88-50100317 Principal Engineer, Cell Therapy

The Position

Genentech, Inc. seeks a Principal Engineer, Cell Therapy at its Hillsboro, OR location.

Duties: Act as the main point of contact for technical support in manufacturing and engineering, addressing process and equipment issues effectively. Evaluate the consequences of alterations to implemented processes, mitigating risks through thorough process reviews while ensuring compliance. Serve as technical partner to cross-functional teams to provide feedback and recommendations for phase appropriate improvements. Collaborate with process and analytical development to actively process monitor and evaluate upcoming changes to the process. Author, provide technical input and approve of quality records such as deviations, batch records, process description and/or CAPAs. Contributed in process initiatives for internal site transfer from development lab. Lead process transfer avenues for a candidate from a company partner to internal manufacturing facility. Drive a team in establishing and screening capabilities as part of tech transfer to mitigate process risks. Participate with team in performing gap analysis and risk assessment. Collaborate with data analytics team to standardize and digitize data repository, generating data lakes and data visualizations.

Education and experience required: Master’s degree in Biotechnology, Bioengineering, related field, and 3 years of experience in job offered or related position.

Special Requirements:

Position requires at least 3 years of experience with each of the following:

• Aseptic cell culture techniques using various platforms such as CliniMACS Prodigy, cell culture bags or G-Rex bioreactor
• Isolation and culture of immune cells of interests from whole blood by evaluating and optimizing various platforms/processes such as CliniMACS Plus, EasySep Magnets or CliniMACS Prodigy

Position requires at least 1 year of experience with each of the following:

• Applying aseptic cell culture techniques to culture primary cells such as T-Cells or Hematopoetic stem cells
• Execution and data analysis of analytical assays in cell therapy using ddPCR, Flow Cytometry, CFU
• Editing cells of interest, such as T-Cells with lentivirus or hematopoietic stem cells, via electroporation techniques and use of CRISPR/Cas9 reagents to deliver genetic payloads and design product of interest
• Phase appropriate process development, including closing down the open process as phase-appropriate to enable process characterization and validation strategy as the product progresses from preclinical to later stages of the FDA evaluation

The expected salary range for this position based on the primary location for this position of Oregon is $149,928 to $182,712 per year. Actual pay within the range will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits (https://roche.ehr.com/default.ashx?CLASSNAME=splash)

Worksite: 4625 NE Brookwood Pkwy., Bldg. 21, Hillsboro, OR 97124

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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