Scientist I​/II, 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.

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.

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 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 the biophysical characterization of AAV particles with an emphasis on HPLC based methodology using various detectors including UV‑Vis, CAD, and MALS detectors.

• Expert in HPLC based methodology development and establishment including with the use of CAD and MALS detectors for use in the characterization of AAV vectors.
• Expected to be able to operate HPLC associated equipment including equipment troubleshooting as required.
• Familiarity with Open Lab software for the analysis of HPLC based readouts.
• Maintain familiarity with other current analytical and bioassay methods, including Flowcytometry, ELISA, qPCR and ddPCR based assays in Lenti, Retro and AAV platforms.
• Maintain familiarity with current equipment used in Analytics lab.
• Help management evaluate new technology and bring new platforms in‑house.
• Qualify/Validate 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 in 1:1 environment.

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

BS in scientific/technical discipline.

2–4 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: HPLC using UV‑Vis, CAD, and MALS detectors, qPCR, ddPCR, ELISA, cell‑based assays (potency, infectivity, etc.) and flow cytometry‑based assays.

Expertise in the biophysical characterization of AAV particles and associated impurities.

Experience with…