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Technical Development Research Associate or Senior Technical Development Research Associate

Company: Hoffmann-La Roche Ltd
Location: South San Francisco
Posted on: June 8, 2021

Job Description:

Genentech's Cell Banking organization is seeking a highly motivated cell culture research associate to support various aspects of R&D and cGMP cell bank production. The Cell Banking group is responsible for generating cell banks in support of both clinical and commercial drug substance manufacturing. In addition, the Cell Banking group is responsible for monitoring, troubleshooting, and improving the Cell Banking processes in both the R&D and GMP environment, and providing scientific and technical judgment as part of a team responsible for delivering high quality biopharmaceutical products to patients. Integrity, accountability, and strong dedication to the patients we serve are critical to this role. The level of this role will be dependent on experience.

Responsibilities

  • Analyze data and execute experiments aimed at improving process robustness/productivity or meeting the changing needs of the Cell Banking organization.

  • Implement engineering projects of various magnitude in order to increase levels of safety and/or compliance, improve process and equipment robustness, or increase capacity/productivity/efficiency.

  • Adhere to all applicable compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents

  • Monitor and analyze manufacturing data as necessary to provide support for process discrepancies, equipment troubleshooting, investigations, or development activities.

  • Support of regulatory inspections and filings

  • Create, own, and/or review discrepant events, investigations, change records, and risk management documents for Cell Banking, as needed.

  • Support GMP operations

Qualifications

  • Bachelor's/Master's/PhD degree in Engineering, Science, or related discipline

  • 3+ years of relevant experience in industry or academia (including advanced studies); candidates with more extensive experience may be considered for a senior level.

  • Experience working in a cGMP environment is preferred

  • Experience with cell culture process science/development

  • Knowledge of safety principles, quality systems, and cGMP

  • Knowledge of biopharmaceutical manufacturing processes and equipment

  • Relevant work experience in a lab, pilot plant, manufacturing, or manufacturing support setting

  • Highly motivated and proactive with a track record of taking initiative to achieve business results

  • Demonstrated strong problem solving capabilities

  • Able to work independently and as part of a team

  • Strong oral and written communication skills

  • Excellent organization skills

Additional qualifications for senior level:

  • Extensive experience with practical and theoretical application of Engineering/Scientific/GMP theories, principles and techniques. Able to apply expert knowledge, ask deeper questions, and proactively seek answers to complex problems.

  • Expert understanding of biopharmaceuticals, Cell Culture manufacturing processes, validation concepts, equipment and facilities. Develops solutions to a variety of complex problems and initiatives.

  • Experience defending site practices during internal audits and regulatory inspections is preferred

  • Relevant experience mentoring and developing those with similar or less expertise

  • Proven ability to lead cross-functional teams or projects

  • Represents department/organization on projects or teams of moderate to complex scope

  • Leads cross functional teams or projects of moderate to complex scope (ex: core team lead, teams defining network best practices, teams improving complex business processes)

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Keywords: Hoffmann-La Roche Ltd, South San Francisco , Technical Development Research Associate or Senior Technical Development Research Associate, Other , South San Francisco, California

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