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Scientist, Large Molecule Drug Product Development

Posted on Apr 6, 2021 by Johnson & Johnson

Gwynedd, PA 19436
Retail Trade
Immediate Start
Annual Salary
Full-Time


Job Description


Janssen Research & Development, L.L.C., a division of Johnson & Johnsons Family of Companies is recruiting for a Scientist, Large Molecule Drug Product Development, 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 and follow Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.


The Scientist in Large Molecule (LM) Drug Product Development (DPD) will work independently and in conjunction with appropriate teams to support program/project needs. The candidate will also independently lead, design and perform development and engineering in support of process and fill-finish activities for large molecules (eg monoclonal antibodies, fusion proteins, bi-specifics, gene therapies, cell therapies etc).


Key Responsibilities:


Lead biologics drug engineering and design studies relevant to the stage of development. Studies include, but not limited to, equipment design, process characterization, stability, robustness, and the development of fill/finish processes.


Lead process development studies to determine and characterize process parameters associated with preparation of biologic drug products. Studies include, but are not limited to, freeze-thaw, mixing, filtration, pumping, filling, biophysical characterization, stability, composition robustness, lyophilization, spray drying, spray-freeze drying.


Lead, facilitate, and participate in technical discussions to successfully resolve problems with suppliers, methods, project issues and deviations.


Supervise, guide, and mentor junior scientists within the manufacturing sciences.


Lead the overall strategic design, development and deployment of engineering activities to ensure competitiveness and organizational excellence.


Deliver an improved focus on the engineering concepts, ensuring consistent scientific excellence and scientific quality standards are met.


Qualifications


Bachelor's degree, (in Engineering Biomedical, Bioengineering, Chemical, Electrical or Mechanical or related) with 7 or more years of experience is required


OR


Master's degree with 5 or more years of work experience is required


OR


PhD with 1 or more years of work experience is required


Formulation Development experience is a preferred.


Proven proficiency and experience in biologics and device development (ie. mAbs, gene therapies, cell therapies etc) within the pharmaceutical industry with a high level of technical understanding is required


Lean & Six Sigma certification and proven experience in business transformation is preferred


Experience with multiple aspects of drug development, including technical, regulatory, and project management is required.


Effective communication skills and demonstrated leadership in providing integration of activities and delivering information across multifunctional groups and sites is preferred


Detailed knowledge of design controls for drug development, engineering and process controls equipment installation is preferred


This position will be based in Malvern, PA (preferred) or Spring House, PA and may require up to 15% 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.




Reference: 1152695952

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