Analytical Development Scientist — AAV HPLC Expert

Genezen; Lexington (MA); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Paid vacation days

401(k) plan with company match up to 6

Health insurance plans

FSA and HSA programs

Life insurance

Job summary

Genezen, based in Lexington, MA, seeks a Scientist I to lead method establishment in Analytical Development and QC for biophysical characterization of AAV particles using HPLC with CAD and MALS detectors. You will validate analytical methods, shepherd tech transfer, and work under cGMP with cross-functional teams.

Requires 2–4 years CRO/CDMO bioanalytical experience, hands-on MALS/CAD, LC-MS, and ELN/LIMS familiarity; strong leadership and communication skills are essential.

Qualifications

• 2-4 years CRO/CDMO experience in design, development and execution of bioanalytical methods (i.e. 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

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.
• Operate HPLC associated equipment including equipment troubleshooting as required.
• Extensive experience with the use of ASTRA software.
• 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.
• Assist with training AD Associates and other team members where needed 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
• 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
• 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

Skills

HPLC

CAD detector

MALS detector

AAV analytics

ASTRA software

OpenLab

qPCR

ddPCR

ELISA

LC-MS

Leadership

Education

BS in scientific/technical discipline

Tools

ASTRA software

OpenLab software

LIMS

ELN

Job description

Genezen, based in Lexington, MA, seeks a Scientist I to lead method establishment in Analytical Development and QC for biophysical characterization of AAV particles using HPLC with CAD and MALS detectors. You will validate analytical methods, shepherd tech transfer, and work under cGMP with cross-functional teams.

Requires 2–4 years CRO/CDMO bioanalytical experience, hands-on MALS/CAD, LC-MS, and ELN/LIMS familiarity; strong leadership and communication skills are essential.