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Genezen · 2 months ago

Scientist I/II, Analytical Development

Lexington, MA

Full-time

Onsite

Mid, Senior Level

$85K/yr - $115K/yr

2+ years exp

Genezen is a company focused on gene therapy and the development of GMP viral vectors for clinical trials. The Scientist I/II in Analytical Development will lead the establishment of methods in the lab, focusing on the development and validation of analytical assays while ensuring compliance with cGMP standards.

BiotechnologyGeneticsManufacturing

No H1B

Responsibilities

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 OpenLab 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

Qualification

HPLC methodology developmentBiophysical characterization of AAVBioanalytical method validationOpenLab softwareMass Spectrometry (LCMS)People training skillsTroubleshooting skillsProject managementVerbal communicationWritten communication

Required

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 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