Genezen

Genezen

Director, Analytical Development & Quality Control

Indianapolis, IN · Director

Sponsorship not specified$12k-$15kDetected 13 days ago
CompliancePerformance ManagementClinical TrialsGMPFDA RegulatoryqPCRCRISPRFlow CytometryMolecular BiologyProtein AnalysisLeadershipCommunicationMentoring

About the role

  • The 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 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.

Responsibilities

  • Develop and execute the long-term strategy for Analytical Development (AD) and Quality Control (QC) aligned with business objectives and growth plans.
  • Define and maintain the analytical control strategy, including specification setting, method selection, and lifecycle management across development stages.
  • Drive harmonization, scalability, and future-readiness of analytical capabilities.
  • Develop analytical platforms and reference standards supporting viral vector characterization.
  • 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.
  • 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 microbiological controls support product quality and regulatory compliance.

Requirements

  • Minimum 5 years in a leadership role
  • Minimum 12 -15 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
  • Frequently required to stand
  • Occasionally required to walk
  • While performing the duties of this job, the employee is required to meet the following physical demands:

Skills

  • MS in Molecular Biology, Biochemistry, Chemistry or related field
  • PhD in Molecular Biology, Biochemistry, Chemistry or related field
  • qPCR and ddPCR
  • Flow cytometry
  • Cell-based potency assays
  • Genome integrity assays
  • Empty/full capsid analysis
  • 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 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

Compensation

  • $12k-$15k

Benefits

  • Frequently utilize close vision and the a

Company info

  • The 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.
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This listing is sourced directly from Genezen's careers page and normalized into a canonical job model.