Quality Control Associate (Flow Cytometry)

This position is part of Genentech’s Pharma Technical – Hillsboro Innovative Therapies (HIT) team working on various individualized and non-individualized cell and gene therapies based in Hillsboro, Oregon.

As a member of the HIT Analytical Development and Testing (ADT) team, you will be implementing various analytical methods to enable the manufacturing of DNA/RNA and cell therapeutics. You’ll be part of the consolidated analytical development team responsible for supporting the development of new modalities in the newly created Pharma Technical Cell and Gene Therapy (PTC) organization. PTC focuses on the development of cell and gene therapies for the treatment or cure of various diseases. 

The Opportunity

The Quality Control Associate will be responsible for the establishment of processes for, and execution of, analytical testing to enable the manufacturing of cell and gene therapies. In this role, you will perform Quality Control operations according to established processes to ensure production consistency and product quality as well as support analytical development for the clinical development of cell and gene therapies. Additionally, you will:

• Ensure compliance with cGMP regulations 

• Conduct analytical testing for process development, cleaning validation, investigations, extended characterization, in-process control, and product release

• Perform and support analytical activities, including assay transfer and validation, to meet project timelines

• Conduct technical reviews of data, comparing with established acceptance criteria

• Write or review qualification/maintenance lifecycle documents, method implementation documents, and procedures with senior team member input

• Participate in project teams, process improvement initiatives, internal and external audits, and regulatory inspections

• Identify, communicate, and address potential quality or regulatory issues impacting product quality or compliance

Who you Are

• You have a bachelor's degree and two years of experience OR a graduate degree plus one year of experience

• You have experience performing flow cytometry assays and analysis

• You have demonstrated knowledge of cGMPs or equivalent regulations 

• You have demonstrated knowledge and application of scientific theories, principles, and techniques used in analytical or biological test procedures

• You have experience working in an office and laboratory environment 

Preferred:

• Degree in Biology, Biochemistry, Molecular Biology

• Experience in pharmaceutical or biopharmaceutical industry

Work Environment/Physical Demands/ Safety Considerations:

• Prolonged periods of standing/sitting at lab bench top 

• Frequent lifting (up to 25 lbs), bending, reaching, twisting 

• Use of stepladders and pushcarts 

• Must be able to pass a visual screening assessment

Relocation benefits are not available for this position.

The expected salary range for this position, based on the primary location of Oregon, is $56,900-$105,700.  Actual pay 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

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Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.