**Hybrid Onsite Role, Alameda, CA**
Job opportunity with a top biopharmaceutical company that is looking for a Data Reviewer to join its team on a 12-month contract with a possibility for conversion or extension!
Qualifications:
- BS/BA degree in related discipline and a minimum of one year of related experience; or,
- MS/MA degree in related discipline and zero years of related experience; or,
- The biotech/Pharmaceutical Industry required
- Experience in an organic chemistry laboratory, process chemistry laboratory, or drug substance/API manufacturing setting is preferred
- Experience reviewing data, documents, notebooks, and worksheets generated in an organic chemistry laboratory, process chemistry laboratory, or drug substance/API manufacturing setting is preferred
- Must have knowledge of various types of analytical instrumentation and techniques used in an organic chemistry laboratory, process chemistry laboratory, or drug substance/API manufacturing setting.
Job Description/Skills:
- A review of executed batch records, master batch records, associated data, and manufacturing documents within the Exelixis Commercial Drug Substance Manufacturing Group and related Contract Manufacturing Organizations (CMOs) for accuracy and completion, and to ensure the work performed is in compliance with applicable procedures related to manufacturing of commercial drug substance/API
- Review documentation related to routine commercial manufacturing of raw materials, intermediates, and commercial drug substance/API, and gather and collect data pertaining to manufacturing process parameters
- Review protocols, change controls, and reports related to process validations and/or equipment and material qualifications.
Benefits/Perks:
- 401k
- Health Insurance
Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?
