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Scientist - Downstream

Company: Yoh, A Day & Zimmermann Company
Location: San Leandro
Posted on: April 10, 2021

Job Description:

Yoh is a seeking a Scientist, Downstream to support an Emeryville Area based company. You will have the opportunity to work within the Manufacturing, Sciences and Technology (MS&T) team to develop robust recombinant protein downstream processes in support of developing and optimizing production processes including process parameter optimization, process characterization, scale-up/tech transfer for large scale product production and support successful implementation of production processes at commercial scale. Title : Scientist, DownstreamLocation: Emeryville, CAType: 1 year contractIndustry: Biotechnology/PharmaceuticalPay: Competitive, depends on experience Responsibilities include but are not limited to:

  • Independently prepares and edits procedures or technical reports of a complex nature, including data interpretation, suitable for regulatory submission.
  • Direct interaction and effective collaboration with project team members, including presenting data at project team meetings; critical review of data; and active involvement in solving technical challenges that arise during development.
  • The individual will be accountable for scientific data review including data integrity verification, statistical analysis and technical report writing.
  • Maintains laboratory facilities and equipment in accordance with company policies (inclusive of safety) and industrial best practices.
  • Lead/assist in the efforts for developing and optimizing downstream processes including process parameter optimization, process characterization and scale-up/tech transfer for large scale product production. Education and Experience Requirements:
    • Educational degrees must be relevant to position (eg, Biology, Biochemistry, Chemistry, or Toxicology): PhD +7 years, MS years or BS years' experience in product development, manufacturing science and technology, process engineering within the pharmaceutical industry required. Title to be adjusted based on applicant experience/education. Key Skills, Abilities, and Competencies :
      • Proficient with the use of MS Office software (MS Excel, MS Word, MS Powerpoint) and application software including Unicorn, JMP, Minitab, Design Expert, etc. Complexity and Problem Solving :
        • Has considerable knowledge and technical expertise in protein purification of recombinant proteins and monoclonal antibodies.
        • Hands-on experience in modern protein purification techniques (chromatography, affinity, ion-exchange, hydrophobic, mixed mode, experience working with AKTA, Unicorn, clarification/filtration, and ultrafiltration/diafiltration) is required.
        • Execute protocols ranging from resin screening, chromatography, filter sizing and TFF optimization.
        • Working knowledge of AKTA Avant, Pilot, and/or Ready systems and associated software, AKTA Unicorn and Assist software.
        • Working knowledge and ability to program Unicorn and Assist Plate Reader software or an equivalent.
        • Knowledge of process scale-up and scale-down methodologies, including process characterization and design of experiments
        • Experience in process technology transfer within and between organizations, manufacturing support and troubleshooting
        • Design and write up studies to characterize Downstream process parameters with high risks identified in the Lifecycle Stage 1 risk assessments to define their criticality and to define Proven Acceptable Ranges (PAR) for Critical Process Parameters (CPPs)
        • Understanding of basic statistical data analysis and a willingness to explore advanced statistical modelling tools.
        • Working knowledge and experience working in cGMP environments (understanding of equipment, technology, and quality systems requirements)
        • Skilled in application of standardized root cause analysis, investigation tools and methodologies.
        • Strong organizational skills in prioritizing personal tasks to meet deadlines and collaborate proactively with achieving goals.
        • Demonstrated ability to develop new techniques, solve complex problems, author technical protocols and reports; and evaluate and implement new instrumentation or process techniques. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit to contact us if you are an individual with a disability and require accommodation in the application process.PandoLogic. Keywords: Senior Scientist, Location: San Leandro, CA - 94577

Keywords: Yoh, A Day & Zimmermann Company, San Leandro , Scientist - Downstream, Other , San Leandro, California

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