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Senior Manager CMC Analytical Development

San Jose, CA · Biotech/Pharmaceutical
Title: Senior Manager CMC Analytical Development
Location: San Jose, CA
Relocation Assistance: Yes

The candidate in this position will play a pivotal role in our R&D Department working on novel projects involving drug-device combinations for treating chronic diseases with the potential to dramatically impact patient outcomes.

Requirements
  • Comprehensive knowledge of state-of-the-art analytical techniques such as various HPLC modes and detections, LC-MS, CE-SDS, peptide mapping, ELISA, cell-based assays, etc., for product characterization, comparability testing and PK/PD analyses.
  • Hands on experience in stage appropriate method validation and specification setting.
  • Assessing chemical and physical stability of formulations and identifying appropriate stability, manufacturability, and performance critical quality attributes.
  • Proven expertise in establishing and managing reference standard and stability programs.
  • Experience in protein purification and biologic formulation is a plus.
  • Participate in method and tech transfer from R&D to Manufacturing as appropriate.
  • Experience in writing, reviewing and approving CMC sections of regulatory filings.
  • Good working knowledge of GMP requirements, including ICH, FDA, and EMA guidelines, for development and manufacturing of drug products and/or drug-device combination products (a plus).
  • Assessing utilization of resources and identifying when, and where additional resources may be needed.
  • Must be able to work in a fast paced, changing environment with demonstrated ability to manage multiple competing responsibilities with a high degree of self-motivation.
  • A track record in collaboration with cross functions, including (but not limited to) Process/Engineering Development, Formulation/Drug Product Development, Manufacturing, Quality Assurance, and Regulatory Affairs, is required.
  • To communicate effectively to the project team and present data at team meetings.
  • To maintain high quality documentation of all activities in notebooks, reports as required.
  • Keep up to date with relevant scientific and technical developments.

Education and/or Job Experience
  • B.S./M.S. or advanced degree (preferred) in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering or related fields.
  • Must have 5+ years of relevant pharmaceutical or biotechnology development experience.
  • Position and compensation will be commensurate with experience.
  • A track record in biologics analytical development, particularly, experience in biophysical techniques and analytical characterization of peptides and proteins is a must.
  • Working knowledge in product formulation (solid oral dosage, and/or parenteral sustained release) and process development from early to late phase development or at minimum hands on experience in providing analytical support to these activities.
  • Experience of working in GLP/GMP regulated environment.
  • Experience in working with drug-device combination products is a plus.
  • Excellent oral and written communication skills.
  • The ability to work as a member of a multidisciplinary team.

Thank you for your interest in the Senior Manager CMC Analytical Development position. A brief cover letter outlining your relevant experience is kindly requested. Applicants that meet the client’s qualifications will be contacted; all other candidates will be retained for future opportunities.



 
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