Sr/Principal Scientist - Upstream Process Development

About the role

The Sr./Principal Scientist, Upstream Process Development will be part of the Process Development Group reporting to the Director of Process Development. This role includes direct management responsibility for a team of Scientists and Research Associates. The Sr/Principal Scientist is responsible for upstream process development, characterization, technology transfer, and GMP manufacturing technical support. This individual will lead or contribute as a core member of various cross-functional teams and interact extensively with other departments, including Analytical Development, Manufacturing, Engineering, and MSAT. This is a client-facing position with regular interaction with partners, including external presentations, driving technical discussions, and program strategy.

Responsibilities

• Provides technical oversight and strategic input for upstream viral vector drug substance development activities.
• Leads, proposes, manages, and coordinates activities on platform improvement/continuous projects in USP labs.
• Leads, manages, and supports late-stage development by identifying tasks, planning, monitoring progress of deliverables, and generating protocols and reports for scale-down model qualification, process characterization, and scale-down model process validation studies.
• Leads and supports technology transfer activities at the pilot plant, including performing experiments, focusing on scale-up platform processes, process improvements, process characterization at scale, bills of materials, and sampling plans.
• Provides MSAT and manufacturing technical upstream SME support for process troubleshooting, manufacturing data analysis, root cause analysis, and deviations during GMP production, including change controls, CAPAs, CCRs, and other Quality Systems documentation.
• Designs and outlines experimental plans to meet defined Genezen and client objectives; analyzes and reviews experimental results and data.
• Performs, optimizes, and maintains linear scale-down models.
• Writes, reviews, and approves electronic lab notebooks (ELNs) entries, experimental protocols, development reports, process descriptions, and scientific reports.
• Presents project progress and results internally to cross-functional teams and externally to clients/stakeholders.
• Maintains robust communication with all relevant functions impacted by or impacting Upstream Process Development.
• Coordinates and supervises activities in the USP labs, including managing engineers, bioprocess technologists, co-op students, interns, temporary personnel, and technical SMEs; performs experiments when necessary.
• Guides junior USP team members by setting goals and tasks on projects.
• Adaptability required as work schedule may change based on business needs.

Requirements

• MSc with 8+ years of relevant work experience in Bioprocess Engineering, Life Science Biotechnology, Biochemistry, Protein Chemistry, Chemical Engineering, or related disciplines.
• PhD with 6+ years of relevant work experience in the same fields (desired).
• Process Development and Cell Line Development experience.
• Upstream Processing experience with Cell Culture, Bioreactor Technologies, and Transfection/Infection approaches.
• Prior work experience at a CDMO (desired).
• Criminal background check required.

Skills

• Hands-on experience with complex biologics, e.g., gene therapy, viral vaccines, therapeutic proteins.
• Experience with technology transfer and GMP manufacturing technical support.
• Experience with EMA/FDA regulations, ICH guidelines, GMP, and quality systems.
• Effective communicator with a track record of presenting data to relevant stakeholders, including external stakeholders.
• Experience with DoE design and statistical analysis on large data sets.
• Excellent scientific writing skills demonstrated by publications and reports.
• Experience with direct management of Scientists and Research Associates, including day-to-day oversight, direction, career development, and coaching.

Physical Demands

• Regularly sit for long periods of time.
• 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.
• Frequently lift and/or move up to 10 pounds; rarely lift and/or move up to 25 pounds.
• Frequently utilize close vision and the ability to adjust focus.
• Frequently required to communicate by talking, hearing, using telephone, and email.

Company Values

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

Benefits

• Paid vacation days, amount based on tenure.
• Paid sick time.
• 10 observed holidays + 2 floating holidays + 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.

About Genezen

Genezen provides process development, GMP viral vector production, and cell transduction for gene and cell therapy clinical trials. We are dedicated to empowering employees to be innovative, collaborative problem solvers in a fast-growing company. Every employee contributes to the success of the company.

Genezen operates in two locations: Fishers, Indiana, and Lexington, Massachusetts.

• Fishers, Indiana: A suburb of Indianapolis, named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety, and entrepreneurship. It is one of the fastest-growing communities in Indiana, dedicated to supporting a high quality of life for all residents. Nearby Indianapolis offers professional and college sports teams, the Indy 500, a growing art community, and the world’s largest children’s museum.
• Lexington, Massachusetts: Located just northwest of Boston, Lexington is renowned for its historic charm, tree-lined streets, and vibrant community. Known for its pivotal role in the American Revolution, Lexington offers a blend of historical landmarks, modern amenities, and a strong sense of community pride.