Executive Director, Process Development & Manufacturing

Janux Therapeutics • San Diego, CA

18d • $280,000 - $296,000 • Onsite

About The Position

As a senior leader within the CMC organization, the Executive Director, Process Development & Manufacturing provides strategic and technical leadership for the development, scale-up, technology transfer, and clinical manufacturing of Janux therapeutic candidates. The role advances the pipeline from research and early clinical development through clinical manufacturing and late-stage development, working closely with Analytical & Formulation Development, Quality, Regulatory Affairs, Supply Chain, Clinical, Research, and other functions to define integrated development and manufacturing strategies.

The Executive Director leads the internal team and provides technical oversight of CDMOs supporting process development across cell line development, cell culture, downstream purification, and drug substance and drug product manufacturing. The role is accountable for establishing robust, scalable, and phase-appropriate manufacturing processes and provides leadership for late-stage process development, including process characterization, control strategy development, validation readiness, comparability, lifecycle management, and CMC content for global regulatory submissions.

Requirements

• Ph.D. in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnology, Biochemistry, Cell and Molecular Biology, or a related discipline, with 12+ years of relevant biotechnology or biopharmaceutical industry experience; alternatively, an M.S. with significant additional relevant industry experience.
• Extensive biologics process development and manufacturing experience, with strong knowledge of mammalian cell culture and downstream purification processes.
• Demonstrated experience advancing biologic products from early development through clinical manufacturing and late-stage development.
• Strong understanding of mammalian cell line development and recombinant protein expression.
• Strong technical understanding of upstream processing, including media and feed strategies, bioreactor process development, scale-up, and process parameter optimization.
• Strong technical understanding of downstream processing, including harvest/clarification, affinity capture, chromatography, filtration, viral safety, and TFF/UFDF operations.
• Significant experience with late-stage process development, process characterization, control strategy development, scale-up, technology transfer, validation readiness, and commercial manufacturing preparation.
• Proven experience providing technical oversight of external CDMOs, including process development, technology transfer, GMP manufacturing, and manufacturing investigations and troubleshooting.
• Experience contributing to CMC sections of regulatory filings and supporting health authority interactions.
• Proven leadership experience, including building, managing, and mentoring high-performing technical teams.
• Demonstrated ability to operate effectively in a fast-paced biotechnology environment and manage multiple programs and priorities.
• Excellent cross-functional collaboration, influencing, communication, and executive presentation skills.
• United States work authorization is required.

Nice To Haves

• Experience with bispecific, multispecific, or T-cell engager biologics.
• BLA/MAA filing and PAI experience.

Responsibilities

• Provide strategic and technical leadership for cell line, cell culture, and downstream process development for drug substance manufacturing, supporting progression from research and preclinical development through early- and late-stage clinical development and commercialization.
• Lead development and optimization of robust, scalable, and phase-appropriate manufacturing processes, considering yield, product quality, process consistency, manufacturability, and cost.
• Provide technical direction for mammalian cell line development, cell culture, harvest and clarification, chromatography, filtration, UF/DF, and other drug substance unit operations.
• Lead late-stage process development and characterization strategies to establish process understanding and support commercial manufacturing readiness.
• Provide technical leadership for process characterization, identification of critical process parameters, definition of operating ranges, and development of robust manufacturing control strategies.
• Provide technical and strategic leadership for manufacturing changes, scale changes, site transfers, process improvements, and comparability assessments as programs advance.
• Oversee drug product technology transfer, aseptic fill/finish, and drug product campaigns at CDMOs, including container closure and CCI.
• Provide technical leadership and oversight for technology transfer, scale-up, cGMP clinical manufacturing, and late-stage manufacturing activities at external CDMOs.
• Oversee manufacturing campaigns and lead or support resolution of complex technical issues, deviations, process performance challenges, and manufacturing risks.
• Work cross-functionally with Quality and Supply Chain to support reliable manufacturing execution and clinical supply.
• Partner with Quality and Regulatory Affairs to ensure process development and manufacturing strategies support global regulatory expectations throughout clinical development.
• Evaluate external manufacturing capabilities and contribute to CDMO selection, manufacturing network strategy, and longer-term commercial manufacturing planning.
• Ensure knowledge generated during internal and external process development is transferred effectively and incorporated into manufacturing processes and control strategies.
• Contribute to BLA/MAA filings and PAI activities; experience is highly desired.

Benefits

• Annual bonus program and target bonus.
• Incentive stock options, restricted stock units, and an employee stock purchase plan (ESPP).
• 401(k) plan with flat non-elective employer contribution.
• Comprehensive medical insurance with 90–100% employer-paid premiums.
• Dental and vision insurance.
• HSA, FSA, and supplemental insurance plans, including life, disability, accident, critical illness, and hospital indemnity coverage.
• Unlimited PTO.
• Generous holiday schedule, including summer and winter company shutdowns.
• Relocation assistance may be available.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree