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Scientist, Molecule Drug Product Development

Job in PA Pennsylvania - USA
Company: Johnson & Johnson
Full Time position
Listed on 2021-07-23
Job specializations:
  • Science
    Biochemistry, Chemistry, Science Research
  • Pharmaceutical
    Pharmaceutical Product Manager
Job Description & How to Apply Below
Location: Malvern

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Scientist, Large Molecule Drug Product Development to be located in Malvern, PA or Spring House, PA.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.

We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at  @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

The Scientist in the Large Molecule (LM) Drug Product Development (DPD) will work independently and in conjunction with appropriate teams to define scientific strategy and to support program/project needs. The candidate will also independently lead, design and perform development and characterization in support of formulation, process, and fill-finish activities for large molecules (e.g. mAbs, fusion proteins, bi-specifics, etc). This role requires candidate can provide matrix leadership and support people development.

Key Responsibilities:

  • Design, execute, and lead formulation and process development experiments for monoclonal antibodies and other protein candidates. Studies include, but not limited to, formulation development, process development, stability, robustness, and the development of fill/finish processes.
  • Lead, facilitate, and participate in technical discussions to successfully resolve problems with suppliers, methods, project issues and deviations.
  • Author and review documents for regulatory filings (IND, IMPD, BLA, MAA) and internal company use. Design experiments and provide relevant data to support responses for regulatory agencies minor deficiency letters.
  • Create an environment of scientific excellence and advancement, including knowledge of current landscape, external engagement, and industry direction.


  • Qualifications

  • BS in Engineering (Biomedical, Bioengineering, Chemical, or Mechanical) with 7 years experience, or MS with 5 years of work experience, OR PhD with 1-2 years of work experience is required
  • Proven proficiency and experience in biologics (mAbs, proteins, gene therapies, cell therapies etc) with a high level of technical understanding is required
  • Demonstrated record of scientific publications is required.
  • Effective communication skills and demonstrated leadership in providing integration of activities and delivering information across multifunctional groups and sites is preferred
  • The candidate should be able to use emerging developments in relevant scientific fields to generate new research ideas and initiatives. Association with scientific organizations and external engagement/influence is preferred.
  • Experience with authoring and reviewing regulatory filings (IND, IMPD, BLA, MAA) is preferred.
  • This position will be based in Malvern/ Spring House and may require up to 10% international and domestic travel.
  • 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.


     
     
     
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