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Sr Scientist Analytical Development - Irvine

Company: Kelly Services
Location: Tustin
Posted on: September 26, 2019

Job Description:

Sr Scientist Analytical Development - Irvine area, CA

Job Summary:



  • Develop, Troubleshoot and Qualify/validate HPLC / UPLC, CE, Spectroscopy platform assays used for antibodies and biosimilar protein drugs.

  • As a Senior Scientist, this individual will lead a group of 4-5 Scientists/associates to drive the development, optimization and qualification of HPLC platform methods.

  • Lead phase-appropriate Chromatographic method development, regular testing support for process development, product/process characterization, and analytical transfer to QC laboratories for biologics drug substance/drug products.

  • Demonstrated hands-on technical leadership in the laboratory, oversee and delegate experimental/project responsibilities as needed, and write/review protocols/development summary reports.

  • Experience with applying sound scientific principles and innovative approaches of Analytical Chemistry to understand the protein chemistry for therapeutic drugs required.

  • Serve as a HPLC / LC-MS / CE expert on client-facing project teams.

  • Be an effective communicator of ideas, project goals and results to team members across cross-functional roles/departments and clients. Proactively identify issues and develop solutions in a collaborative multidisciplinary environment.

  • Be self-motivated and organized, familiar with the relevant literature, and enjoy scientific investigation and thinking.

  • Lead, motivate, and develop the people in their group.

  • Routinely make decisions affecting direction of project to ensure project timelines are met.

  • Direct research associates or members of project teams (as needed) in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.

  • Participate in client visits presenting on analytical skills and experiences of the team, defining scope of works and timelines as well as estimated stage costs including raw materials.

    Essential Duties and Responsibilities:



    • Responsible for conducting scientific research for the development/testing of HPLC, LC-MS, CE and other analytical methods for biologics.

    • Applies the principles and techniques of Analytical Chemistry to biologics development.

    • Advises Research Associates/Scientists or members of project teams in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.

    • Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.

    • Maintains full working knowledge of principles and theories, applying such knowledge to the direction that supports Company and clients interests.

    • Demonstrates emerging ability in developing methods, techniques and evaluation criteria for obtaining results and interpreting experimental outcomes.

    • Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.

    • May contribute to scientific literature and conferences or regulatory filings.

    • Excellent communication skills (both verbal and technical) and strong interpersonal skills are required.

    • Primary point of contact with a client for HPLC, Mass spectrometry, Capillary Electrophoresis, and other analytical methods (LC-MS, ELISA, and SDS-PAGE). Articulate around the science and problem solving as well as timeline and costs.

    • Develops estimates of timelines, budgets and statements of work to support client requests.

    • Develops capital proposals when lab equipment needs to be purchased, upgraded or replaced.

      Job Requirements:



      • PhD in a relevant scientific discipline (Analytical Chemistry, Bioanalytical Chemistry, and Biochemistry) with 6 years of industry experience is required or MS Degree with 10 years industry experience or BS Degree with 15 years industry experience.

      • Experience in analytical method development for release, stability, in-process testing and product characterization of glycoproteins derived from mammalian cell culture processes.

      • Proficiency with the following techniques is necessary and/or desired: 4-6 years of HPLC / CE development / qualification/transfer experience

      • In addition, 2-4 years of hands on experience with (U) HPLC, capillary electrophoresis, enzyme activity assays, qPCR, spectrophotometry, mass spectrometry is desirable.

      • A background in Chemistry, Analytical Chemistry, Biochemistry, or Biology is preferred.

      • Supervision experience is preferred.

      • Experience with bioanalytical method transfer for drug substance and drug product release and stability testing from other labs and/or into QC is desired.

      • Experience with applying the principles and techniques of Analytical Chemistry is required.

        For immediate consideration, apply today! Questions? Call Toni at 714.454.8252 OR email at toni.marr@kellyscientific.comWhy Kelly--?With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

        You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.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. 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.

Keywords: Kelly Services, Tustin , Sr Scientist Analytical Development - Irvine, Other , Tustin, California

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