San Diego, California

Kelly is actively recruiting for a Direct Hire – Associate Director/Director Process Science in San Diego, CA.

Associate Director/Director Process Sciences

Position Summary

  • This position within the Process Sciences group is for an Associate Director/Director to lead technology transfer, development and manufacturing activities at contract manufacturing organizations, and participate in strategic CMC planning and messaging to program teams and Executive Leadership. The candidate will collaborate with Quality, Regulatory, Clinical, and Research functional areas to help advance clinical and pre-clinical programs. The role also requires working closely with Analytical / Formulation, Upstream and Downstream team members and provide technical guidance for internal lab-scale research protein production and development operations.

The specific responsibilities include:

  • Manage technical development and manufacturing operations at Contract Development and Manufacturing Organization (CDMOs)
  • Ensure timely cGMP manufacture with adherence to Quality Management Systems
  • Develop/direct robust, scalable, well characterized and cost-effective processes for the biologics pipeline
  • Manage process scale-up, facility fit analysis, optimization studies and process transfer #160DL
  • Manage late-stage clinical CMC development including process characterization/validation studies (e.g. scale-down models and design of experiment approach to identify critical process parameters) and process validation at the CDMO, including review of development, process characterization and validation protocols and reports
  • Serve as subject matter expert and provide technical expertise for process-related trouble?shooting, and Quality support leveraging industry-standard root cause analysis methodologies.
  • Communicate clearly with program stakeholders, technical staff, consultants and CDMO partners
  • Write and review high quality source documentation to support global regulatory filings


  • 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
  • Strong background and subject matter expertise in upstream or downstream unit operations including cell line development, bioreactor operations, clarification, liquid chromatography, ultrafiltration/diafiltration, viral clearance and the impact of process conditions on product quality and scale-up manufacturing of recombinant proteins and antibodies
  • Demonstrated process development, technology transfer and scale-up of bioprocess manufacturing experience
  • Demonstrated process characterization and validation experience
  • Working familiarity with analytical method requirements stage-appropriate to program development status
  • Extremely detail-oriented, thorough, and diligent in experimental design, data analysis and review
  • Experience with both mammalian and microbial systems is highly desirable
  • Knowledge of cGMP and regulatory requirements related to biologics manufacturing and controls, including authoring relevant CMC sections of IND/BLA filings
  • High level of motivation, initiative and creativity
  • Excellent organizational skills and ability to execute on multiple projects in parallel
  • Excellent written, verbal and presentation communication skills
  • 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

If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.


You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Why Kelly®?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.


San Diego, California

Why Kelly - Since 2011 we have placed over 16,000 Veterans

Need More?

Kelly applies targeted recruiting initiatives to the Veterans population (in all stages of transition) by aligning customer defined requirements with military skills and experience.  The transition from military to civilian life can be stressful and complex for veterans, and our staff is trained to assist in this transition.  Unlike our competition, Kelly places these resources without geographic or industry constraints, offering our customers and our employees greater flexibility.  Kelly has a wide variety of local opportunities, for Veterans and their spouses, within our workforce solutions as well as national recruiting programs on behalf of our customers.  Kelly’s leading placement opportunities for Veterans are within Information Technology, Engineering, Science, Light Industrial and Call Center.

Our specially trained Veteran recruiters are armed with a number of tools to help Veterans obtain roles that match their potential including skill translation tools, leading Veteran- centric job boards and Veteran/spouse social media networks, among others.

Through Kelly’s vast branch network, we are closely located to the majority of major military installations across the United States.  Kelly recruiters participate in onsite and virtual military career fairs as well as advertise through local and national Veteran job boards.  In recent years, over 150 Kelly branches have worked directly with their local military installations to recruit spouses and transitioning personnel.  These teams not only engages with transitioning talent from local bases, but also have a strong focus on Veterans in areas where the military has identified high Veteran unemployment. This approach ensures that military talent is engaged and shared across the centralized military recruiting team and documented in a centralized database, so that other Kelly locations can benefit from hiring or relocating this valuable pool of talent.

Our focus on military recruiting is a win on multiple levels. Kelly gains top talent with the skills needed to excel; our clients receive the benefit of that talent to help them compete in an ever challenging business landscape; and Veterans receive gainful employment in line with their skills and abilities to ease the transition to the next phase of their lives.

A People Company, Staffing the World

Kelly founded the temporary staffing industry in 1946, and has maintained a leadership position through the years based on a valuable premise: we invest in people. Today that focus benefits our customers wherever they operate around the globe - in a growing number of specialized fields. And we’ll continue to meet the evolving challenges of workforce flexibility with staffing solutions tailored to your precise business needs, both locally and worldwide.

Similar jobs