Senior Manager CMC Cell Culture Manufacturing

We are partnered with a growing biotech organization that is seeking a Senior Manager of Upstream Manufacturing. This role is focused on leading cell culture manufacturing oversight across a network of CDMOs. They will represent the upstream 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, ideally be based on the West Coast, and travel to vendors as needed.

Responsibilities:

• Provide technical oversight and guidance for upstream manufacturing to CDMO teams, fostering strong working relationships and supporting manufacturing operations
• Troubleshoot and evaluate manufacturing processes, parameters, and specifications to ensure product quality and consistency
• Manage internal quality systems including change controls, deviations, CAPAs, and review of batch records and trends (OOT/OOS)
• Author and review technical documentation such as protocols, reports, tech transfer docs, risk assessments, and regulatory filings
• Communicate complex CMC manufacturing issues clearly across teams and contribute to CDMO selection and evaluation processes.

Requirements:

• A PhD, MS, or even a BS in Chemical Engineering, Bioengineering, Biochemistry, Biology or a relevant discipline and at least 8 years of industry experience in upstream process development of antibody-based therapeutics. MS or BS will require more years of industry experience.
• Experienced in leading late stage activities including PPQ, process validation, and process transfer activities with CDMOs for cell culture manufacturing
• Success in authoring upstream sections of BLA/MAA submissions
• Demonstrated expertise in influencing positive vendor relationships, acting as person-in-plant when needed, and proactively prioritizing activities to lead to successful upstream manufacturing

Contact:

Please reach out to Amit at amit.uma@meetlifesciences.com to have a confidential chat about the role.