Senior Process Development Scientist

1 month ago

Indianapolis, Indiana, United States Genezen Full time
Job Summary

Genezen is seeking a highly skilled and experienced process development scientist to lead the development and establishment of processes in our Process Development department. As a key member of our team, you will be responsible for developing a scalable platform for viral vector production processes that minimizes the risk during process development to GMP scale-up.

Key Responsibilities
  • Develop and implement process development strategies to ensure efficient and effective process development and scale-up.
  • Collaborate with cross-functional teams to design and execute experiments, analyze data, and communicate results to senior management and team members.
  • Monitor and report on process performance, identify opportunities for improvement, and implement changes to enhance process, product safety, and product quality.
  • Design and execute experiments to optimize process conditions, including upstream and downstream processing, and develop and support process optimization efforts to increase process robustness, reduce costs, and improve viral yield and purity.
  • Maintain open communication with team members, stakeholders, and senior management through regular meetings and updates.
  • Stay current with relevant technologies and industry developments, and identify new approaches to improve process development and scale-up.
  • Perform and lead single-use system design, selection, implementation, and configuration in between upstream bioreactor and downstream unit operations and control strategies.
  • Develop and maintain proper SOPs for downstream processes.
  • Responsible for process transfer from or to clients and to in-house manufacturing plant.
  • Maintain external technical relationships and collaborate with equipment and material suppliers.
  • Serve as process SME for regulatory and client audits.
  • Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the assigned functional area.
Requirements
  • BS, MS, or PhD in biological engineering or related field.
  • 5-8 years of relevant industry experience in process development, scale-up, and GMP manufacturing.
  • Solid foundation in the fundamentals of biochemical engineering, virology, and cell biology.
  • Entrepreneurial experience dealing with customers in product development.
  • Pharmaceutical industry experience in technical support of cGMP manufacturing and/or process development, including experience with Contract Development and Manufacturing Organizations.
  • Experience with cell culture technologies, molecular biology, upstream processing, and aseptic processing.
  • Solid knowledge of principles of chromatography with AKTA system and Unicorn software and TFF.
  • Solid knowledge of principles of aseptic technique.
  • Working knowledge of cGMPs related to the production of viral therapeutics.
  • Ability to interface successfully with multi-disciplined teams.
  • Extremely detail-oriented with strong technical skills and mechanically inclined/knowledge of hand tools.
Benefits
  • Paid vacation days, amount based on tenure.
  • Paid sick time.
  • 9 observed holidays + 1 floating holiday + 1 volunteer day.
  • 401(k) plan with company match up to 6% of salary, vested immediately.
  • 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
  • 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.

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