Principal Engineer, Pharma CMC Manufacturing & Tech Transfer
Core
Lead process transfer, CDMO qualification, pilot scale manufacturing, and GMP manufacturing oversight for Varda's crystallization and drug product pipeline.
Role type
Principal Engineer, Pharma CMC Manufacturing & Tech Transfer
Builds
Validated, transferable manufacturing packages executed across a network of external CDMO partners
Domain
Pharmaceutical manufacturing, CMC, Technology Transfer, Space infrastructure
Required skills
CMC manufacturing leadership, technology transfer execution, CDMO partner management, GMP compliance, regulatory filing coordination, budget management, cross-functional leadership
Preferred skills
Small molecule/biologics crystallization, high-concentration suspension drug products, aseptic fill-finish operations, aerospace regulatory environment (AS9100)
Technologies
cGMP, FDA guidelines, Manufacturing Services Agreements, comparability protocols
Responsibilities
Own technology transfer execution from R&D to CDMO-ready packages; Lead pilot plant production for nonclinical development; Select and qualify CDMO partners; Negotiate Manufacturing Services Agreements; Establish CDMO oversight and chain of custody; Lead engineering run execution and acceptance at CDMO sites; Oversee GMP manufacturing campaigns through batch release; Manage CDMO timelines and budget; Partner with Quality & Regulatory on control strategy and regulatory filings.
Seniority
Principal, hands-on IC with strategic oversight