Associate Director Quality Control Analytics

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
Responsible for driving all aspects of the Analytical Quality Control (QC) laboratory at Genezen. This individual is expected to have strong, hands-on, technical experience of gene therapy cell-based assays as well as characterization assays for viral vectors. This individual provides leadership, scientific and technical expertise for all QC activities, as well as support to Analytical Development for all method qualification/validation activities. The ideal candidate must have in-depth knowledge and experience in a cGMP/ GLP testing lab.
ESSENTIAL JOB FUNCTIONS

• Ensure timely in-process and release testing of early clinical grade biopharmaceuticals
• Maintain familiarity with current analytical and bioassay methods used for characterizing viral vectors (Assays include genome titer by Flow, ELISA, qPCR, ddPCR, genome integrity assay, empty/full particle ratio assay, and cell-based assays)
• Responsible for the Analytical laboratory equipment systems and software (e.g., ddPCR, Flow, etc.) including purchase, calibration, IOPQ activities, etc. to meet the compliance (data integrity) requirements and project timelines.
• Support the Analytical Development team in qualification/validation of analytical methods to support the cGMP manufacturing of viral vectors
• Support the tech transfer of bioassays from clients to cGMP QC testing lab
• Represent QC Analytical in client meetings and programs
• Establish and maintain the stability program
• Oversee LIMS development, implementation, operation, troubleshooting and maintenance
• Responsible for Analytical Lab logistics activities including, but not limited to sample management, test/release schedule, cycle time matrix, capacity management, etc.
• Manage outside contract laboratory relationships, including method qualification/validations, investigations, audits, cost and invoices to meet project timelines and business requirements
• Support OOSs/OOTs and other lab investigations, deviations, CAPAs, change controls, audits, and training
• Analyze regulatory authorities' programs, guidance documents, and activities in areas relevant to testing of cell and gene products
• Develop, implement and present metrics for monitoring of lab operations and stability program
• Participation in regulatory inspections as SME and development of responses to observations
• Responsible for hiring and development of team members, conduct performance review and disciplinary actions.
• Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the QC functional area

SPECIAL JOB REQUIREMENTS

• Working knowledge of viral vector gene therapy guidances including FDA, EMA, and ICH
• Willingness to occasionally work nights and weekends required, with the ability to address unplanned facility situations as they arise
• Criminal background check and drug screen required
• Other duties as assigned

KNOWLEDGE, SKILLS, AND EXPERIENCE
EDUCATION / CERTIFICATIONS / LICENSES
Essential/Desired
BS in a scientific/technical discipline
Essential
MS in a scientific/technical discipline
Preferred
ON-THE-JOB EXPERIENCE
3-5 years of experience in a QC leadership position within the biological industry
Essential
Proven technical leadership and experience in bioanalytical methods (method development, validation and transfer). Methods include but not limited to: ELISA, PCR, qPCR, ddPCR, cell-based assays, and flow cytometry-based assays.
Essential
Familiarity with viral vector release assays
Preferred
Proven lab operations management experience
Preferred
3+ years of cGXP experience
Preferred
SKILLS / ABILITIES
Ability to maintain multiple projects and timelines
Essential
Strong people leadership skills
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 VALUE-BASED COMPETENCIES
Growth Mindset
Believe that skill is developed through dedication and hard work.
Intelligence & talent are just the starting point.
Mistakes are valuable lessons, not shameful indictments.
Flexibility
Adapt rapidly to a quickly changing, CDMO environment.
Respond by constructively creating & impacting opportunity through active participation.
Team Focus
Work together; succeed together; fail together.
Integrity
Do the right thing, on time, every time.
Speak up when needed.
Exercise respect.
Inclusion
Embrace the unique viewpoint of each individual.
Join the ongoing journey to a more inclusive workplace and community where we all help each other get better.
GENEZEN'S BENEFITS

• Paid vacation days, amount based on tenure
• Paid sick time
• 9 observed holidays + 1 floating holiday + 1 volunteer day
• 401(k) plan with company match up to 6% of salary, vested immediately
• 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 is located in Fishers, Indiana.
• 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 is located in Fishers, Indiana, 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 museumto name just a few reasons why this area is a great place to live.