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Varda Space

In-orbit manufacturing with reentry return services

Principal Engineer - Pharma CMC Manufacturing & Tech Transfer

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeEl Segundo, CA, USA$187k - $239k /yr

About the Job

Requirements

  • At least 10 years of CMC manufacturing and/or technology transfer leadership experience advancing drug product development programs to successful clinical trials.
  • A B.S. or M.S. in life sciences, chemical engineering, or a related field.
  • A firm understanding of current good manufacturing practice (cGMP) and Food and Drug Administration (FDA) regulatory guidelines as they pertain to CMC manufacturing and technology transfer.
  • Demonstrated experience managing external contract development and manufacturing organization (CDMO) or contract manufacturing organization (CMO) relationships, including technical oversight and contract negotiation.

Responsibilities

  • Own technology transfer execution by translating research and development 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, including crystallization, fill-finish, and drug substance partners, through requests for proposals, technical due diligence, and capability assessments.
  • Lead technology transfer of drug product fill-finish processes for the crystalline suspension, partnering with research and development 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 that CDMO-produced material matches Varda-characterized material.
  • As volumes increase, build and lead an internal Manufacturing Sciences & Technology 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, and 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 technology transfer.

Desired Qualifications

  • At least 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 biotechnology or pharmaceutical 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.
  • Experience in an aerospace regulatory environment, such as AS9100.

About the Company

Varda Space

In-orbit manufacturing with reentry return services

Varda Space Industries provides in-space manufacturing by operating production facilities in low Earth orbit and returning finished goods to Earth using reentry capsules. Clients send materials or designs to Varda’s in-orbit production line, where microgravity enables manufacturing processes not possible on Earth. After production, capsules re-enter Earth's atmosphere to deliver goods back to customers, supported by in-orbit equipment and reliable reentry systems. The company aims to make low Earth orbit accessible for multiple industries by building end-to-end space manufacturing infrastructure and industrializing orbit for commercial use.

Company size
201-500
Company stage
Series D
Total funding
$609.5M
Headquarters
El Segundo, CA
Founded
2020

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