Senior Scientist, Analytical Development

Genezen•Lexington, MA

18h•Onsite

About The Position

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. 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 potency and other cell based assays, ddPCR/qPCR, and ELISA. Considerable expertise with experimental design toward method qualification and validation per ICH guidelines in a phase appropriate manner. Considerable expertise with technical writing of protocols, SOPs, and technical reports. Experience with biophysical characterization methods including HPLC, LC-MS, CE-SDS etc. Direct line management experience is required.

Requirements

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
BS in scientific/technical discipline
5-6 years experience post graduation (with PhD), 6-8 years experience post graduation (with Masters), 8-12 years experience post graduation (with Bachelors)
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: Potency for AAV vectors, cell based assays, ELISA, ddPCR, qPCR, HPLC using UV-Vis, CAD, and MALS detectors, and flow cytometry-based assays.
Expertise in molecular biology in the characterization of AAV particles and associated impurities.
Experience with documentation and reporting of results using electronic lab notebooks

Responsibilities

Experience with AAV assay development is critical
Expert in method qualification/validation experimental design per ICH guidelines
Experience with specification setting for complex biologics
Expert in potency method development
Expert in ddPCR/qPCR from primer design and optimization to implementation
Expert with ELISA assay development
Experience in HPLC based methodology development and establishment including with the use of CAD and MALS detectors for use in the characterization of AAV vectors
Maintain familiarity with other current analytical and bioassay methods, including Flow cytometry
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