Principal Engineer, Pharma CMC Manufacturing & Tech Transfer

Varda Space Industries•El Segundo, CA

18d•$187,000 - $239,000•Onsite

About The Position

Varda’s CMC team is seeking a highly motivated and experienced Principal Engineer to lead process transfer, CDMO qualification, pilot-scale manufacturing, and GMP manufacturing oversight for its crystallization and drug product pipeline. Reporting to the VP, CMC, the role owns the path from a lab-characterized process to a validated, transferable manufacturing package that can be reliably executed across external partners. The position works closely with Pharma R&D, Quality & Regulatory, and CDMO partners to establish and operate the manufacturing network. The role will build Varda’s CMC manufacturing function, including selecting and qualifying CDMO partners, executing technology transfers, running engineering and pilot-scale batches, and delivering GMP clinical material. It will also help shape how Varda’s terrestrial and orbital manufacturing strategies come together. The position is on-site in El Segundo, California.

Requirements

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 a related field.
Firm understanding of cGMP and FDA regulatory guidelines as they pertain to CMC manufacturing and technology transfer.
Demonstrated experience managing external CDMO/CMO relationships, including technical oversight and contract negotiation.

Nice To Haves

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 establishing 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).

Responsibilities

Own technology transfer execution by translating 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 crystallization, fill-finish, and drug substance partner network, including RFPs, technical due diligence, and capability assessments.
Lead technology transfer of drug product fill-finish processes for the crystalline suspension, partnering with R&D on process- and product-specific transfer coordination.
Negotiate and manage Manufacturing Services Agreements with CDMO partners, defining scope, key terms, and deliverables in partnership with Legal and Quality.
Establish the CDMO oversight model, including a defined chain of custody across CDMO handoffs.
Lead engineering-run execution and acceptance at CDMO sites, including comparability protocols confirming CDMO-produced material matches Varda-characterized material.
As volumes increase, build and lead an internal Manufacturing Sciences & Technology (MS&T) function to support process transfer, engineering runs, and GMP manufacturing oversight.
Oversee GMP manufacturing campaigns through batch release, partnering with Quality on batch-record review, change control, deviation management, and release-testing coordination.
Manage CDMO manufacturing timelines and budgets, and regularly report progress to the VP, CMC and executive team.
Partner with Quality & Regulatory on control strategy, release specifications, and CMC sections of regulatory filings related to manufacturing and technology transfer.