An amazing opportunity has just become available within a growing biologics company located in South San Francisco. The Director of CMC will lead the development and manufacturing efforts to advance the pre-clinical and clinical pipeline focused on antibody therapeutics.
We are partnering with a small, pre-IPO company in the oncology field that is rapidly expanding. This role will be responsible for working collaboratively with clinical, regulatory, quality, and process development teams to lead product development and manufacturing activities in-house and with external vendors.
• Establish strategies for process development and manufacturing to support preclinical and clinical programs
• Prepare and review RFPs and quotes for CSP activities
• Serve as an interface with CSPs and manage outsourced manufacturing, QC, and process development activities
• Write and review CMC regulatory sections for IND/INDa
• Coordinate technical reviews and approvals of Master Batch Records and ensure proper documentation for manufacturing and process development activities
• Support cell line development, upstream and downstream development, QC, analytical assays, and process validation
• Master’s or PhD in biochemistry, chemical engineering, or related field
• 8+ years of experience in early and late stage biologic development, cGMP manufacturing, and process validation
• Experience writing and review CMC sections for regulatory submissions
• Experience in analytical methods development and validation
• Familiar with analytical and biologics development strategies
The full job description and company details are available upon application. This position is being handled by Sara at Meet, call +1 650-763-2376 or email directly at firstname.lastname@example.org to discuss further and in confidence.
You can find more about Sara and Meet online at www.peoplewithchemistry.com