Principal Engineer, Pharma CMC Manufacturing & Tech Transfer

vardaspace; El Segundo (CA); Vor Ort; USD 190.000 - 280.000; Vollzeit

Zusammenfassung

Varda in El Segundo, CA seeks a Principal Engineer, Pharma CMC Manufacturing & Tech Transfer to lead process transfer, CDMO qualification, and GMP manufacturing oversight for the crystallization and drug product pipeline. Reporting to the VP, CMC, this role builds the network to transfer lab processes into validated manufacturing packages with external partners.

You will select and qualify CDMO partners, execute tech transfer, run pilot scale batches, and help shape Varda's strategic

Qualifikationen

• 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

Aufgaben

• 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)
• 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

Kenntnisse

CMC leadership

Tech transfer

CDMO management

GMP compliance

Ausbildung

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

Jobbeschreibung

About Varda

Low Earth orbit is open for business. Varda is accelerating the development of commercial space infrastructure, from in-orbit pharmaceutical processing to reliable and economical reentry capsules. Varda's W-Series vehicles are built, designed, and operated by Varda in-house, including the pharmaceutical processing payloads, the capsules, the C-PICA heat shields, and the satellite buses.

From life-saving pharmaceuticals to more powerful fiber optics, there is a world of products used on Earth today that can only be manufactured in space. Varda is accelerating innovation in the orbital economy by creating both the products and infrastructure needed so space can directly benefit life on Earth. Our mission is to expand the economic bounds of humankind.

Our team is uniquely suited to accomplishing this goal, with leadership and staff comprised of veterans from SpaceX, Blue Origin, major pharmaceutical companies and Silicon Valley. Varda was founded in January 2021 by Will Bruey and Delian Asparouhov with significant backing from world class investors including Khosla Ventures, Lux Capital, Founders Fund, Caffeinated Capital, General Catalyst, and Also Capital.

Varda is headquartered in El Segundo, California, where we have offices and a production facility where our vehicles, equipment, and materials are built, integrated, and tested. Varda also has offices in Washington, DC and Huntsville, AL.

Join Varda, and work to create a bustling in-space ecosystem.

About This Role

Our 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 manufacturi