Quality Control Associate

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

As a Quality Control Associate, you will be responsible for the establishment and execution of analytical testing processes to enable the manufacturing of cell and gene therapies while ensuring compliance with regulatory standards.

• Complete work in compliance with cGMP regulations and expectations

• Perform analytical testing to support process development, cleaning validation, investigations, extended characterization, in-process control, and product release

• Conduct assay transfer and assay validation to meet project timelines

• Perform technical review of data and assess against established acceptance criteria

• Write or review equipment qualification/maintenance life cycle, method implementation documents (protocols and reports), and procedures with input from senior team members

• Participate in project teams and process improvement initiatives

• Identify and communicate potential issues that may affect product quality or regulatory compliance

• Support internal and external audits and regulatory inspections

Who you Are

• Bachelor's degree with 2 years of experience, or Master's degree with 1 year of experience in a relevant subject area

• Experience in the pharmaceutical or biopharmaceutical industry

• Proficient in working with cell or tissue cultures and performing ELISA and potency assays

• Solid understanding of cGMPs or equivalent regulations

• Proven ability to work independently and apply scientific knowledge in analytical or biological test procedures

• Experience in both office and laboratory environments

• Ability to effectively coordinate and present information in various business settings

Preferred:

• Degree in Biology, Biochemistry, Molecular Biology

Physical Requirements:

• Prolonged periods in a laboratory setting

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

• Use of stepladders and pushcarts

• Must pass visual screening

Relocation benefits are not available for this position.

This is an on-site role; no remote or hybrid options are available.

The expected salary range for this position, based on the primary location of Oregon, is $56,900 (min) - $81,300 (mid) - $105,700 (max). 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

#LI-CA1

#ptcareers

#cellandgenetherapycareers#

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.