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Sr Scientist Analytical Chemistry & QC - San Francisco Bay Area, California
Job Description
Requirements:
PhD (Chem Eng, Biochem, Chem etc) strongly preferred. Other degrees considered if direct work experience is strong.
> 6 years working in a Quality Control role in a pharmaceutical company or a CMO / CRO with experience in vendor management and validation transfer.
Work experience in a Quality Control or Analytical Chemistry position that was at least partially hands on laboratory based.
Small molecule experience required. Additional biologics experience nice to have.
Work experience in a GMP / GLP compliant environment with controlled systems and documents
Work setting up new control systems / standard operation procedures in a laboratory for drug substance and product
Experience with deviations and CAPA
Small molecule analytical skills. Additional biologics analytical chemistry skills also helpful.
Understanding of methods validation
Prior experience writing the analytical / QC / CMC sections of regulatory submissions (BLA/ NDA/ or MAA or INDs)
Excellent communication both verbally and written
Able and willing to spend 30% of time in laboratory as an individual contributor
Able to travel globally up to 10%
Description:
Help finalize Quality Control procedures / SOPs for data, equipment, inventory, and procedures for GLP testing
Manage methods validation, tests, and drug release at CMOs and CROs
Core part of CMC team responsible for ensuring analytical testing Quality Control testing is up to par depending on the phase of the program
Responsible for review of CMO and CRO generated data (for stability, validation etc.)
Develop controls for analytical testing for clinical programs
Author technical reports as part of method development, transfer, stability studies, etc.
Review stability data and batch records for both substance and product
Help with CAPA and out of spec investigations
Contribute to CMC parts of regulatory submissions
Technical support of analytical references to support manufacturing and design stability program
1221
Kathy Norris
650-632-5027
knorris@jgbbiopharma.com
Connect with me on LinkedIn: https://www.linkedin.com/in/kathy-norris-cir-b1877ab/
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JGB BioPharma
Connecting companies with qualified talent in biopharmaceutical, medical device, diagnostics, bioinformatics and medical/high tech blended industries.
JGB BioPharma provides full time placement and consulting services in all areas of development such as project management, clinical operations & science, biometrics, technical/medical Writing, quality, CMC, and regulatory.
Check our JOB OPENINGS at: www.jgbbiopharma.com/jobs