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9 days old

Associate Director/Director Process Sciences - San Diego, CA

Kelly Services
San Diego, CA 92108
**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


**Requirements:**


+ A Masters 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.**


**_\#TJP2021_SPEC_**


**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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-10-11 Expires: 2021-11-11

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Associate Director/Director Process Sciences - San Diego, CA

Kelly Services
San Diego, CA 92108

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