QC Manager

Overview

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

We are seeking a highly experienced Quality Control (QC) Manager to lead cGMP QC operations supporting recombinant proteins and monoclonal antibody (mAb) manufacturing within a world-class biologics CDMO environment. This role is responsible for ensuring the execution, compliance, and continuous improvement of QC testing programs supporting clinical and commercial biologics release, raw materials/in-process testing, and manages a team of qualified QC professionals. This role is highly visible and interfaces directly with Manufacturing, QA, MSAT, Regulatory Affairs, and external clients, serving as a key QC subject matter expert during audits and client meetings. This position requires strong experience in QC laboratory operations and a deep understanding of cGMP/GDP testing requirements.

Responsibilities

_QC Leadership and Operational Management:_

• Lead daily operations of QC Analytical lab supporting biologics testing (mAbs, recombinant proteins, fusion proteins)
• Oversee testing activities for:
• Drug substance and drug product release
• Raw materials and in-process samples
• Reference Standard management
• Stability studies (ICH-compliant programs)
• Testing associated with Qualification/Validation of Test Methods
• Ensure timely execution of testing to support manufacturing schedules and batch disposition
• Drive training programs, scheduling, and technical capability development
• Timely maintenance of calibration, PM, qualification of lab instruments
• Lead daily operations of QC Analytical lab supporting biologics testing (mAbs, recombinant proteins, fusion proteins)
• Provide leadership, mentorship, and develop QC associates (typically 4-6 + team members)
• Communicate departmental goals, priorities, and performance expectations to direct reports
• Drive lean laboratory practices, resource planning, and operational excellence initiatives
• Support strategic planning for new equipment, staff capacity planning, organizational structure, and resource requirements.
• Improve turnaround time (TAT), right-first-time execution, and lab efficiency
• Maintain accurate and current release/stability inventory records, testing schedules, and timely issuance of associated CoA’s and summary sheets.
• Represent QC analytical in internal meetings, client meetings, audits, and cross-functional discussions related to stability and reference standards.
• Author and/or review deviations, investigations, CAPAs, change controls, and risk assessments related to stability and reference standard programs.
• Support or lead investigations involving OOS, OOT, non-conformances, and laboratory events.
• Review analytical data packages, perform data trending, and provide troubleshooting support for complex laboratory issues.
• Occasional travel may be required between Abzena sites, including San Diego, California and Bristol, Pennsylvania.

Qualifications

• Bachelor’s degree or higher in Chemistry, Biology, or related Life Sciences discipline
• Minimum 10 years of experience in QC GMP pharmaceutical or biotechnology laboratories within a cGMP-regulated environment
• Minimum 5–6 years of people management experience in QC laboratory settings
• Extensive knowledge of HPLC, ELISA, Capillary Electrophoresis (CE), cIEF (Maurice platform), UV-Vis, cell-based potency assay, and compendial methods.
• Knowledge of ICH, EP, USP, and FDA guidelines relating to method development, qualification/validation, and stability studies.