Associate Director, Downstream Process Development and Manufacturing

San Diego, CA /
Technical Operations /
/ Hybrid
Inhibrx is a clinical-stage biopharmaceutical company focused on the treatment of oncology, infectious disease, and inflammatory conditions. Inhibrx's proprietary platforms, including multi-specific and multivalent molecules, and technologies enable fit-for-function biotherapeutics that optimally interface with the biology of each target antigen, focus immune activation, and mediate enhanced signaling. We have multiple clinical trials underway with other development candidates progressing toward the clinic. In addition, we also have several discovery programs that are advancing toward the development stage.

With the transition of clinical candidates form early to late stage development, Inhibrx has an opportunity for an experienced Associate Director to contribute and lead the downstream late stage/commercial development and manufacturing of our therapeutic candidates. This position will report to the Head of Purification Process Development and Manufacturing.

The specific responsibilities include:

    • Development of robust, scalable, well characterized and cost-effective downstream processes for the biologics pipeline.
    • Support Research stage molecules including protein production and molecule/process assessment activities.
    • Process scale-up, facility fit analysis, optimization studies and successful process transfer.
    • Ensure timely GMP manufacture with adherence to Quality Management Systems
    • Batch record technical reviews.
    • Technical management of development and manufacturing operations at Contract Development and Manufacturing Organization (CDMOs).
    • Lead process characterization/validation studies (including FMEA, scale-down model establishment and design of experiment approach to identify critical process parameters) and process validation, including review of development, manufacturing, process characterization and validation protocols and reports.
    • Serve as subject matter expert and provide technical expertise to process related trouble-shooting, and Quality support
    • Communicate clearly with program stakeholders, technical staff and CDMO partners.
    • Ensure high quality source documentation to support global regulatory filings, including writing/reviewing).

Knowledge, Experience and Skills

    • A Master’s or Ph.D. degree (Ph.D. preferred) in Biochemistry, Chemical/Biochemical Engineering, Chemistry, Biological Sciences or other relevant science or engineering field, with at least 10+ years of relevant industrial experience.
    • Supervisory experience is desirable.
    • Strong background and subject matter expertise in purification unit operations including column chromatography, filtration (UF, DF, TFF), harvest and viral clearance validation in the manufacture of recombinant proteins and antibodies.
    • Late stage downstream development and contract manufacturing technical management experience.
    • Collaborate effectively with internal and external functional domains, including early stage CMC groups to increase product knowledge and identify improvement opportunities, Quality, external partners and CDMOs.
    • Critical and creative thinking skills for problem solving, working independently and strong organizational and planning skills.
    • Knowledge of biologics regulatory guidelines including FDA/ICH on risk management, technology transfer and process validation.
    • Demonstrated BLA filing, regulatory interactions, and commercial launch experience.
    • Comfortable working in a high impact, fast-paced and lean biotech start-up environment. Ability to learn and act on dynamic information at a rapid pace.


    • 100% Employer-paid medical, dental, vision, and long-term disability insurance (eligible upon start)
    • 5% 401(k) match (eligible upon start)
    • Annual tuition reimbursement (eligible after 1 year of employment)
    • Unlimited paid time off
The anticipated salary range for candidates is $160,000 to $200,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.

Inhibrx is an equal opportunity employer. We are committed to fair hiring practices and to maintaining a workforce comprised of individuals that are as unique as our science. We do not discriminate against any employee or applicant based on race, sex, sexual orientation, gender identity or expression, age, religion, national origin, citizenship status, disability, veteran status or any protected category prohibited by local, state or federal laws.