What are the responsibilities and job description for the API Chemist position at Benuvia?
API Manufacturing Chemist is responsible for a cGMP, bulk chemical, manufacturing facility to perform manufacturing and process development responsibilities related to the production of Active Pharmaceutical Ingredients (API).
Reports to the Director of Manufacturing. This position will have direct oversight of API Manufacturing Technicians. They will also have interactions with other departments including Quality Control, Quality Assurance, Analytical / Stability, Validation, and Research & Development.
DUTIES AND RESPONSIBILITIES
- Maintain production duties as scheduled by API Manufacturing Supervisor.
- Lead production operations to meet scheduled timelines and goals for production.
- Oversees daily schedule and work tasks of technicians.
- Perform bulk organic synthesis and large-scale liquid chromatography.
- Perform in-process and finished product sampling.
- Perform in-process product analysis via HPLC in a cGMP regulated laboratory.
- Ensure equipment is maintained to minimize disruption to production schedules.
- Assist in troubleshooting equipment and processing problems which may arise.
- Report all issues and concerns to supervisor.
- Perform Installation Qualifications, Operational Qualifications, and Process Validations for cGMP equipment as necessary.
- Keep current on all required training and SOPs.
- Maintain / order inventory of raw materials, lab supplies, and solutions.
- Maintain a clean laboratory.
- Perform facility and equipment cGMP cleaning.
- Ensure proper cGMP documentation – maintain quality records and inventory databases.
- Write and submit deviations according to GMP guidelines.
- Assist in training of API Manufacturing Technicians
- Ensures safety protocols and policies are being followed.
- Reviews executed Mfg. Batch records for completeness, errors, and omissions before final review.
QUALIFICATIONS
WORKING CONDITIONS / PHYSICAL REQIUREMENTS
