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.
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.