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Quality Control Associate, Environmental Monitoring (HIT)

Hillsboro
Oregon, United States of America


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The Position

Job Description Summary

This position is part of Genentech’s’ Pharma Technical – Hillsboro Individualized Therapies (HIT) team working on the individualized NeoAntigen Specific Therapy (iNeST) platform based in Hillsboro, Oregon. iNeST is a next generation immunotherapy for the treatment of patients with cancer manufactured on a per patient basis. As a member of the HIT QC team, you will be supporting the start-up of a QC laboratory capable of high throughput analysis. You will help define the requirements for QC operations and will establish processes that will enable the QC organization to operate successfully. This role provides the opportunity to closely partner with the Genentech iNeST, development and Global QC teams as you work on start-up activities like establishing the laboratory information management system, qualifying equipment, writing procedures and developing/validating test methods. Responsibilities include performing and reviewing a variety of assays in the Quality Control organization focused on the analysis of an investigational clinical product. Specifically, the ideal candidate will have experience establishing an environmental monitoring program and executing the test methods (bioburden, particle counting, etc.) that used in support of environmental monitoring. Additional responsibilities include LIMS master data management, data system administration and stability program management.

Responsibilities:

  • Interpret data, troubleshoot assay failures and equipment issues while adhering to guidelines on cGMP documentation.
  • Support method cycle development, performance qualifications/validations, method transfers, discrepancy/out-of-specification investigations and collaborate with external groups to identify improvement opportunities in technology and business processes.
  • Independently manage competing priorities with limited instruction.
  • Apply basic theory and technical principles to address moderately complex problems.
  • Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
  • Serve as a technical subject matter expert (SME) in support of department functions.
  • Collaborate with external groups to identify technology and business processes that will support high throughput analytics
  • Define the user requirements for laboratory equipment and support purchasing
  • Support the implementation of the Laboratory Information Management System
  • Support the startup and maintenance of the stability program
  • Receive and provide training
  • Perform any other tasks as requested by Management to support Quality oversight activities

Qualifications: Education, Experience, Knowledge and Skills:

  • B.A. or B.S. degree (preferably in Biochemistry, Chemistry or relevant scientific discipline) and at least 2 years of experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience.
  • Previous experience with individualized therapies is a plus
  • Laboratory start-up experience is a plus
  • Hands-on laboratory experience with microbiological and bioassay techniques
  • Sound knowledge of cGMPs or equivalent regulations
  • Routinely exercises sound judgment, reasoning and problem solving
  • Capable of working under moderate supervision and determining own short-term priorities
  • Work in office and laboratory environment
  • Lift up to 25 lbs may be required
  • Ability to sit, stand and move within work space for extended periods
  • May be required to sit at a computer terminal for extended periods
  • Must be able to travel to other sites for training and method activities as required

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Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.


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