Sr Manager, QC Analytical
The Sr. Manager, Quality Control, Analytical is responsible for the strategic leadership, development, and oversight of the QC Analytical function in support of GMP manufacturing operations and Stability program at Abzena. This role ensures robust analytical testing for raw materials, drug substance, drug product, in-process, release, and stability programs while driving continuous improvement, compliance, and operational excellence.
The Sr. Manager provides leadership across multiple QC workstreams, including method lifecycle management, investigations, regulatory readiness, and cross-functional alignment. This individual plays a key role in scaling QC capabilities, supporting client programs, and ensuring inspection readiness.
Responsibilities
Leadership & Strategy
- Provide strategic direction and leadership for QC Analytical operations across projects and sites.
- Build, develop, and lead high-performing teams, including managers, scientists, and analysts.
- Drive organizational design, workforce planning, and succession planning for QC.
- Establish department goals aligned with company objectives and ensure execution.
Operational Oversight
- Oversee all QC analytical activities, including testing, scheduling, and sample lifecycle management.
- Ensure efficient lab operations, capacity planning, and resource allocation across programs.
- Lead forecasting and prioritization of analytical testing to support manufacturing and client timelines.
- Oversee contract testing organizations (CTOs) and external partners as needed.
Quality & Compliance
- Ensure QC operations are compliant with cGMP, regulatory expectations, and internal quality systems.
- Provide leadership in regulatory inspections, audits, and client interactions.
- Oversee and approve OOS/OOT investigations, deviations, discrepancies, CAPAs, and change controls.
- Ensure inspection readiness and sustained compliance across QC laboratories.
Technical Excellence
- Oversee lifecycle management of analytical methods, including transfer, qualification, validation, and continued verification.
- Provide technical leadership in troubleshooting complex analytical and laboratory issues.
- Ensure robust data integrity practices and data review processes.
- Support CMC activities including regulatory filings and method validation strategies.
Laboratory & Systems Management
- Direct oversight of laboratory infrastructure and support instrumentation lifecycle (qualification, calibration, maintenance) as needed.
- Lead implementation and optimization of QC systems, digital tools, and data trending processes.
- Drive continuous improvement initiatives focused on efficiency, compliance, and scalability.
Cross-functional Collaboration
- Partner closely with Manufacturing, Quality Assurance, and R&D teams.
- Serve as a key stakeholder in program teams and client engagements.
- Support technology transfer activities between Analytical development and QC laboratories.
Talent Development
- Coach, mentor, and develop leaders and team members within QC.
- Promote a culture of accountability, collaboration, and continuous improvement.
- Ensure training programs meet technical, GMP, and safety requirements.
Qualifications
- Bachelor’s degree in biology, Chemistry, or related life sciences (advanced degree preferred).
- 10+ years of experience in GMP-regulated biopharmaceutical QC/analytical environments
- 5+ years of leadership experience, including managing managers or large teams
- Strong experience across product lifecycle (development through commercial manufacturing).
- Deep knowledge of analytical techniques: HPLC/UHPLC, CE, SDS-PAGE, ELISA, FTIR, UV-Vis, and compendial methods.
- Proven experience with method validation, tech transfer, and regulatory inspections.
- Demonstrated success leading complex investigations and driving resolution.
- Strong leadership, decision-making, and organizational skills.
- Experience scaling QC operations and driving process improvements preferred.
- Knowledge of stability programs, data trending, and statistical analysis.
FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
