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Roche

Head of ADQC - Biological Technologies

Genentech is inviting applications for the Head of Biological Technologies (BT) function within Analytical Development & QC (ADQC) department i n the PTD organization. The BT group is responsible for the development and validation of all in vitro biological methods that are used i n the QC control systems of Genentech clinical and commercial products. The group also supports 1) GMP/GLP lot release/stability testing for clinical products, 2) potency testing for process development, product characterization, comparability, CQA assessment and versions v1.x improvements, and 3) training, transfer and troubleshooting of biological methods to Genentech commercial sites and collaborators/contract manufacturers.

Key Stakeholders and Interfaces include Commercial Quality, gRED, PTDE, PT Regulatory, other technical development functions and Technical Development Teams.

Responsibilities:

  • Lead a group of ~60 Scientists, Managers, and Technical Associates
  • Direct staff and operations to oversee the development, validation, transfer and testing of potency methods for clinical and to-be-marketed products from Phase I to BLA filing.
  • Set strategic direction for BT organization. Select, hire, and train top scientific talent to deliver pipeline molecules.
  • Coach and develop staff by providing an environment that encourages ongoing personal and professional growth. Manage and ensure the setting of realistic personal goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development and growth opportunities
  • Interpret, execute, and recommend improvements to Quality policies, procedures, processes to meet quality and business objectives
  • Provide input to department budget and resource allocation sand monitor and control expenditures against the department budget
  • Be accountable for behaviors described in the Roche Leadership capabilities

Who you are:

  • PhD, B.S. or B.A. degree (preferably in Life Science) and twelve years relevant experience in the biopharmaceutical industry developing Immunological or cell based assays that are representative of the biological mechanism of action for biopharmaceutical products.
  • The candidate will be influential and able to work collaboratively across a global organization.
  • The successful candidate will be a proven people leader, who can develop and retain scientific talent.
  • Oversees a multi-functional organization which supports a continuum of biological activities from early stage development to commercialized products
  • Lead a team responsible for development, validation and transfer of biological methods for clinical and to-be-marketed product from Phase I to BLA filing, in support of GMP/GLP lot release/stability testing and potency testing for process development, comparability, product characterization, CQA assessment and version 1.x improvements
  • Lead scientific innovative effort to identify, evaluate and implement novel technologies for potency testing
  • Develop and defend strategies for Biological Characterization submission and CQA assessments including development/selection of characterization assays, sample selection/testing, data interpretation and authoring BLA section
  • Accountable for potency assay training and technology transfer strategy and execution
  • Support QC sites during potency method related investigations/root cause analysis
  • Provide technical and strategic input into product quality investigations and design testing strategy to support investigation
  • Provide technical and quality control input during the review and approval of applicable documents
  • Collaborate and/or author department or network policies & procedures as needed
  • Interact (Communicate and Negotiate) with cross-functional organizations, external organization (CMO, Roche partners) and Health Authorities (FDA, EMA and others)
  • Influence Biopharmaceutical industries and Health Authorities on trends and policies in the field of potency assays by actively participating in conferences and workshop
  • Contribute to the development of business strategy, ADQC culture and capability, take personal accountability to sponsor ADQC initiatives and projects as requested by leadership as appropriate

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Roche is an equal opportunity employer.

Manufacturing, Manufacturing > Operational Excellence

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