The Manufacturing Chemist is responsible for the manufacturing of Cepheid proprietary chemical reagents in large scale under GMP compliance. The successful candidate will have demonstrated knowledge of chemistry and laboratory techniques.
- Performs multi-step synthetic sequences to manufacture proprietary dyes, quenchers, solid supports, and intermediates using large-scale reaction equipment. Purifies the products using crystallization techniques, manual or automatic chromatography.
- Follows established production procedures and protocols and records manufacturing activities to the Batch Records in real time.
- Analyzes manufactured compounds using HPLC, LCMS, NMR, FTIR techniques.
- Uses company ERP system to handle material transfers and activity confirmations.
- Conducts manufacturing activity in strict accordance with GMP regulations, Company quality policy, and safety requirements. Maintain clean workstation and traceable records.
- Subordinates to the Chemistry Manufacturing manager or designee.
- BS in Chemistry or related discipline; or equivalent combination of education and experience to perform at this level.
- A minimum of 3 years of related experience in Chemistry of Biotechnology manufacturing.
- Ability to perform chemical processes in 5-50-L scale.
- Ability to follow established manufacturing SOPs and record activities to Batch Record.
- Hands-on experience in analytical techniques and equipment (HPLC, NMR, LCMS).
- Ability to work under GMP requirements and maintain clean working environment and traceable documentation.
- Ability to perform manufacturing activities in safe manner and under minimal daily supervision.
- Good oral and written communication skills.