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20 days old

Process Development Scientist/Sr. Scientist - San Diego, CA

Kelly Services
Westlake Village, CA 91361
**Process Development, Upstream (Bench) - Scientist/Sr. Scientist**


**Job Description:** Position Summary:


This position will be responsible for leading and executing the process development strategy for our preclinical and clinical scale candidates in development. The candidate will be expected to work in collaboration with our internal research group as well as our external manufacturing partners to develop scalable and robust manufacturing processes to support manufacture of AAV based gene therapy products. The candidate will have responsibilities for process development at research scale to support our preclinical candidates and GMP scale to support our clinical candidates.

The successful candidate will be a subject matter expert in process development for AAV based gene therapy products with demonstrated experience in the field. As an early-stage startup this position will require flexibility, creativity and a can-do attitude to enable efficient execution of company objectives. The level of the position will be commensurate with experience.


**Key responsibilities:**

Develop robust, well-characterized, high quality and high yielding upstream production processes for AAV gene therapy products across internal programs.

Lead the effective execution of phase appropriate and risk-based process development strategy to support projects from preclinical to clinical phases.

Design and execute process development studies to develop a thorough understanding of process design space, with a view towards technology transfer to a CDMO and successful regulatory filings.

Identify and implement operational improvements, novel technologies, and industry best practices to improve upstream yield and key quality attributes of viral vectors.

Work with development team to identify and implement product development strategies that enable fast to clinic product development.

Prepare and review experimental protocols, provide technical input, and function in the role of technical liaison between CDMO and development group to ensure that sound scientific decisions are implemented.

Provide operational expertise for the development of companys process development lab.

Contributes to writing of relevant Quality sections of regulatory submissions.

S/he will be highly communicative and function at a high level in a matrixed management environment.

Stay current with emerging process technologies, regulatory guidance on gene therapies, participate in scientific conferences and represent the company to the broader external scientific community.


**Desired Requirements:**

PhD in Chemical Engineering, Biochemical Engineering, Virology or other relevant discipline and a minimum of 2 years of experience in biologics and/or gene therapy process development roles OR a Masters degree in these same disciplines and a minimum of 5 years of relevant experience

Knowledge and familiarity with GLP and GMP requirements as they pertain to upstream process development and clinical manufacturing for gene therapy products.

Good understanding of statistical methods in the application and design of experiments is a plus

Strong knowledge of GMP, GLP, ICH and other regulatory requirements for biological product manufacture.

Excellent written and verbal communications skills, and the ability to present and defend positions and approaches critical to program progression and success.

Understanding of cell-based assays, qPCR, HPLC, ELISA, SDS-PAGE, mass spectrometry and nucleic acid and protein sequencing.

Ability to work in a matrix organization in collaboration with discovery research, nonclinical development, operations, clinical development and with consultants and external service providers


**_For immediate consideration apply today!_**


**_Questions? Please reach out to Dustin at DUSG877@kellyservices.com_**


**_\#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: 2021-04-19 Expires: 2021-05-20

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Process Development Scientist/Sr. Scientist - San Diego, CA

Kelly Services
Westlake Village, CA 91361

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