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16 days old

Sr. Scientist (Analytical Development) - San Diego, CA

Kelly Services
Richmond, CA 94802
**Sr Scientist, Analytical Development**


Position Description:


This position of Sr. Scientist, Analytical Development team, will lead the development, optimization, and transfer of analytical methods to support our process development and quality control. The successful candidate will be experienced with development and validation of physicochemical assays and will drive the phase-appropriate method development, optimization, qualification and tech transfer. The candidate will be expected to design and perform experiments and, organize, document, analyze and interpret results with a high degree of independence and leveraging sound scientific principles.


Key responsibilities:


- Establish and oversee a high performing team capable of supporting analytical development activities with an emphasis on physicochemical, biological, and compendial methods.

- Evaluate and implement new technologies within the Analytical Development group, with a particular emphasis on separation techniques (HPLC/UPLC and CE), and binding based assays.

- Write/review SOPs, test method protocols, assay development and qualification plans/reports.

- Write/review analytical sections of IND/IMPD filings.

- Provide mentorship and training of junior level scientists in the laboratory.

- Coordinate activities of outside resources such as consultants and vendors.

- Represent analytical development group in project meeting.


Qualifications:


- Ph.D. in Biochemistry, Analytical Chemistry or a related discipline with a minimum of 4 years of relevant industry work experience or a Masters or Bachelors degree with a minimum of 6 years of relevant industry experience.

- Proven expertise/experience in developing and qualifying/validating analytical methods to support product development and QC batch release, preferably for biologic products.

- Strong background in physicochemical methods (e.g. UPLC/HPLC, CE) and bioassays (ELISA, qPCR), excellent instrument and method troubleshooting skills, as well as knowledge of various data analysis approaches.

- Understanding of regulatory requirements for early-stage development of biologics including compendial requirements as well as requirements associated with the assessment of critical quality attributes, control strategies, stability, and comparability as outlined in ICH Guidelines and FDA guidance documents.

- General understanding of statistical principles supporting method performance and robustness assessments as well as Design of Experiment approaches used for method development / optimization.

- Excellent communication skills.

- Experience managing people in project-based or functional teams.

- Working experience in biologic formulation development is a plus.


**_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: 2021-03-29 Expires: 2021-05-06

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Sr. Scientist (Analytical Development) - San Diego, CA

Kelly Services
Richmond, CA 94802

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