III, Analytical Development

Genezen•Lexington, MA

3d•$85,000 - $130,000

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. WORKING AT GENEZEN 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. JOB SUMMARY Lead the establishment of methods in the Analytical Development (AD) and Quality Control lab from the bench. This individual will be accountable for the establishment, development, and qualification of analytical methods and method transfer to QC. The individual will also support training of QC team on methods and validation activities as appropriate. 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 method development in the biophysical characterization of AAV particles with an emphasis on HPLC based methodology using various detectors including UV-Vis, CAD, and MALS detectors. Prior expertise in use of MALS and CAD detectors is a strict requirement for this position. This position will be filled at the Scientist I, II, or III level, dependent upon the qualifications and experience of the successful candidate.

Requirements

BS in scientific/technical discipline
2-12 years of 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
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

Responsibilities

Expert in HPLC based methodology development and establishment using MALS and CAD detectors for use in the characterization of AAV vectors.
Must be able operate HPLC associated equipment including equipment troubleshooting as required without support.
Familiarity with OpenLab and Empower software packages for the analysis of HPLC based readouts.
Maintain familiarity with current equipment used in Analytics lab
Help management evaluate new technology and bring new platforms in-house
Qualify 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
Other duties as assigned