Associate Director, Analytical Development

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.

PURPOSE:

The Associate Director of Analytical Development will be responsible for all facets of analytical development and method qualifications for Genezen in Fishers, IN. This role includes providing strong leadership, guidance, and scientific oversight to the Analytical Development team, encompassing analytical development, method qualifications, and method transfers to Quality Control (QC) testing labs.

This individual is passionate about building teams and establishing well-characterized, controlled, and efficient viral vector testing methods. The role is client-facing and requires strong knowledge of managing multiple programs to ensure efficient resource allocation and execution. The individual will foster cross-functional collaboration with Quality, EHS, and Quality Control departments, while working closely with the CSO on strategic decision-making.

The Associate Director of Analytical Development will direct the planning, execution, and customer interactions related to analytical method development. They will be responsible for developing robust and efficient methods for transfer to QC for testing products manufactured in the GMP facility for early-phase clinical programs. Additionally, this position will develop budgets for labor and capital expenditures and approve all analytical proposals for customers from a delivery perspective.

ESSENTIAL JOB FUNCTIONS/DUTIES:

• Responsible for Building and developing the analytical development teams
• A thought leader in Analytical Sciences and Development.
• Provide strategy, leadership, and scientific direction for development, design and qualification of analytical methods to evaluate LVV, RVV and AAV vector process and characterization.
• Ensure overall project success, identifying and tracking progress against key project milestones.
• The individual will have substantial input toward equipment and technology assessment, integration, automation, and High-throughput system evaluations for viral vector testing.
• Communicate and coordinate implementation of procedural improvement to senior management across the functional areas.
• Continually seek and evaluate development of new potential technologies for rapid testing of AAV, LVV and RV vectors
• Analyze, interpret, and present data to internal and external audiences using various formats.
• Contribute to the support, optimization, and improvements of new methodologies.
• Work as a team with manufacturing, QA, QCA and other departments as needed.
• Contribute to the maintenance of laboratory equipment and laboratory support operations
• As a viral vector analytical SME, support other functions including strategy for testing of raw materials, pre-clinical development, reference standards and assay validations, etc.
• Provide technical oversight and guidance to analytical team.
• Develop and implement analytical strategies to control quality of drug substances and products based on current Good Laboratory Practices (cGLP) and/or Good Manufacturing Practice (cGMP) regulations.
• Assist management in writing work proposals and project estimates for clients
• Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies for supervised employees.

SPECIAL JOB REQUIREMENTS:

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

MS in Molecular Biology, Biochemistry, Chemistry or related field

Essential

PhD in Molecular Biology, Biochemistry, Chemistry or related field

Desired

Minimum 3 years in a leadership role

Essential

Experience in Quality Control testing, and/or assay development for large molecules or Viral Vectors

Essential

Strong ability to plan and troubleshoot Viral Vector analytical methods

Essential

Hands on experience in designing and implementing experiments to evaluate processes, analytical methods and formulations

Strong verbal, written, and interpersonal communication skills as a team player and willing to work in an environment where individual initiative, collaboration and accountability are valued

Essential

Entrepreneurial experience dealing with customers

Essential

Prior experience in creating, building, implementing, and managing a high function Analytical Development Team

Essential

Understanding of guidelines required by FDA, EMEA, and other regulatory bodies

Essential

Excellent communication skills and ability to thrive in fast paced, dynamic environment

Essential

Capable of maneuvering through abstract and concrete variables in situations where only limited standardization exists

Essential

Proven leadership experience, with a track record of building and managing high-performing teams

Essential

Proficiency using JMP, Benchling and statistical software, or equivalent

Essential

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to work in a BSL 2/3 environment with personal protective equipment.
• While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
• In the performance of the duties of this job the employee is required to communicate using telephone and e-mail.

GENEZEN'S CURES VALUE-BASED COMPETENCIES

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.

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 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.