San FranciscoFull TimeEngineering
Remotely
quality controlcmcveeva vaultanalytical developmentcgmpuspjmpich guidelines
Job Description
📋 Description
- Management of contract drug substance and drug product analytical development and quality control
- Authoring and review of analytical method transfer and validation protocols and reports
- Direct batch release support by reviewing and approving sampling plans and analytical data
- Review stability protocols and monitor various stability programs
- Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings
- Partner with QA to manage change controls; lead OOS/OOT and deviation investigations to identify
🎯 Requirements
- At least 10 years of experience in Analytical Development and/or Quality Control in a
- Familiarity with CMC analytical regulatory requirements and authoring of IND/IMPD/BLA/NDA/MAA
- Independently proficient in a variety of analytical techniques in support of biologic and small
- Ability to communicate effectively with vendors regarding project scope, scientific results and
- Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices.
- Subject matter expertise in stability program management, including protocol design, data trending
🎁 Benefits
- Market-leading compensation
- 401(k) with employer match
- Employee Stock Purchase Program (ESPP)
- Pre-tax commuter benefits (transit and parking)
- Referral bonus for hired candidates
- Subsidized lunch and parking on in-office days
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