Associate Director, Analytical Development

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

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.