Sr. Scientist, Analytical Development

About the role

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.

Responsibilities

• Lead the establishment of methods in the Analytical Development (AD) and Quality Control lab from the bench.
• Develop and validate analytical and QC assays.
• Specify and select equipment.
• Direct analytical method transfer from the analytical development lab to the QC lab while operating under cGMP standards.
• Collaborate with the team to establish and implement best regulatory, laboratory practices.
• Execute complex experiments.
• Work with the team to develop and qualify potency and other cell-based assays, ddPCR/qPCR, and ELISA.
• Maintain familiarity with biophysical characterization methods including HPLC, LC-MS, CE-SDS etc.
• Support the establishment of electronic record keeping systems for site; e.g. LIMS or ELN.
• Analyze regulatory authorities' programs, guidance documents, and activities in areas relevant to testing of biological products.
• Work as a team with process development, manufacturing, quality assurance and quality control departments as needed.
• Advise site and quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
• Execute research timelines to meet program and corporate objectives.
• Deal with abstract and concrete variables in situations where only limited standardization exists.
• Contribute to collaborative, creative and rigorous culture of scientific discovery.
• Provide weekly reports to department head in 1:1 environment.

Requirements

• Experience with AAV assay development is critical.
• Expert in method qualification/validation experimental design per ICH guidelines.
• Expert in potency method development.
• Expert in ddPCR/qPCR from primer design and optimization to implementation.
• Expert with ELISA assay development.
• Experience with HPLC based methodology development and establishment including with the use of CAD and MALS detectors for use in the characterization of AAV vectors.
• Maintain familiarity with other current analytical and bioassay methods, including Flow cytometry.
• Help management evaluate new technology and bring new platforms in-house.
• Qualify/validate analytical methods to support cGMP testing.
• Facilitate tech transfer of analytical and bioassays from clients to AD lab and from AD lab to QC lab.
• Supervise and train AD Associates and AD Technicians and work closely with other departments.

Qualifications

• BS in scientific/technical discipline.
• Essential 2-4 years of CRO/CDMO experience in design, development and execution of bioanalytical methods (i.e. method development, qualification, validation and transfer).
• Methods include, but are not limited to: Potency for AAV vectors, cell based assays, ELISA, ddPCR, qPCR, HPLC using UV-Vis, CAD, and MALS detectors, and flow cytometry-based assays.
• Essential Expertise in molecular biology in the characterization of AAV particles and associated impurities.
• Essential Experience with documentation and reporting of results using electronic lab notebooks.

Skills and Experience

• People training and leadership skills.
• Excellent verbal and written communication skills.
• High levels of initiative, adaptability, tenacity and troubleshooting skills.

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.
• 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.

Pay

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

Work Environment

• Frequently required to work in BSL2 environment with personal protective equipment/aseptic gowning.
• Occasionally exposed to moving mechanical parts, toxic or caustic chemicals, hazardous waste, and similar hazards associated with pharmaceutical lab facilities.
• 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.
• Communication: Frequently required to communicate by talking, hearing, using telephone and e-mail.

Additional Details

• 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.
• Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage.
• 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.