Johnson & Johnson - Malvern, PA

posted 2 months ago

Full-time - Senior
Malvern, PA
Chemical Manufacturing

About the position

The Principal Scientist, Downstream Processing & Purification at Johnson & Johnson will lead the purification process development for antibody-based modalities within the API-Large Molecule group. This role involves designing and executing development studies, optimizing engineering processes, and transferring technology to manufacturing partners. The candidate will also be responsible for writing and reviewing technical documents and mentoring team members, contributing to both individual and team objectives.

Responsibilities

  • Lead and perform purification process development for antibody-based modalities within the API-Large Molecule group.
  • Design and execute development studies to enhance purification processes.
  • Utilize engineering principles to optimize centrifugation, chromatography, and filtration process steps for improved product quality and productivity.
  • Identify and establish appropriate ranges for critical process parameters in drug substance processes.
  • Transfer technology and knowledge to manufacturing partners to ensure smooth implementation of processes.
  • Write and review protocols, technical reports, regulatory documents, and memos to document experiments and investigations.
  • Collaborate effectively within a team environment while also contributing individually to project goals.
  • Coach and mentor team members to enhance their skills and contributions to the team.
  • Analyze and refine existing downstream process models to improve efficiency and effectiveness.
  • Develop new predictive models to facilitate process development and technology transfer of current and novel therapies (including scale-up and scale-down models).
  • Provide troubleshooting support for development and manufacturing processes as needed.

Requirements

  • Minimum of a MS Degree in Chemical Engineering or Biological Sciences or Biochemistry with at least 8 years of relevant experience or PhD with 2 years of relevant post-doctoral experience.
  • Knowledge and hands-on experience in downstream processing and purification of antibodies/recombinant protein therapeutics, particularly chromatography and filtration.
  • Familiarity with analytical methods used in the manufacture and characterization of protein therapeutics.
  • Experience with process modeling supporting programs of varying stages of clinical development and process validation, using MATLAB, R, Python, Monte Carlo, or other modeling and statistical software.
  • Knowledge of CMC, quality & compliance, regulatory requirements, and EHSS as relevant to large molecule pharmaceuticals.
  • Demonstrate strong data-driven decision making and problem-solving capabilities.
  • Highly organized and capable of managing multiple projects.
  • Good written and verbal communication skills.
  • Experience in maintaining written records of work in the form of laboratory notebooks.
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