Analytical Development Scientist

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

We are looking for someone with high emotional intelligence and is comfortable working closely across the team to join us in facilitating the production of viral vectors. The Scientist role will be responsible for developing, implementing and qualifying analytical methods in addition to sample testing. The role will require close collaboration with Process Development and Quality Control as well as a flexible mindset to adjust to shifting dynamics within the organization.

ESSENTIAL JOB FUNCTIONS

Develop, optimize and standardize analytical methods for viral vector characterization, including Lentiviral (LVV), Retroviral (RVV) and Adeno-associated Virus (AAV) vectors.

Execute assays involved in viral vector characterization using modalities like flow cytometry, ddPCR, ELISA and cell culture.

Assist with in-lab and out of lab (e.g., report writing) activities to qualify assays per ICH guidelines.

Plan and execute analytical timelines to meet program and corporate objectives.

Implement best laboratory practices to maintain efficiency, consistency and accuracy of work performed.

Train new staff members and fellow employees in designated processes.

Ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory standards.

Maintain appropriate documentation of processing activities, including written and electronic data.

Assist with sample management for process development and clients.

Handle and track laboratory materials and inventory.

Help engage with new technology evaluations and incorporate new platforms.

Perform routine lab maintenance and maintenance of laboratory equipment.

Deal with abstract and concrete variables in situations where only limited standardization exists.

Contribute to a collaborative, creative and rigorous culture of scientific excellence.

SPECIAL JOB REQUIREMENTS

Adaptability in schedules is highly required as work schedules may change based on business needs.

Intent to work with the manager on meeting the company mission, vision and values to achieve department goals.

Criminal background check required.

Other duties as assigned.

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

BS in a scientific discipline

Essential

PhD in a scientific discipline

Desired

ON-THE-JOB EXPERIENCE

BS with 5-7 years of CRO/CDMO or pertinent industry experience in bioanalytical methods (development, qualification and transfer)

Essential

PhD with 0 – 2 years of pertinent experience

Essential

Familiarity with aseptic technique and cell culture

Essential

Experience with PCR methods

Essential

Experience with flow cytometry

Desired

Experience with ELISAs

Desired

Proven assay qualification and validation experience

Desired

3+ years of cGXP experience

Desired

Experience with documentation and reporting of results using electronic lab notebooks

Desired

SKILLS / ABILITIES

Essential/Desired

Strong people leadership skills

Essential

Ability to interpret and analyze data, define problems, establish facts, draw valid conclusions and make decisions

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

Frequently required to work in a BSL-2 environment with personal protective equipment/aseptic gowning

Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities

Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock

Occasionally exposed to extremely loud noise levels

Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required

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, vested immediately

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.

Full-time