Sr. Manager Drug Product Development & Manufacturing with a global Biopharma company
* Located in San Francisco
* Competitive and Comprehensive Compensation Package
The Senior Manager will have the following Responsibilities:
* Act as SME and provide technical support for process development and scale up, technology transfer, process validation for several clinical programs in various phases at CDMOs
* Responsible for defining process characterization and process validation strategy, authoring of protocols and reports, executing studies, and analyzing data.
* Author and review process validation and manufacturing documentation including but not limited to protocols, batch records and SOPs.
* Work collaboratively and cross functionally externally with CMOs as well as with internal teams to review deviations, non-conformances, and assist with root cause analysis for investigations related to drug product manufacturing process and develop risk mitigation and CAPAs as required.
* Lead all activities for the full lifecycle of drug product process development and manufacturing
The Ideal Candidate will have the following skill set:
* Master's degree in a relevant field
* Required previous industry experience managing CMO relationships for drug product activities
* Expertise in drug product manufacturing with hands on experience in sterile filtration, aseptic processing, lyophilization, and media fill, vial and prefilled syringe fill.
* Experience with process scale-up of biologics programs to clinical or commercial manufacturing
* A deep understanding of relevant Good Manufacturing Practice (GMP), GMP systems, ICH guidelines and health authority regulations and expectations is required.
