The Position

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. 

Pay Rate - $33-$37/hour (depends on experience)
Shift: Day Shift: 8:00 am to 4:30 pm

Contract duration: 12 months (possible extensions up to 36 months)

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 releasePerform and support analytical activities, including assay transfer and validation, to meet project timelinesConduct technical reviews of data, comparing with established acceptance criteriaWrite or review qualification/maintenance lifecycle documents, method implementation documents, and procedures with senior team member inputParticipate in project teams, process improvement initiatives, internal and external audits, and regulatory inspectionsIdentify, 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 experienceYou have experience performing flow cytometry assays and analysisYou 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 proceduresYou have experience working in an office and laboratory environment 

Preferred:

Degree in Biology, Biochemistry, Molecular BiologyExperience 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

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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