Associate Director

Sr. Manager/Associate Director, Analytical Development & Quality ControlIndianapolis, INThe field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.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.Strategy & Analytical GovernanceDevelop 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.Analytical Development & Lifecycle ManagementLead 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.Quality Control Operations & StabilityLead 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.Laboratory & Shared Infrastructure GovernanceOwn 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.Microbiology, EM & Contamination ControlServe 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.Regulatory Compliance & Inspection ReadinessEnsure 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.Data Integrity, Systems & Continuous ImprovementOversee 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).Client & Cross-Functional LeadershipAct 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.Organizational LeadershipLead 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.Knowledge, Skills, and ExperienceEducation / Certifications / Licenses - Essential/DesiredBS in Molecular Biology, Biochemistry, Chemistry or related field - EssentialMS in Molecular Biology, Biochemistry, Chemistry or related field - DesiredOn-the-Job ExperienceMinimum 4 years in a leadership role - EssentialMinimum 8 - 10 years progressive experience in analytical development, quality control, or related discipline within biopharma or CDMO environments - EssentialExtensive experience supporting viral vector products across clinical development phases and regulatory submissions - EssentialDemonstrated success leading analytical development, method validation, and QC Operations in a cGMP environment - EssentialSkills / AbilitiesStrong 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 - EssentialExtensive knowledge of cGMP, GLP, FDA, EMA, and ICH requirements. - EssentialExcellent communication skills and ability to thrive in fast paced, dynamic environment - EssentialExperience with environmental monitoring programs, contamination control, and aseptic manufacturing support. - EssentialFamiliarity with laboratory systems, LIMS, data integrity principles, and automation technologies. - EssentialProven leadership experience, with a track record of building and managing high-performing teams - EssentialPhysical DemandsWhile performing the duties of this job, the employee is required to meet the following physical demands:Work EnvironmentFrequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowningRegularly required to work around large machinery and typical utilities seen in pharmaceutical facilitiesOccasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shockOccasionally exposed to extremely loud noise levelsSpending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is requiredMovementFrequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and armsOccasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawlLiftingFrequently lift and/or move up to 10 poundsOccasionally lift and/or move up to 25 poundsVisionFrequently utilize close vision and the ability to adjust focusCommunicationFrequently required to communicate by talking, hearing, using telephone and e-mailGenezen's Cures Value-Based CompetenciesCommitted to Science We are committed to scientific excellence, staying current with