QC Associate; Molecular Biology

The Position

This position is part of a consolidated Analytical Development and Quality Control (ADQC) team within Genentech’s cutting edge Pharma Technical Cell and Gene Therapy (PTC) organization. PTC is dedicated to advancing cell and gene therapies aimed at treating or curing various diseases. In this position, you'll support development and conduct quality control (QC) activities to support the clinical progress of cell and gene therapies.

This role is a key part of our Analytical Sciences team, dedicated to ensuring the highest quality standards for raw materials, in-process samples, and finished products. Our team conducts both routine and complex chemical and biochemical analyses, supports stability programs, and plays a critical role in maintaining and calibrating laboratory and analytical equipment. By collaborating with cross-functional teams and contributing to method development, equipment qualification, and reagent management, this team ensures the integrity of our products, directly supporting our mission of delivering safe and effective solutions to our patients.

The Opportunity:

As a QC Associate (Molecular Biology), you will play a vital role in implementing and performing analytical methods that support Cell and Gene Therapy manufacturing. You will ensure product quality and production consistency while collaborating with cross-functional teams to meet clinical and commercial milestones.

Key responsibilities include:

• Conducting analytical testing, qualifying and validating methods, and implementing new molecular biology procedures to support GMP production.
• Drafting and reviewing documentation for method implementation, equipment qualification, and procedural updates.
• Collaborating with Technical Development Teams (TDTs), Pharma Technical Cell Therapies (PTCC), Pharma Technical Development (PTD), and global teams to enable clinical proof of concept and readiness for commercial manufacturing.
• Calibrating, maintaining, and troubleshooting laboratory and analytical equipment to ensure operational accuracy.
• Developing and improving molecular and potency testing assays for routine and non-routine analyses.
• Technically reviewing data for compliance with acceptance criteria, addressing technical issues, deviations, and discrepancies.
• Supporting regulatory inspections, internal audits, and compliance initiatives to maintain quality standards.

Who You Are:

• You possess a Bachelor’s degree in Biology, Chemistry, Biochemistry, Molecular Biology, or a relevant scientific discipline with at least 2 years of laboratory experience in the pharma or biopharmaceutical industry.
• You have demonstrated experience in executing, qualifying, and validating molecular biology-based methods such as PCR, qPCR, ddPCR, Sanger Sequencing, and Next-Generation Sequencing (NGS).
• You possess the ability to apply scientific theories and techniques to analytical or biological testing in a Quality Control or GMP-regulated environment.
• You have a proven ability to interpret and implement Quality standards while ensuring regulatory compliance.
• You possess proficiency in molecular biology techniques, analytical test method development, equipment qualification, and quality system documentation.
• You have strong stakeholder management skills with experience collaborating effectively across matrixed, cross-functional global teams.
• You possess excellent communication, organizational, and problem-solving skills, with the ability to prioritize tasks and meet deadlines in a dynamic environment.
• You are able to work in both office and laboratory settings, with extended periods working at benches and frequent lifting (up to 25 lbs), bending, reaching, and twisting

Preferred:

• Cell therapy QC experience
• Understanding of cGMPs or similar regulations
• Experience in immunoassays such as ELISA

The expected salary range for this position based on the primary location of Oregon is $64,800 (min) - $92,500 (mid) - $120,300 (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…