Sr/Principal Scientist - Upstream Process Development

Genezen; Indianapolis (IN); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Paid vacation days

401(k) plan with company match

Choice of several healthcare plans

Employer-paid basic term life insurance

Job summary

Genezen is seeking a Sr/Principal Scientist for Upstream Process Development in Indianapolis, IN. This role involves managing a team and overseeing upstream process development, technology transfer, and GMP manufacturing support.

The ideal candidate will have an MSc or PhD with significant experience in bioprocessing and will lead cross-functional teams in a client-facing environment.

Qualifications

• MSc in Bioprocess Engineering or related discipline with 8+ years of relevant work experience.
• PhD in Bioprocess Engineering or related discipline with 6+ years of relevant work experience.
• Process Development and Cell Line Development Experience.

Responsibilities

• Provides oversight for upstream viral vector drug substance development activities.
• Leads continuous projects in USP labs.
• Supports manufacturing data analysis and troubleshooting.

Skills

Hands-on experience on complex biologics

Experience with technology transfer

Effective communicator

Experience with DoE design and statistical analysis

Education

MSc with 8+ years of experience

PhD with 6+ years of experience

Tools

Bioreactor Technologies

Statistical analysis software

Job description

Sr/Principal Scientist – Upstream Process Development

Indianapolis, IN

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.

JOB SUMMARY

The Sr./Principal Scientist, Upstream Process Development will be part of the Process Development Group reporting to the Director of Process Development. The role will have direct management responsibility for a team of Scientists and Research Associates. The Sr/Principal Scientist is responsible for the 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 within Genezen, including Analytical Development, Manufacturing, Engineering, and MSAT. This is a client‑facing position with regular interaction with our partners including external presentations, driving the technical discussion and program strategy.

JOB 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 in terms of protocol and report generation in areas such as scale‑down model qualification, process characterization, and scale‑down model process validation studies
• Leads and supports technology transfer activities at pilot plant and when necessary, performs experiments him/herself, focusing scale‑up platform process at scale and process improvements implementation, process characterization at scale and bills of materials as well as sampling plans
• Provides MSAT and manufacturing technical upstream SME support for process troubleshooting, manufacturing data analysis, root cause analysis, and deviations during GMP production, change controls, CAPAs, CCRs and other Quality Systems documentation as needed
• Designs and outlines experimental plans to meet the defined Genezen and client objective; analyzes and reviews experimental results and data
• Performs, optimizes, and maintains linear scale‑down models; writes, reviews, and approves electronic lab notebook (ELN) 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 that have an impact on or are impacted by upstream process development
• Coordinates and supervises the activities in the USP labs (with a team of engineers/ (Jr.) bioprocess technologist, co‑op students, interns, temporary personnel (contractors), and technical SMEs) and when necessary, performs experiments him/herself. Guides junior USP team members by setting goals/tasks on projects

SPECIAL JOB REQUIREMENTS

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

EDUCATION / CERTIFICATIONS / LICENSES

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 Bioprocess Engineering / Life Science Biotechnology / Biochemistry / Protein Chemistry, Chemical Engineering or related disciplines

ON‑THE‑JOB EXPERIENCE

• 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

SKILLS / ABILITIES

• Hands‑on experience on 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 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 and direction and career development and coaching

PHYSICAL DEMANDS

Regularly sit for long periods of time.

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
• Rarely 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
• 401(k) plan with company match up to 6% of salary, vested immediately
• Choice of several healthcare plans
• FSA and HSA programs
• Employer‑paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident 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.