About This RoleOur CMC team is looking for a highly motivated and experienced Principal Engineer, Pharma CMC Manufacturing & Tech Transfer to lead process transfer, CDMO qualification, pilot scale manufacturing, and GMP manufacturing oversight for Varda's crystallization and drug product pipeline. Reporting to the VP, CMC, this role owns the path from a lab-characterized process to a validated, transferable manufacturing package executed reliably across a network of external partners. This position requires close collaboration with Pharma R&D, Quality & Regulatory, and external CDMO partners to stand up and run the manufacturing network.
This is an opportunity to build a CMC manufacturing function from the ground up - selecting and qualifying CDMO partners, executing technology transfer, running engineering & pilot scale batches, and ultimately delivering GMP clinical material - while helping shape how Varda's terrestrial and orbital manufacturing strategies come together.
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 (Crystallization, Fill-Finish, and DS Partner), including RFPs, technical due diligence, and capability assessments
- Lead tech transfer of drug product fill-finish processes for the crystalline suspension, partnering with R&D on process- and product-specific technology 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 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 budget; report progress regularly 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 tech transfer
Basic 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
Preferred Skills and Experience - 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) is a plus
Pay Range
- Salary range: $187,000 - $239,000/per year
- This role is on-sitein El Segundo, CA
- Leveling and base salary is determined by job-related skills, education level, experience level, and job performance
- You will be eligible for long-term incentives in the form of stock options and/or long-term cash awards
ITAR RequirementsVarda, like all employers, must ensure that its employees working in the United States are lawfully authorized to work in the U.S. Additionally, our employees are exposed to and have access to certain export-controlled items. Because our employees are provided access to export-controlled items, our policy is to only hire "U.S. persons" who are permitted to have access to our technology without an export license.
"US person" means: U.S. citizen, U.S. lawful permanent resident, or protected individual as defined by 8 U.S.C. 1324b(a)(3) (i.e., individual admitted to the U.S. as a refugee or granted asylum).
