Director, Analytical Development & Quality Control
Genezenlabs
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Benefits offered by this job
Job summary
Genezenlabs in Indianapolis is seeking a Director for Analytical Development & Quality Control. This role will provide strategic, scientific, and operational leadership for analytical functions supporting viral vector programs. The candidate will integrate analytical capabilities from development through commercialization, ensuring compliance and data integrity.
Applicants should have a Master's degree and significant leadership experience within biopharma. The position includes a comprehensive benefits package and a unique opportunity to be part of a rapidly growing field.
Qualifications
- Minimum 5 years in a leadership role.
- Minimum 12-15 years experience in analytical development and QC.
- Extensive experience with viral vector products.
Responsibilities
- Develop and execute long-term strategy for Analytical Development.
- Lead QC laboratory operations supporting in-process and release testing.
- Oversee regulatory compliance and ensure continuous inspection readiness.
Skills
Education
Tools
Job description
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.
Manypeople 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 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.
- 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/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.
- MS in Molecular Biology, Biochemistry, Chemistry or related field (Essential)
- PhD in Molecular Biology, Biochemistry, Chemistry or related field (Desired)
- Minimum 5 years in a leadership role (Essential)
- Minimum 12‑15 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)
- Excellent communication skills and ability to thrive in fast paced, dynamic environment (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)
While performing the duties of this job, the employee is required to meet the following 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
- Committed to Science – We are committed to scientific excellence, staying current with industry developments, making data‑driven decisions, and pursuing innovation to advance healthcare.
- Urgency in action for the patients – We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
- Resilience & Grit in operations – We are committed to overcoming challenges, learning from failures, and persistently striving for success.
- Execute with Excellence & Integrity – We are dedicated to delivering quality results and upholding ethical principals.
- Solutions driven for our partners – We are committed to being a proactive, collaborative, creative and open‑minded partner.
- Paid vacation days, amount based on tenure
- Paid sick time
- 10 observed holidays + 2 floating holiday + 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
- Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- This position requires a criminal background check.
- Genezen is an Equal Opportunity Employer.
- Genezen participates in EVerify.
- Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
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