We are partnered with a growing biotech organization that is seeking a Bay Area-based Senior Manager of CMC Drug Product Development. This role is focused on leading drug product manufacturing across their network of CDMOs. They will also represent the drug product function internally and externally. This is a great opportunity for someone who is interested in creating therapeutics for serious autoimmune and cancer indications, which are in clinical trials. The ideal candidate will work remotely out of the Bay Area with expected travel.

Responsibilities:

• Provide technical oversight and troubleshoot with CDMOs to ensure successful investigational product manufacturing.
• Review and evaluate process parameters, specifications, batch data, records, and trends, including addressing OOT/OOS issues.
• Author and review technical documents such as protocols, reports, risk assessments, and regulatory filings.
• Participate in identifying and selecting CDMOs and representing CMC Manufacturing in process teams.
• Translate technical manufacturing issues for broader audiences and support technical transfer processes.

Requirements:

• A Ph.D. in Chemical Engineering, Bioengineering, Biology, Protein Chemistry, Biochemistry or a related field with 6+ years of biopharmaceutical industry experience across biologics drug product development. An MS or BS with relevant experience may also be considered.
• Hands-on expertise in manufacturing unit operations, including validation of DP filling lines and processes
• Proven experience in cGMP manufacturing, CDMO/vendor management, and regulatory submissions.
• Strong problem-solving, project management, and communication skills with cross-functional and global teams.
• Proficiency in Microsoft Office, data analysis, and adaptability to fast-paced, competing priorities; travel required for PIP activities.

Contact:

For a confidential discussion, please reach out to Amit at or 628 336 2772.