Senior Scientist, Analytical Development

Responsibilities

• Lead the establishment of methods in the Analytical Development (AD) and Quality Control lab
• Develop and validate analytical and QC assays, equipment specification, and selection
• Direct analytical method transfer from the AD lab to the QC lab under cGMP standards
• Execute complex experiments and implement best regulatory and laboratory practices
• Perform AAV assay development and potency method development
• Utilize ddPCR/qPCR, ELISA, and HPLC (including CAD and MALS detectors) for AAV characterization
• Supervise and train AD Associates and Technicians
• Support the establishment of electronic record keeping systems like LIMS or ELN
• Collaborate with process development, manufacturing, QA, and QC departments

Requirements

• BS in scientific/technical discipline with 8-12 years experience, or MS with 6-8 years, or PhD with 5-6 years
• 2-4 years of CRO/CDMO experience in bioanalytical method design, development, and execution
• Expertise in molecular biology for AAV particle characterization
• Experience with ddPCR, qPCR, ELISA, and HPLC
• Experience with electronic lab notebooks
• Proven people training and leadership skills
• Ability to manage multiple projects and timelines

Preferred Qualifications

• Experience with Flow cytometry-based assays
• Familiarity with CE-SDS and LC-MS
• Experience with specification setting for complex biologics

Benefits

• Paid vacation days based on tenure
• Paid sick time
• 10 observed holidays plus 2 floating holidays and 1 volunteer day
• 401(k) plan with company match up to 6%
• Share Appreciation Rights
• Healthcare, dental, and vision plans
• FSA and HSA programs
• Employer-paid basic term life and personal accident insurance

About the Company

Genezen provides process development, produces GMP viral vectors, and provides cell transduction for gene and cell therapy clinical trials to meet the needs of the rapidly growing gene therapy field.