Senior Pharma CMC & Tech Transfer Architect

Varda Space Industries; El Segundo (CA); On-site; USD 187,000 - 239,000; Full time

Job summary

Varda Space Industries in El Segundo, CA seeks a highly seasoned Principal Engineer, Pharma CMC Manufacturing & Tech Transfer to lead process transfer, CDMO qualification, pilot scale manufacturing, and GMP oversight for our crystallization and drug product pipeline. Reporting to the VP, CMC, this role builds the network of external partners and scales from lab to validated manufacturing packages.

You will collaborate with Pharma R&D, Quality & Regulatory, and external CDMO partners to stand up

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 for CMC manufacturing and tech transfer
• Experience managing external CDMO/CMO relationships, including technical oversight and contract negotiation

Responsibilities

• Own technology transfer execution: translate R&D developed processes into robust, CDMO-ready transfer packages
• Lead pilot plant production of material to support nonclinical development
• Lead selection, qualification, and ongoing management of CDMO partners across the manufacturing network
• Lead tech transfer of drug product fill-finish processes for the crystalline suspension
• Negotiate and manage Manufacturing Services Agreements with CDMO partners

Skills

CMC leadership

Technology transfer

CDMO management

Regulatory knowledge

Education

B.S./M.S. in life sciences or chemical engineering

Job description

Varda Space Industries in El Segundo, CA seeks a highly seasoned Principal Engineer, Pharma CMC Manufacturing & Tech Transfer to lead process transfer, CDMO qualification, pilot scale manufacturing, and GMP oversight for our crystallization and drug product pipeline. Reporting to the VP, CMC, this role builds the network of external partners and scales from lab to validated manufacturing packages.

You will collaborate with Pharma R&D, Quality & Regulatory, and external CDMO partners to stand up