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

Genezen•Indianapolis, IN

9d•Onsite

About The Position

The 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). This role is accountable for integrating Analytical Development and Quality Control into a unified, phase-appropriate analytical lifecycle that supports both scientific innovation and GMP execution. The position ensures delivery of compliant, scalable, and robust analytical capabilities from development through commercialization while maintaining inspection readiness and data integrity. This role serves as the single point of accountability for analytical science and QC execution, ensuring that development, regulatory expectations, and GMP operations are fully integrated into a scalable, inspection-ready analytical framework.

Requirements

BS in Molecular Biology, Biochemistry, Chemistry or related field
Minimum 4 years in a leadership role
Minimum 8 - 10 years progressive experience in analytical development, quality control, or related discipline within biopharma or CDMO environments
Extensive experience supporting viral vector products across clinical development phases and regulatory submissions
Demonstrated success leading analytical development, method validation, and QC Operations in a cGMP environment
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
Extensive knowledge of cGMP, GLP, FDA, EMA, and ICH requirements.
Excellent communication skills and ability to thrive in fast paced, dynamic environment
Experience with environmental monitoring programs, contamination control, and aseptic manufacturing support.
Familiarity with laboratory systems, LIMS, data integrity principles, and automation technologies.
Proven leadership experience, with a track record of building and managing high-performing teams

Nice To Haves

MS in Molecular Biology, Biochemistry, Chemistry or related field

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.