The Senior Production Chemist will work on the production of synthetic chemical reagent products - dyes, nucleosides and intermediates, under cGMP environment for use in Cepheid in-vitro diagnostic products. Chemical reagent manufacturing includes manual methods as well as automated purification methods. Other general laboratory procedures also apply, including in-process and QC analytical techniques.
The position is an advanced technical role that includes performance of validation and maintenance activities of specialized production equipment. This requires preparation of validation protocols and writing final reports, as well as writing and revising procedures. Some process optimization work will be included in the job responsibilities, working closely with the Research & Development team as needed. Also , this person will be responsible for the maintenance of department production schedule, coordination of resources to meet target deadlines, and reporting plans and results to supervisor. This position serves as an experienced advisory role to production staff.
- Production of Reagents - dyes, nucleosides and intermediates needed for various products under cGMP compliance in large scale.
- Establishing procedures and records including SOPs, batch records and generation of labels.
- Hands-on characterization and purification of raw materials, intermediates and finished products using HPLC, LCMS and NMR techniques.
- Purification of dyes, quenchers, nucleosides and intermediates using crystallization techniques, and/or flash chromatography.
- Process optimization, auto purification (ISCO or Biotage System) and scale up of reagents (5L - 50L).
- Trouble shooting Manufacturing processes of reagents.
- Developing analytical protocols, specifications and SOPs for testing incoming raw materials and in process materials used in the manufacturing of proprietary. chemical reagents and intermediates.
- Maintenance of Production schedule and making sure that production is on target.
- Writing validation protocols or SOPs and Validation Reports for QC methods.
- Participate in Process Transfer activities.
- Work with QA to address any investigations and finding mitigations following CAPA procedure.
- Ensure and adhere to GMP compliance and maintain a clean/ traceable work environment.
- Additional responsibilities also include sustaining the production of solid supports (CPGs and polystyrenes for use Oligo synthesis) to comply with established SOPs.
- Bachelor's degree in Chemistry or related discipline with a minimum of 8-10 years experience; or, a Master's degree in Chemistry or related experience with a minimum of 4-6 years experience; or, Ph.D. with 3 years of direct related experience.
- Experience working with Chemisty in a cGMP manufacturing environment.
- Ability to follow established SOPs, Worksheets and Batch Records.
- Proficient and hands-on experience in analytical equipments, such as UV, NMR, HPLC and LCMS.
- Ability to create and draft new SOPs, Work sheets and protocols for general manufacturing processes, equipments etc.
- Ability to work under minimal supervision and in a timely manner to meet broad objectives.
- Ability to learn new skills and taking on new responsibilities.
- Excellent oral and written communication skills. Ability to communicate and present clearly, concisely and persuasively.
- Excellent training and awareness of Chemical Safety practices.
- Ability to multi-task and work in fast-paced environment.
- Strong desire to lead, manage, and mentor others.
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