Senior Scientist (Analytical Method Development)- San Diego, CA
Company : Kelly
Country: United States
Location : San Diego, California
Post: Sat, 11 Sep 2021 05:19:14 GMT
Expires: Mon, 11 Oct 2021 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
The Senior Scientist, AMD, is responsible for development, prequalification and qualification/validation of a wide range of large molecule focused analytical methods within the Analytical Method Development (AMD) group. Specifically, the individual will develop and optimize analytical methods to support process development, in-process monitoring, drug substance and drug product testing, specifications, method qualification/validation protocols and reports. This position is a hands-on bench role that requires an extensive skillset and knowledge base to enable the successful applicant to be self-directed. Leads development programs as a matrix team lead. Proposes and implements new platform technologies increasing analytical capabilities, plays a key role in improving processes, procedures, mentors and trains junior personnel. The Senior Scientist will collaborate with QC, QA, Project Management, Process Development, and collaborate and communicate withclients on clinical stage and commercial therapeutics to improve the lives of patients.
* Develops and conducts independently and/or collaboratively all aspects of analytical methods to support process development, product pre-formulation studies, in-process monitoring, drug substance, and drug product testing.
* Develop HPLC separations, HPLC-MS, Capillary Electrophoresis, ELISA Immunoassays, Western blots, Protein Titer (HPLC, ELISA and SPR) and other analytical protein characterization methods.
* Perform method pre-qualification and qualification/validation, authors analytical test methods/qualification protocols, development and prequalification reports and leads method transfer to the Quality Control laboratory.
* Maintains and demonstrates knowledge of the drug development process from development through commercial manufacturing including regulatory requirements and guidelines.
* Acts as an intellectual resource for his/her area of expertise by supporting assay troubleshooting, investigations and improving analytical methods as needed.
* Proposes and implements new platform technologies increasing analytical capabilities, plays a key role in improving processes, procedures, mentors and trains junior personnel.
* Leads project matrix teams and acts as an effective team player achieving corporate objectives through active participation in project teams and initiation and maintenance of effective interactions with clients and company sites.
* Participates in strategic thinking and planning.
* Reviews and interprets complex data and performs statistical analyses by using appropriate software (e.g., JMP etc).
* Communicates scientific data and concepts effectively through presentations, protocols, test methods and reports.
* B.S. degree 10 years, M.S. with 8 years or Ph.D. 5 years industrial experience in a relevant discipline, (e.g., chemistry, biochemistry, biological sciences, bioengineering, etc.).
* Extensive experience in method development/optimization, qualification and validation of analytical methods in areas related to some or all of the following: HPLC separations, HPLC-MS, Isoelectric Focusing, Capillary Electrophoresis, ELISA Immunoassays, Western blots, Protein Titer (HPLC, ELISA and SPR) and other analytical protein characterization methods.
* Knowledge and experience in analytical method qualification and validation
* Control strategy of large molecules for drug substance and drug product, phase appropriate regulatory filing strategies in U.S. and outside U.S.
* Knowledge and experience in cGMP, ICH guidelines, USP and EP compendial methods.
* Ability to work well under pressure on multiple tasks, organize and communicate complex project information.
* Good oral and written communication skills.
* Ability to work both independently and collaboratively.
* Experience with software such as Microsoft office suite and Sharepoint. Familiarity with scientific software such as SoftmaxPro and Octet, and performing statistical analysis using DoE, JMP.
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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. [
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