Sr. Scientist, Analytical Development

Genezenlabs; Lexington (MA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Paid vacation days

401(k) plan with company match

Choice of healthcare plans

Job summary

Genezenlabs is seeking a Senior Scientist in Lexington, MA, to lead the Analytical Development and Quality Control lab. This role includes overseeing the development and validation of analytical assays while ensuring compliance with cGMP standards. The successful candidate will work collaboratively across departments to optimize assays and contribute to the establishment of best practices.

Qualifications include a BS in a scientific discipline, 5-12 years of experience, and significant expertise in AAV potency and related bioanalytical methods.

Qualifications

• 5–12 years of relevant experience depending on degree (PhD, Master's, Bachelor's).
• CRO/CDMO experience in bioanalytical methods design and execution.
• Ability to train and manage team members.

Responsibilities

• Lead analytical development and quality control for assays.
• Collaborate with cross-functional teams for technology transfer.
• Supervise and train Analytical Development Associates.

Skills

AAV potency expertise

Method qualification and validation

HPLC and LC-MS techniques

Regulatory compliance knowledge

Excellent communication skills

Education

BS in a scientific/technical discipline

Tools

ddPCR/qPCR

ELISA

Flow cytometry

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: BS in a scientific/technical discipline (Essential)
• On‑The‑Job Experience: 5–6 years post‑graduation (PhD), 6–8 years (Master’s), 8–12 years (Bachelor’s); 2–4 years CRO/CDMO experience in design, development and execution of bioanalytical methods; Expertise in AAV potency, cell‑based assays, ELISA, ddPCR, qPCR, HPLC with UV‑Vis, CAD, MALS detectors, and flow cytometry; Molecular biology expertise in AAV particle characterization; Documentation and reporting using electronic lab notebooks
• Skills: 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

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 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.

Locations

Fishers, Indiana; Lexington, Massachusetts.