Sr/Principal Scientist - Upstream Process Development

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, preforms 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. Analyses 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 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

Knowledge, Skills and Experience

EDUCATION / CERTIFICATIONS / LICENSES - Essential/Desired

MSc with 8+ years of relevant work experience in Bioprocess Engineering/ Life Science Biotechnology/Biochemistry/ Protein Chemistry, Chemical Engineering or related disciplines - Essential

PhD with 6+ years of relevant work experience in Bioprocess Engineering/ Life Science Biotechnology/Biochemistry/ Protein Chemistry, Chemical Engineering or related disciplines - Desired

ON-THE-JOB EXPERIENCE

Process Development and Cell Line Development Experience - Essential

Upstream Processing Experience with Cell Culture, Bioreactor Technologies, and Transfection/Infection approaches - Essential

Prior work experience at a CDMO - Desired

SKILLS / ABILITIES

Hands-on experience on complex biologics, e.g. gene therapy, viral vaccines, therapeutic proteins - Essential

Experience with technology transfer and GMP manufacturing technical support - Essential

Experience with EMA/FDA regulations, ICH guidelines, GMP and quality systems - Essential

Effective communicator with track record of presenting data to relevant stakeholders including external stakeholders - Essential

Experience with DoE design and statistical analysis on large data sets - Essential

Excellent scientific writing skills demonstrated by publications and reports - Essential

Experience with direct management of Scientists and Research Associates including day-to-day oversight and direction and career development and coaching. - Essential

Physical Demands

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• 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 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
• 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.