Senior QC Associate, Potency

Job Summary

The Quality Control Specialist (Lead) within the Operations group of the Quality Control Organization supports all bioassay activities required of HTO QC, focusing on testing and execution of assignments as assigned by site operations, QC specialists, and/or QC management. The QC Specialist plays a meaningful role in maintaining and improving functional operations within QC, enabling the organization to support all manufacturing and business testing needs.

This role’s focus is to serve as the QC department’s subject matter expert in Quality Control Bioassay Operations processes and provide guidance, mentorship, and training to junior analysts. This role works with QC leadership and cross‑functional partners on QC-related projects and continuous improvement initiatives.

Coordinate scheduling, logistics, and day‑to‑day testing activities of analysts and provide overall technical and logistical guidance within their QC focus group/testing pod. Implementing, modifying, and enforcing Quality Control policies, procedures, specifications and testing methods consistent with cGMP, regulations, appropriate compendium, and Roche/Genentech standards, policies, plans, objectives and procedures. Routine performing, and reviewing a variety of Bioassays in the Quality Control organization in support of In‑process, drug product, finished product, raw materials and incoming inspection, and environmental monitoring testing in a cGMP environment.

Interprets data, troubleshoots assay failures and equipment issues while adhering to strict guidelines on cGMP documentation. Supports method validation activities, performance qualifications, method transfers, discrepancy/out‑of‑specification investigations and collaborates with stakeholders to identify improvement opportunities in technology and business processes. Ensure maintenance and calibration of laboratory equipment and systems. Support during cGMP audits and Health Authority inspections as needed, and follow up on any corrective measures.

• GMP QC
  :
  Significant experience in executing cell culture and bioassays in a GMP regulated QC laboratory according to standard operating procedures.
• Assay Execution & Troubleshooting
  :
  Demonstrated expertise in developing, troubleshooting, and executing mechanism‑of‑action reflective biological assays, including:
  • Cell‑based assays (reporter gene, cell proliferation, cytotoxicity, apoptosis, ADCC/CDC).
  • Immunoassays and binding methodologies.
  • Various mammalian cell culture techniques (suspension and adherent cell lines, generation of cell banks).
• Analytical Method Lifecycle
  :
  Proven experience in method validation, method transfer (internal and external/CMO), and routine lifecycle management of potency assays for commercial release and stability testing.
• Data Analysis & Statistics
  :
  Proficiency in statistical evaluation of bioassays, including parallel line analysis, 4‑PL/5‑PL curve fitting, and assessing assay capabilities.
• Systems & Software
  :
  Advanced proficiency with industry‑standard software and systems, including Soft Max Pro, JMP (or similar statistical software), LIMS, ELN, and QMS platforms (e.g., Track Wise, Veeva Vault).

• Bachelor’s Degree with 5‑7 years experience working in a cGMP or similarly regulated environment in the pharmaceutical or science industry.
• 3‑5 years experience with a Master’s Degree or 0‑2 years experience with PhD/JD.
• Minimum of 2 years working directly within a highly regulated commercial Quality Control (QC) or cGMP environment.
• Extensive experience leading and authoring complex laboratory investigations, including OOS, OOT, Deviations, and CAPAs using root cause analysis methodologies.
• Exceptional ability to author, review, and approve SOPs, analytical test methods, validation protocols, and summary reports.
• Strict adherence to ALCOA+ principles and uncompromising commitment to data integrity and compliance in a commercial setting.
• Significant potency (bioassay) experience with sound knowledge of GMP and considerable analytical/QC experience.
• Professional level written and oral communication skills; ability to organize and present information informally and…