Sr. Scientist - 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

The Sr Scientist / Technical Lead Analytical Development will be part of the Process Development group, reporting to the Director of Process Development.

He / She focuses on defining and managing the execution of the analytical development strategies and activities across the program / project lifecycle supporting process development and characterization.

The Sr Scientist owns the analytical development assay lifecycle both from a technical and planning standpoint. Responsibilities will include scientific review and oversight of assay design, development, qualification, troubleshooting, and transfer as well as product characterization.

The Sr Scientist will also be responsible for ensuring oversight of the analytical project timelines, and alignment across different teams and contributors to the analytical development efforts.

ESSENTIAL JOB FUNCTIONS

The Sr. Scientist / Technical Lead will be a contributor to the activities of the Process Development group with specific attention toward the critical activities of the team :

• Developing, qualifying and transfer of client / product-specific assays to be used for in-process, release testing, and process characterization
• Providing analytical support to Upstream and Downstream process development team activities by ensuring consistent and timely execution of standardized platform product characterization assays, including data review, storage and trending
• Facilitating integration of new products into Genezen analytical platforms, to ensure timely progress of transfers and timelines

Other Key Responsibilities & Functions :

• Owns the development lifecycle (method development, qualification, transfer), planning and timelines for multiple projects
• Responsible for analytical strategy and timeline definition and monitoring in line with overall project timelines and functional team input
• Oversees the project from an analytical standpoint as core member of the project team, and has key interactions with Upstream & Downstream process development, supply chain, and external consultants and vendors
• Communicates and aligns with internal and external stakeholders' activities relevant to specific projects planning and progression
• Prepare data overviews and reports, including interpretation of results. Proposes next steps in experimental design including rational and timelines
• Presents project updates, progress and results to internal and external stakeholders
• Drafts or reviews laboratory and technical documentation such as SOPs, protocols, reports, position papers and memos
• Assist team members with their planning and coordination of activities
• Ensure all laboratory activities are performed according to applicable procedures to ensure a safe working environment and high data quality
• Provide improvement suggestions and enforce improvement implementation

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule 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

MSc with 10+ years of industrial experience in a Life Sciences related field (biochemistry, molecular biology, biotechnology)

Essential

PhD with 6+ years of industrial experience in a Life Sciences related field (biochemistry, molecular biology, biotechnology)

Preferred

ON-THE-JOB EXPERIENCE

Broad knowledge of the pharmaceutical industry, including in depth operating knowledge of functions and assays relevant to viral vector therapeutic analytical within drug development processes

Essential

Demonstrated experience in project management skills and leadership experience, including setting timelines, alignment and helping others meet timelines

Essential

SKILLS / ABILITIES

Thorough scientific knowledge and hands-on experience with cell-based assays and bioassays, specifically in vitro potency assays

Essential

Thorough scientific knowledge and hands on experience with relevant molecular biology techniques (e.g. qPCR & dPCR, DNA electrophoresis)

Essential

Thorough scientific knowledge and hands on experience with biochemical analyses (e.g. protein electrophoresis, western blotting, ELISA)

Essential

Thorough scientific knowledge in the process of assay design, assay development and trouble shooting

Essential

Experience in viral vaccines or gene therapy

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

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

• Paid vacation days, amount based on tenure
• Paid sick time
• 9 observed holidays + 1 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.