Scientist I​/II​/III, Analytical Development

Scientist I/II/III, Analytical Development Job Summary

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.

Lead the establishment of methods in the Analytical Development (AD) and Quality Control lab from the bench. This individual will be accountable for the establishment, development, and qualification of analytical methods and method transfer to QC. The individual will also support training of QC team on methods and validation activities as appropriate. The person is expected to work collaboratively with the team to establish and implement best regulatory, laboratory practices and to lead the execution of complex experiments.

The position requires expertise in method development in the biophysical characterization of AAV particles with an emphasis on HPLC based methodology using various detectors including UV‑Vis, CAD, and MALS detectors. Prior expertise in use of MALS and CAD detectors is a strict requirement for this position.

This position will be filled at the Scientist I, II, or III level, dependent upon the qualifications and experience of the successful candidate.

Genezen operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.

• Expert in HPLC based methodology development and establishment using MALS and CAD detectors for use in the characterization of AAV vectors.
• Must be able to operate HPLC associated equipment including equipment troubleshooting as required without support.
• Familiarity with Open Lab and Empower software packages for the analysis of HPLC based readouts.
• Maintain familiarity with current equipment used in the Analytics lab.
• Help management evaluate new technology and bring new platforms in-house.
• Qualify analytical methods to support cGMP testing.
• Help 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, assisting in project planning.
• 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.
• Maintain high quality deliverables and open communication, creating a collaborative working environment.
• Contribute to collaborative, creative and rigorous culture of scientific discovery.
• Provide weekly reports to department head.

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

• BS in scientific/technical discipline.
• 2‑12 years of CRO/CDMO experience in design, development, and execution of bioanalytical methods (e.g., method development, qualification, validation and transfer).
• Direct hands on experience with MALS and CAD detectors in AAV analytics.
• Expertise in the biophysical characterization of AAV particles and associated impurities.
• Experience with LC‑MS based assay development.
• Experience with documentation and reporting of results using electronic lab notebooks.
• People training and leadership skills.
• Ability to maintain multiple projects and timelines.
• Excellent verbal and written communication skills.
• Extremely high levels of initiative, adaptability, tenacity and troubleshooting skills.

Not Applicable

Full‑time

Food and Beverage Services

$85,000 – $130,000 per year

Genezen is an Equal Opportunity Employer. Genezen participates in EVerifi. Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.