Principal Engineer, Pharma CMC Manufacturing & Tech Transfer (Aerospace)

Location: On-site in El Segundo, California, United States. Candidates must be U.S. persons authorized to access export-controlled technology.

Salary: $187,000–$239,000 per year, plus eligibility for stock options and/or long-term cash awards.

Company

hirify.global develops in-space pharmaceutical processing, reentry capsules, heat shields, and satellite buses, with products and infrastructure built, integrated, and tested in-house.

What you will do

• Own technology transfer execution from R&D-developed processes to robust, CDMO-ready manufacturing packages.
• Lead pilot plant production, engineering runs, CDMO site acceptance, and comparability protocols for nonclinical and clinical material.
• Select, qualify, and manage crystallization, fill-finish, and drug substance CDMO partners, including RFPs, technical due diligence, and capability assessments.
• Negotiate and manage Manufacturing Services Agreements and establish CDMO oversight, handoff, and chain-of-custody models.
• Build and lead an internal Manufacturing Sciences & Technology function as manufacturing volumes increase.
• Oversee GMP campaigns through batch release and manage manufacturing timelines, budgets, quality coordination, and regulatory CMC deliverables.

Requirements

• 10+ years of CMC manufacturing and/or technology transfer leadership experience advancing drug product 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 for CMC manufacturing and technology transfer.
• Demonstrated experience managing external CDMO/CMO relationships, including technical oversight and contract negotiation.

Nice to have

• 13+ years of CMC manufacturing leadership experience with direct responsibility for process transfer and CDMO network management.
• Experience with small-molecule and/or biologics crystallization processes or high-concentration suspension drug products.
• Experience establishing a CDMO network from partner selection through GMP manufacturing for an early-stage or growth-stage biotech/pharma company.
• Hands-on experience with aseptic fill-finish operations and engineering/media fill runs.
• Advanced understanding of cGMP and FDA regulations and guidance for CMC manufacturing and comparability.
• Leadership, management, and communication skills in a cross-functional, multi-site environment.
• Experience in an aerospace regulatory environment such as AS9100.

Culture & Benefits

• On-site work at the El Segundo production facility and offices.
• Collaboration with Pharma R&D, Quality & Regulatory, Legal, external CDMOs, and executive leadership.
• Stock options and/or long-term cash awards may be available.
• Inclusive, equal-opportunity workplace with evaluation based on merit, qualifications, and performance.