Executive Director, Process Development & Manufacturing

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

The successful candidate will lead the internal team and provide technical oversight of Contract Development and Manufacturing Organizations (CDMOs) for process development activities across cell line development, cell culture and downstream purification as well as drug substance and drug product manufacturing, with accountability for establishing robust, scalable, and phase-appropriate manufacturing processes. The role will also provide leadership for late-stage process development, including process characterization, control strategy development, process validation readiness, comparability, lifecycle management, and preparation of CMC content for global regulatory submissions.

ESSENTIAL FUNCTIONS AND 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 with appropriate consideration of yield, product quality, process consistency, manufacturability, and cost.

Provide technical direction for mammalian cell line development, cell culture, harvest/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 DP tech transfer, aseptic fill/finish, and DP 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.

Provide oversight of manufacturing campaigns and lead/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 appropriately support global regulatory expectations throughout clinical development.

BLA/MAA filing and PAI experience highly desired.

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 effectively transferred and incorporated into manufacturing processes and control strategies.

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES

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, or an M.S. with significant additional relevant industry experience.

Extensive experience in biologics process development and manufacturing e.g. bispecific or multi-specific or T cell engager 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/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.

Job Type: Full-time   Benefits: ·         Annual bonus program ·         Incentive stock option plan ·         401k 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 (life, disability, accident, critical illness, hospital indemnity) ·         Unlimited PTO ·         Generous holiday schedule; includes summer and winter company shutdown ·         Relocation assistance   Schedule: ·         Monday to Friday   Work authorization: ·         United States (Required)   Additional Compensation: ·         Annual targeted bonus %   Work Location: ·         On site (San Diego, CA)   EQUAL OPPORTUNITY EMPLOYER: Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity. Notice to Recruiters and Third-Party Agencies The Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.