Johnson & Johnson is hiring a Principal Scientist, Downstream Processing & Purification located in Malvern, PA.
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The candidate for this position will lead and perform purification process development for the antibody-based modalities within the API-Large Molecule group in Malvern, PA. The candidate will lead the design and execution of development studies and use engineering principles to optimize the centrifugation, chromatography, and filtration process steps for product quality and productivity. You will identify and determine appropriate ranges of (critical) process parameters for the drug substance process and transfer technology to manufacturing partners. The candidate will write and review protocols, technical reports, regulatory documents, and memos to summarize experiments and investigations. The candidate will work effectively in a team environment, mentor individuals, as well as contribute individually. The candidate will work as a matrix leader managing a team achieving business objectives within project timelines. The candidate will learn and provide recommendations to refine existing downstream predictive models/simulations, create new mathematical models supporting development of current and novel therapies, and provide development and/or manufacturing troubleshooting, as needed.
Key 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.
Qualifications
Education:
- Minimum of a MS Degree in Chemical Engineering or Biological Sciences or Biochemistry and with at least 8 years of relevant experience or PhD with 2 years of relevant post-doctoral experience is required.
Experience and Skills:
Required:
- Knowledge and hands-on experience in downstream processing and purification of antibodies/recombinant protein therapeutics, in particular chromatography and filtration is required.
- Familiarity with analytical methods typically used in the manufacture and characterization of protein therapeutics is required.
- Process modeling supporting programs of varying stages of clinical development and process validation (experience using MATLAB, R, python, monte carlo, or other modeling and statistical software) is required.
- Knowledge of CMC, quality & compliance, regulatory requirements, and EHSS (Environment Health Safety and Sustainability) as relevant to large molecule pharmaceuticals is required.
- Demonstrate strong data-driven decision making and problem-solving capabilities
- Highly organized and capable of managing/pursuing multiple projects
- Good written and verbal communication skills
- Experience in maintaining written records of work in the form of laboratory notebooks (paper or electronic)
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.