Sr. Scientist, Analytical Development

About the role

Lead the establishment of methods in the Analytical Development (AD) and Quality Control lab from the bench. This individual will be accountable for development and validation of analytical and QC assays, equipment specification and selection, and the direction of analytical method transfer from the analytical development lab to the QC lab while operating under cGMP standards. The position requires expertise in potency and other cell-based assays, ddPCR/qPCR, and ELISA. Considerable expertise with experimental design toward method qualification and validation per ICH guidelines in a phase-appropriate manner is expected, along with technical writing of protocols, SOPs, and technical reports. Experience with biophysical characterization methods including HPLC, LC-MS, CE-SDS, and direct line management is required.

Responsibilities

• Develop and validate analytical and QC assays, including AAV assay development
• Design method qualification/validation experiments per ICH guidelines
• Set specifications for complex biologics
• Develop potency methods and ddPCR/qPCR assays from primer design to implementation
• Develop ELISA assays and HPLC-based methodologies, including CAD and MALS detectors for AAV vector characterization
• Maintain familiarity with current analytical and bioassay methods, including flow cytometry
• Evaluate and implement new technologies and platforms in-house
• Qualify/validate analytical methods to support cGMP testing
• Facilitate tech transfer of analytical and bioassays between clients, AD lab, and QC lab
• Supervise, train, and mentor AD Associates and AD Technicians
• Collaborate with process development, manufacturing, quality assurance, and quality control departments
• Assist in project planning and establish electronic record-keeping systems (e.g., LIMS or ELN)
• Analyze regulatory guidance documents relevant to biological product testing
• Advise management on potential quality exposures or business opportunities
• Execute research timelines to meet program and corporate objectives
• Maintain high-quality deliverables and open communication in a collaborative environment
• Provide weekly reports to the department head

Requirements

• BS in a scientific/technical discipline (PhD, Master’s, or Bachelor’s with commensurate experience)
• 5-6 years post-graduation experience (PhD), 6-8 years (Master’s), or 8-12 years (Bachelor’s)
• 2-4 years of CRO/CDMO experience in bioanalytical method development, qualification, validation, and transfer
• Expertise in molecular biology for AAV particle characterization and associated impurities
• Experience with electronic lab notebooks for documentation and reporting
• People training and leadership skills
• Ability to manage multiple projects and timelines
• Excellent verbal and written communication skills
• High levels of initiative, adaptability, tenacity, and troubleshooting skills

Skills

• Potency and cell-based assays
• ddPCR/qPCR (primer design, optimization, implementation)
• ELISA assay development
• HPLC-based methodology (UV-Vis, CAD, MALS detectors)
• Biophysical characterization methods (LC-MS, CE-SDS)
• Flow cytometry
• Technical writing (protocols, SOPs, reports)
• Regulatory compliance (ICH guidelines, cGMP)

Benefits

• Paid vacation days (amount based on tenure)
• Paid sick time
• 10 observed holidays + 2 floating holidays + 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 and personal accident insurance
• Voluntary disability, universal life, and personal accident insurance
• Accidental Death & Dismemberment (AD&D) Insurance

Pay

The annual salary range for the Senior Scientist is $120,000–$150,000.

Work Environment

• Frequently required to work in a BSL2 environment with personal protective equipment/aseptic gowning
• Occasionally exposed to moving mechanical parts, toxic or caustic chemicals, and hazardous waste
• Frequently required to stand, sit, use hands, reach with hands and arms
• Occasionally required to walk, climb, balance, 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 ability to adjust focus
• Frequently required to communicate via talking, hearing, telephone, and email

About Genezen

Genezen provides process development, GMP viral vector production, and cell transduction for gene and cell therapy clinical trials. We empower employees to be innovative, collaborative problem-solvers in a fast-growing company where every individual contributes to success. Our locations include Fishers, Indiana (a suburb of Indianapolis named the #1 place to live in the U.S. by Money Magazine in 2017) and Lexington, Massachusetts (a historic suburb near Boston known for its cultural heritage and community pride).

Core Values

• Committed to Science: Scientific excellence, data-driven decisions, and innovation to advance healthcare
• Urgency in Action for the Patients: Accelerating partners' programs to deliver timely treatments
• Resilience & Grit in Operations: Overcoming challenges and learning from failures
• Execute with Excellence & Integrity: Delivering quality results and upholding ethical principles
• Solutions Driven for Our Partners: Proactive, collaborative, and creative problem-solving