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Scientist / Sr. Scientist Analytical Process Development - Irvine

Company: Kelly Services
Location: Tustin
Posted on: July 2, 2019

Job Description:

Scientist / Sr. Scientist Analytical Process Development, Irvine-area, CA

Position Summary:

  • Lead phase-appropriate analytical method development and transfer to QC laboratories for biologics drug substance/drug product release and stability testing as well as development of in-process and product characterization methods.

  • Lead biologics method development and testing support for process development.

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

  • Serve as an analytical representative 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 of analytical methods for biologics.

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

    • Advises Research Associates 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 project contact with a client for the analytical method development scope. 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.

    • This position may supervise 2 - 4 Research Associates.

      Job Requirements:

      • PhD in a relevant scientific discipline with 2 years of industry experience is required (5 years for Senior), or

      • Master's degree (MS) with 5 years of industry experience (10 years for Senior), or

      • Bachelor's degree (BS) with 8 years of industry experience (15 years for Senior).

      • Background in Chemistry, Analytical Chemistry, Biochemistry, or Biology is preferred.

      • 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: (U)HPLC, capillary electrophoresis, immunoassays, enzyme activity assays, qPCR, spectrophotometry, mass spectrometry.

      • Supervision experience is desired.

      • 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.

      • Knowledge of GMPs is desired.

        For immediate consideration, apply today! Questions? Call Toni at 714.454.8252 OR email at toni.marr@kellyscientific.com

        Why Kelly--?

        With Kelly, youll have access to some of the worlds highest-regarded scientific organizations

        providing 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 95 of the Fortune 100 companies, and found opportunities for more than 9,000

        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.


        Kelly Services--

        As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect

        with us on Facebook, LinkedIn and Twitter.Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,

        Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is

        committed to employing a diverse workforce. Equal Employment Opportunity

        is The Law.

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

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