Sr. Scientist, Analytical Development

genezenlabs

Lexington, MA · Lexington · United States

Posted May 11, 2026

Full-time
Analytical Development

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 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.

JOB 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

SPECIAL JOB 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

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES	Essential/Desired
BS in scientific/technical discipline	Essential
ON-THE-JOB EXPERIENCE
5-6 years experience post graduation (with PhD), 6-8 years experience post graduation (with Masters), 8-12 years experience post graduation (with Bachelors)	Essential
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.	Essential
Expertise in molecular biology in the characterization of AAV particles and associated impurities.	Essential
Experience with documentation and reporting of results using electronic lab notebooks	Essential
SKILLS / ABILITIES
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

Pay Range:

The annual salary range for the Senior Scientist is $120,000-$150,000.

Work Environment

Frequently required to work in BSL2 environment with personal protective equipment/aseptic gowning
Occasionally exposed to moving mechanical parts, toxic or caustic chemicals, hazardous waste, and similar hazards associated with pharmaceutical lab facilities

Movement

Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

Frequently lift and/or move up to 10 pounds
Occasionally lift and/or move up to 25 pounds

Vision

Frequently utilize close vision and the ability to adjust focus

Communication

Frequently required to communicate by talking, hearing, using telephone and e-mail

GENEZEN'S CURES VALUE-BASED COMPETENCIES

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

Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.

Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.

Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS

Paid vacation days, amount based on tenure
Paid sick time
10 observed holidays + 2 floating holiday + 1 volunteer day
401(k) plan with company match up to 6% of salary
Share Appreciation Rights
Choice of several healthcare plans
FSA and HSA programs
Dental & vision care
Employer-paid basic term life/personal accident insurance
Voluntary disability, universal life/personal accident insurance
Accidental Death & Dismemberment (AD&D) Insurance

ADDITIONAL DETAILS

Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
This position requires a criminal background check.
Genezen is an Equal Opportunity Employer.
Genezen participates in EVerify.
Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

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.