Senior Associate Scientist, Large Molecule Drug Product Development
Posted on Apr 5, 2021 by Johnson & Johnson
Janssen Research & Development, L.L.C., a division of Johnson & Johnsons Family of Companies is recruiting for a Sr. Associate Scientist, Large Molecule Drug Product Development to be located in Malvern, 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 Senior Associate Scientist will be a member of the formulation development team within the Drug Product Development (DPD) - BioTherapeutics (BioTD) department. The Sr. Associate Scientist will be involved with DPD activities related to laboratory execution of formulation research and development, process improvements, and fill/finish activities for large molecules (eg mAbs, fusion proteins, bi-specifics, etc). Within the DPD team you will have accountability for designing, executing, and analyzing formulation development studies to support early and late stage programs. The ability to communicate across diverse teams is required for success in this role.
Execute and analyze formulation development experiments for monoclonal antibodies and other biologic drug candidates (including vaccines, gene therapy, ADC), including characterization studies relevant to the stage of development. Studies include, but are not limited to, biophysical characterization, stability, composition selection and robustness and development of administration protocols.
Author and review documents for regulatory filings (IND, IMPD, BLA, MAA) and internal company use. Execute experiments and provide relevant data to support responses for regulatory agencies minor deficiency letters.
Support the issuance of regulatory submission documents.
B.S. degree in Chemical, Mechanical, Electrical, Biomedical Engineering or other related field with 2-4 years of related work experience is required OR M.S. degree with 1-3 years experience, Pharmaceutical Development or Pharmaceutical Manufacturing experience is preferred.
Experience with large molecules (monoclonals, cell therapies/cultures, proteins, virus like modalities) is preferred.
Basic knowledge of both pharmaceutical product R&D and Technical Operations functions is preferred.
Organizational skills capable of effective execution of Drug Product (DP) formulation studies and analysis
Prior laboratory experience in academia or industry is required.
Experience in data analysis, design of experiments, and statistical analysis is preferred
Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various Matrix teams is desired.
This position is located in Malvern, PA and may require a minimum of 10% travel (project dependent).
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.