Scientist II, Upstream Process Development

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

Direct the development and establishment of processes in Process Development. This individual is accountable for developing a scalable platform for viral vector production processes that minimizes the risk during Process Development to GMP scale-up. The individual will provide technical expertise and leadership in science & technology and requires close collaboration with internal stakeholders.

JOB RESPONSIBILITIES

• Design and execute upstream process development activities and identify opportunities to improve process yield, product safety, and product quality.
• Writes and reviews experimental protocols, batch production records, experimental reports.
• Analyze, review, and communicate data to senior management and team members.
• Be accountable for supporting the establishment of upstream gene therapy drug substance development platform from small scale through intermediate scale (50L) for adeno-associated virus, lentiviral and retroviral vector processes.
• Train and mentor research associates.
• Maintain open communication via one-on-one and team meetings.
• Stay current with relevant technologies and need to be adept at identifying new approaches.
• Responsible for the process transfer activities from/to clients and to in-house manufacturing team(s), such as creation of bill of materials and sampling plan, generation of process description documents, technology transfer reports.Provide process training to MSAT and manufacturing teams and assist with process troubleshooting and deviations during GMP production.
• Maintain external technical relationships and collaborate with equipment and material suppliers.
• Serve as process SME for client-facing and internal programs.
• Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the assigned functional area.

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

BS or MS in biochemistry, chemical engineering

Desired

ON-THE-JOB EXPERIENCE

4-8+ years of relevant industry experience

Essential

Experience with cell culture technologies, molecular biology, upstream processing, and aseptic processing

Essential

Pharmaceutical industry experience in technical support of cGMP manufacturing and/or process development, including experience with Contract Development and Manufacturing Organizations

Desired

Solid foundation in the fundamentals of biochemical engineering, virology and cell biology

Essential

Entrepreneurial experience dealing with customers in product development

Desired

SKILLS / ABILITIES

Working knowledge of Upstream process (Cell culture, Aseptic Technique, bioreactor operations).

Essential

Hands-on experience on complex biologics e.g. gene therapy, transient transfection, baculovirus infection

Desired

Working knowledge of Upstream process (process design and bioreactor scale up, cGMP manufacturing).

Desired

Ability to interface successfully with multi-disciplined teams

Desired

Extremely detail-oriented with strong technical skills & mechanically inclined/knowledge of hand tools

Desired

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

Pay Range: The annual salary range for this position is $100,000-$120,000.

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
• 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.