QC Associate (Molecular Biology)

Roche•Hillsboro, OR

1d•Onsite

About 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. 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.

Requirements

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.
Demonstrated experience in executing, qualifying, and validating molecular biology-based methods such as PCR, qPCR, ddPCR, Sanger Sequencing, and Next-Generation Sequencing (NGS).
Ability to apply scientific theories and techniques to analytical or biological testing in a Quality Control or GMP-regulated environment.
Proven ability to interpret and implement Quality standards while ensuring regulatory compliance.
Proficiency in molecular biology techniques, analytical test method development, equipment qualification, and quality system documentation.
Strong stakeholder management skills with experience collaborating effectively across matrixed, cross-functional global teams.
Excellent communication, organizational, and problem-solving skills, with the ability to prioritize tasks and meet deadlines in a dynamic environment.
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.

Nice To Haves

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

Responsibilities

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.