and maintaining production schedules with manufacturing supervisors.
- Training, scheduling, and supervision of Manufacturing Supervisors
- Oversight of Manufacturing Supervisors in the final review of batch documentation
- Oversee proper maintenance of all manufacturing equipment within the facility
- Oversee inventory control procedures and processes
- Coordination with the appropriate department to ensure outside suppliers and consultants meet scheduled deadlines.
- Development, implementation, and effectiveness of the Quality Management System per cGMP
- Pricing and establishing feasibility for new business opportunities including new product cost analysis
- Bachelor’s degree required in Chemistry, Biochemistry, Manufacturing Engineering, or related scientific field. Advanced degree preferred.
- 5 plus years leading a GMP manufacturing environment
- 2 plus years of project management experience is desired.
- Experience in drug development, clinical trial material manufacturing, and/or commercial drug product manufacturing is preferred.
- Experience in capacity modeling, process mapping, lean manufacturing, and Six Sigma, and value stream mapping
- Manufacturing-based technology, processes, and knowledge of Environmental Health and Safety practices is preferred
- Ability to drive quality, efficiency, and leading company expansion.
- Strong leadership ability.
- Excellent communication skills, both written and verbal.