Principal Engineer, Pharma CMC Manufacturing & Tech Transfer

The role

This person will lead process transfer, CDMO qualification, pilot scale manufacturing, and GMP manufacturing oversight for crystallization and drug product pipelines. They will own the path from lab-characterized processes to validated manufacturing packages executed via external partners.

What you will do

• Own technology transfer execution
• Lead pilot plant production of material to support nonclinical development
• Lead selection, qualification, and management of CDMO partners
• Lead tech transfer of drug product fill-finish processes
• Negotiate and manage Manufacturing Services Agreements with CDMO partners
• Establish the CDMO oversight model
• Lead engineering run execution and acceptance at CDMO sites
• Build and lead an internal Manufacturing Sciences & Technology function
• Oversee GMP manufacturing campaigns through batch release
• Manage CDMO manufacturing timelines and budget

Required qualifications

• 10+ years of CMC manufacturing and/or technology transfer leadership experience advancing drug product development programs to successful clinical trials
• B.S. or M.S. in life sciences, chemical engineering, or related field
• Firm understanding of cGMP and FDA regulatory guidelines as they pertain to CMC manufacturing and tech transfer
• Demonstrated experience managing external CDMO/CMO relationships, including technical oversight and contract negotiation

Nice to have

• 13+ years of CMC manufacturing leadership experience, including direct responsibility for process transfer and CDMO network management
• Experience with small molecule and/or biologics crystallization processes and/or high-concentration suspension drug products
• Hands-on experience standing up a CDMO network from selection through GMP manufacturing for an early-stage or growth-stage biotech/pharma company
• Experience with aseptic fill-finish operations and engineering/media fill run execution
• Advanced understanding of cGMP and FDA regulations and guidance relating to CMC manufacturing and comparability
• Excellent leadership, managerial, and communication skills in a cross-functional, multi-site environment
• Experience in an aerospace regulatory environment (e.g., AS9100)

Benefits

• Stock options
• Long-term cash awards

Before you apply

• Must be a U.S. person (U.S. citizen, U.S. lawful permanent resident, or protected individual)
• Employees are exposed to and have access to certain export-controlled items

About the company

Varda is accelerating the development of commercial space infrastructure, from in-orbit pharmaceutical processing to reliable and economical reentry capsules. The company is headquartered in El Segundo, California.