What are the responsibilities and job description for the High Potency API Production Manager position at Coda Search│Staffing?
Job Description:
The High Potency API Lead will be responsible for the manufacturing of highly potent API pharmaceuticals in kilogram-scale lab. This role requires strong leadership and technical skills to ensure that all products meet customer and internal specifications.
Responsibilities:
- Execute Quality and Safety inspections, trainings, and programs for the Production group.
- Translate objectives to Production by collaborating with SMEs in Safety, Quality, Maintenance, Training, etc.
- Complete batch records in accordance with FDA and Current Good Manufacturing Practices (cGMP) guidelines.
- Provide process support and troubleshooting necessary to meet all customer requirements.
Requirements:
- High School Diploma with 5-10 years of experience in highly potent API Manufacturing or equivalent.
- Solid understanding of GMP and FDA regulations.
- Excellent communication and safety awareness skills.
- Ability to independently apply scientific and/or technical knowledge in the performance of job duties.
Additional Requirements:
- Must be able to lift 50lbs.
- Must be willing to work a rotating shift.
