Director, Analytical Development & Quality Control

Job Description

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.

WORKING AT GENEZEN

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.

JOB SUMMARY

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.

ESSENTIAL JOB FUNCTIONS

Strategy & Analytical Governance

• 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.

Analytical Development & Lifecycle Management

• 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.

Quality Control Operations & Stability

• 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.

Laboratory & Shared Infrastructure Governance

• 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.

Microbiology, EM & Contamination Control

• 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.

Regulatory Compliance & Inspection Readiness

• 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.

Data Integrity, Systems & Continuous Improvement

• 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).

Client & Cross-Functional Leadership

• 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.

Organizational Leadership

• 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.

KNOWLEDGE, SKILLS, AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

MS in Molecular Biology, Biochemistry, Chemistry or related field

Essential

PhD in Molecular Biology, Biochemistry, Chemistry or related field

Desired

ON-THE-JOB EXPERIENCE

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

SKILLS / ABILITIES

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

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• 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

Movement

• 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

Lifting

• Frequently lift and/or move up to 10 pounds
• Occasionally lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

GENEZEN'S CURES VALUE-BASED COMPETENCIES

C ommitted to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

U rgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

R esilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.

E xecute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.

S olutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS

• 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

ADDITIONAL DETAILS

• 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.

Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.

Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.