Scientist I, Analytical Development

Job Description

Job Description

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 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 the biophysical characterization of AAV particles with an emphasis on HPLC based methodology using various detectors including UV-Vis, CAD, and MALS detectors.

JOB 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

SPECIAL JOB REQUIREMENTS

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential / Desired

BS in scientific / technical discipline

Essential

ON-THE-JOB EXPERIENCE

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.

Essential

Expertise in the biophysical characterization of AAV particles and associated impurities.

Essential

Experience with documentation and reporting of results using electronic lab notebooks

Essential

SKILLS / ABILITIES

Mass Spectrometry emphasis on LCMS

Desired

People training and leadership skills

Essential

Ability to maintain multiple projects and timelines

Essential

Excellent verbal and written communication skills

Essential

Extremely high levels of initiative, adaptability, tenacity and troubleshooting skills

Essential

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands :

Work Environment

Movement

Lifting

Vision

Communication

GENEZEN'S CURES VALUE-BASED COMPETENCIES

C ommitted to Science

We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

U rgency in action for the patients

We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

R esilience & Grit in operations

We are committed to overcoming challenges, learning from failures, and persistently striving for success.

E xecute with Excellence & Integrity

We are dedicated to delivering quality results and upholding ethical principals.

S olutions driven for our partners

We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS

ADDITIONAL DETAILS

Genezen has operates two locations : one in Fishers, Indiana and the second in Lexington, Massachusetts.

Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum to name just a few reasons why this area is a great place to live.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.