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Salary: USD 187,000 - 239,000 / annual
Varda Space Industries is building commercial space infrastructure, including in-orbit pharmaceutical processing and reentry capsules. The company manufactures crystalline drug products in low Earth orbit and brings them back to Earth for terrestrial use, combining aerospace and pharmaceutical manufacturing expertise.
You will lead the Chemistry, Manufacturing, and Controls (CMC) function for Varda's pharmaceutical pipeline, reporting to the VP of CMC. This is a ground-floor opportunity to build a manufacturing organization from inception, owning the complete path from lab-characterized R&D processes to validated, GMP-compliant manufacturing executed through a network of external Contract Development and Manufacturing Organization (CDMO) partners.
Key responsibilities include:
- 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 Drug Substance partners), 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 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 of CMC and executive team
Varda is headquartered in El Segundo, California, with additional offices in Washington, DC and Huntsville, AL. The company was founded in 2021 by Will Bruey and Delian Asparouhov and is backed by top-tier investors including Khosla Ventures, Lux Capital, Founders Fund, and General Catalyst. The leadership and staff include veterans from SpaceX, Blue Origin, major pharmaceutical companies, and Silicon Valley.
REQUIREMENTS:
- 10+ years of pharmaceutical manufacturing experience, including process development, technology transfer, and GMP manufacturing
- 5+ years of direct CDMO management and oversight experience
- Deep expertise in small-molecule drug product manufacturing, including crystallization, formulation, and fill-finish processes
- Demonstrated experience leading cross-functional teams (R&D, Quality, Regulatory, Operations) in a fast-paced, regulated environment
- Strong project management and timeline/budget ownership skills
- Experience with regulatory submissions (IND, CTA, BLA) and FDA interactions
- Knowledge of ICH Q7, ICH Q11, and GMP regulations
- Experience in an aerospace regulatory environment (e.g., AS9100) is a plus
ITAR REQUIREMENT: This role requires access to export-controlled items. Only "US persons" may be hired: U.S. citizens, U.S. lawful permanent residents, or individuals admitted to the U.S. as refugees or granted asylum.
