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Sr. Scientist - Upstream Process Development

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Genezen

Aug 26

  • Job
    Full-time
    Mid & Senior Level
  • Science
    Engineering
  • Lexington

AI generated summary

  • You need an MSc (8+ years) or PhD (4+ years) in a relevant field, process and cell line development experience, GMP knowledge, strong communication, and analytical skills, plus adaptability.
  • You will oversee upstream viral vector development, manage projects, lead scale-up activities, troubleshoot processes, analyze data, and guide junior team members while communicating with cross-functional teams.

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 4+ years of relevant work experience in Bioprocess Engineering/ Life Science Biotechnology/Biochemistry/ Protein Chemistry, Chemical Engineering or related disciplines
  • Process Development Experience
  • Cell Line Development Experience
  • Upstream Processing Experience with Cell Culture, Bioreactor Technologies, and Transfection/Infection approaches
  • 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
  • Experience with DoE design and statistical analysis on large data sets
  • Excellent scientific writing skills demonstrated by publications and reports
  • Fluent in English
  • Adaptability required as work schedule may change based on business needs
  • Criminal background check required

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. 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

FAQs

What are the main responsibilities of the Sr. Scientist - Upstream Process Development?

The main responsibilities include providing technical oversight for upstream viral vector drug substance development, leading platform improvement projects, managing late-stage development tasks, supporting technology transfer activities, providing manufacturing technical support, designing experimental plans, presenting data to stakeholders, and supervising activities in the USP labs.

What educational background is required for this position?

A Master's degree with 8+ years of relevant work experience or a PhD with 4+ years of relevant work experience in Bioprocess Engineering, Life Science Biotechnology, Biochemistry, Protein Chemistry, Chemical Engineering, or related disciplines is required.

Is experience with GMP manufacturing important for this role?

Yes, experience with technology transfer and GMP manufacturing technical support is desired and essential for the role.

What kind of work environment can I expect?

You will frequently work in a BSL 2 environment with necessary personal protective equipment and may occasionally be exposed to hazardous materials and machinery.

Are there opportunities for career development and growth at Genezen?

Yes, Genezen values innovation and collaboration, offering employees the opportunity to take on challenges and contribute to the success of the company, fostering a rewarding work environment.

What benefits does Genezen offer to its employees?

Genezen offers paid vacation days, sick time, holidays, a 401(k) plan with company match, healthcare plans, FSA and HSA programs, dental and vision care, employer-paid life insurance, and voluntary insurance options.

Is this a client-facing position?

Yes, the role involves regular interaction with clients and external presentations, making effective communication essential.

Are there any physical demands associated with this job?

Yes, the job requires frequent standing, lifting up to 25 pounds occasionally, and working in environments with large machinery and moving mechanical parts.

Does Genezen conduct background checks for this role?

Yes, a criminal background check is required as part of the hiring process.

Where are Genezen's locations?

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

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Genezen

Accelerating the Pace of Cell Therapy CMC and Clinical Development

Science & Healthcare
Industry
51-200
Employees
2014
Founded Year

Mission & Purpose

Genezen is a biotechnology company specialising in cell and gene therapy manufacturing. They focus on providing comprehensive services for the production of advanced therapies, including vector production and cell processing. Genezen’s approach combines expertise in cutting-edge technology with rigorous quality standards to support the development and delivery of innovative treatments. Their goal is to advance therapeutic solutions and facilitate the progress of gene and cell-based therapies through their state-of-the-art facilities and customised support.