Sr/Principal Scientist - Upstream Process Development
Genezen
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Job summary
Genezen is seeking a Sr./Principal Scientist in Upstream Process Development to lead a team of scientists in our process development group. You will drive upstream development, characterization, technology transfer, and GMP manufacturing support, interfacing with Analytical, Manufacturing, Engineering, and MSAT to deliver robust scale-up strategies.
The role requires a PhD or MSc with extensive bioprocess experience, strong DoE and statistical skills, and excellent communication with clients and
Qualifications
- PhD with 6+ years relevant work experience in Bioprocess Engineering / Life Science.
- MSc with 8+ years relevant work experience in Bioprocess Engineering / Life Science.
- Experience with CDMO and cell line development is desirable.
Responsibilities
- Provides technical oversight for upstream viral vector drug substance development.
- Leads platform improvement and cross-functional project coordination.
- Manages late-stage development tasks and delivers protocol and reports.
- Supports technology transfer at pilot plant and scale-up efforts.
- Provides MSAT and manufacturing SME support for troubleshooting and deviations.
- Designs experimental plans and analyzes results; reviews ELNs and reports.
- Presents project progress to internal teams and clients.
Skills
Education
Tools
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.
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.
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.
- 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
- Adaptability required as work schedule may change based on business needs
- Criminal background check required
- Other duties as assigned
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
Process Development and Cell Line Development 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
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.
- 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 e-mail
ommitted to Science
rgency in action for the patients
esilience & Grit in operations
xecute with Excellence & Integrity
olutions driven for our partners
- 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
- 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.
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