Sr. Manager/Associate Director, Analytical Development & Quality Control

About the role

Genezen provides process development, GMP viral vector production, and cell transduction for gene and cell therapy clinical trials. This role—Senior Manager/Associate Director, Analytical Development & Quality Control—provides strategic, scientific, and operational leadership for analytical development and QC functions supporting viral vector programs (AAV, LVV, RVV). The position is accountable for integrating Analytical Development and Quality Control into a unified, phase-appropriate analytical lifecycle that supports both scientific innovation and GMP execution, ensuring delivery of compliant, scalable, and robust analytical capabilities from development through commercialization while maintaining inspection readiness and data integrity.

Responsibilities

• Develop and execute the long-term strategy for Analytical Development (AD) and Quality Control (QC) aligned with business objectives and growth plans.
• Establish and govern the end-to-end analytical lifecycle, ensuring alignment between AD and QC in a shared laboratory environment.
• Define and maintain the analytical control strategy, including specification setting, method selection, and lifecycle management across development stages.
• Translate organizational goals into capability roadmaps (platforms, automation, digital systems, laboratory infrastructure).
• Drive harmonization, scalability, and future-readiness of analytical capabilities.
• Lead analytical method development, qualification, validation, transfer, and lifecycle management in alignment with ICH Q2/Q10/Q14 principles.
• Establish robust method transfer processes, including acceptance criteria, readiness assessments, and ongoing performance monitoring.
• Develop analytical platforms and reference standards supporting viral vector characterization.
• Define and govern sampling strategies to ensure representative and compliant testing.
• Lead QC laboratory operations supporting in-process, release, and stability testing.
• Provide technical decision authority for analytical readiness, method suitability, and QC support of batch disposition.
• Oversee stability strategies, including protocol design, trending, and shelf-life justification.
• Direct investigations (OOS, OOT, deviations) and ensure effective CAPA implementation.
• Ensure QC operations maintain appropriate independence and objectivity in support of quality decisions.
• Own governance of shared laboratory infrastructure, including equipment lifecycle management, scheduling prioritization, and resource allocation.
• Ensure appropriate segregation and controls for GMP and non-GMP activities within shared laboratory spaces.
• Serve as SME for aseptic processing, contamination control, and microbiological monitoring.
• Oversee environmental monitoring programs, trending, and control strategies.
• Ensure microbiological controls support product quality and regulatory compliance.
• Ensure compliance with cGMP, GLP, FDA, EMA, and applicable regulatory requirements.
• Serve as primary SME during regulatory inspections and client audits for analytical and QC functions.
• Support regulatory filings, responses, and analytical justification strategies.
• Maintain continuous inspection readiness across laboratory operations.
• Oversee LIMS, analytical systems, and data integrity (ALCOA+, Part 11) across all laboratory functions.
• Implement digital solutions, automation, and process improvements to enhance efficiency and compliance.
• Establish and monitor performance metrics (e.g., turnaround time, right-first-time, deviation trends).
• Act as executive scientific partner for clients and internal stakeholders.
• Drive alignment across Process Development, Manufacturing, QA, and RA on analytical strategy and readiness.
• Support proposals, scope definition, and client program execution.
• Lead analytical aspects of technology transfer and commercialization.
• Lead a hybrid organization with direct oversight of QC and indirect leadership of AD via scientific leads.
• Build and develop high-performing teams through coaching, performance management, and succession planning.
• Establish a culture of scientific excellence, accountability, and continuous improvement.

Requirements

• BS in Molecular Biology, Biochemistry, Chemistry or related field (essential).
• MS in Molecular Biology, Biochemistry, Chemistry or related field (desired).
• Minimum 4 years in a leadership role (essential).
• Minimum 8–10 years progressive experience in analytical development, quality control, or related discipline within biopharma or CDMO environments (essential).
• Extensive experience supporting viral vector products across clinical development phases and regulatory submissions (essential).
• Demonstrated success leading analytical development, method validation, and QC Operations in a cGMP environment (essential).
• Strong understanding of analytical methods used for viral vector characterization including: qPCR and ddPCR, ELISA, Flow cytometry, Cell-based potency assays, Genome integrity assays, Empty/full capsid analysis (essential).
• Extensive knowledge of cGMP, GLP, FDA, EMA, and ICH requirements (essential).
• Experience with environmental monitoring programs, contamination control, and aseptic manufacturing support (essential).
• Familiarity with laboratory systems, LIMS, data integrity principles, and automation technologies (essential).
• Proven leadership experience, with a track record of building and managing high-performing teams (essential).

Skills

• Excellent communication skills and ability to thrive in a fast-paced, dynamic environment.

Physical Demands

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning.
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities.
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock.
• Occasionally exposed to extremely loud noise levels.
• Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required.
• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms.
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
• Frequently lift and/or move up to 10 pounds.
• Occasionally lift and/or move up to 25 pounds.
• Frequently utilize close vision and the ability to adjust focus.
• Frequently required to communicate by talking, hearing, using telephone and e-mail.

Benefits

• Paid vacation days, amount based on tenure.
• Paid sick time.
• 10 observed holidays + 2 floating holidays + 1 volunteer day.
• 401(k) plan with company match up to 6% of salary.
• Share Appreciation Rights.
• Choice of several healthcare plans.
• FSA and HSA programs.
• Dental & vision care.
• Employer-paid basic term life/personal accident insurance.
• Voluntary disability, universal life/personal accident insurance.
• Accidental Death & Dismemberment (AD&D) Insurance.

About Genezen

Genezen operates two locations: Fishers, Indiana (a suburb of Indianapolis) and Lexington, Massachusetts (northwest of Boston). Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety, and entrepreneurship. Lexington is renowned for its historic New England charm, cultural heritage, and vibrant community.