Description

Janssen Research & Development, L.L.C., a division of Johnson & Johnson’s Family of Companies is recruiting for a Senior Scientist, located in Spring House, PA or 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 www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies. 

The Senior Scientist in the Large Molecule Drug Product Development will be a lab-based role, responsible for experimental studies in pre-formulation, formulation, characterization and analytical development of cell and gene therapies including CAR-T and viral vector modalities for early, mid, and late-stage new molecular entity (NMEs). This includes development and optimization of the technical operations associated with aseptic technique, formulation and fill/finish, cryopreservation and diluent compatibility/administration relevant studies. In addition, biophysical/analytical method development and data interpretation to analyze different biologics modalities is required. 

Key Responsibilities:

• Develop and optimize drug product formulations.
• Complete characterization plans and stability studies with the goal of developing a better understanding of stabilization mechanisms.
• Lead or participate in cross-functional teams at project-related meetings, lead or facilitate technical discussions, and successfully resolve problems with supplies, methods, project issues, and deviations.
• Perform technical analysis of the project data, including trending of data.
• Author technical reports and regulatory filings, present data to peers and functional management.
• Collaborate with functional line management as well as scientists in related functional areas such as Research and Development, QC/QA, Clinical, Manufacturing, Toxicology, and Regulatory (CMC).
• Design and complete studies relating to formulation and filling unit operations including mixing, vial, bag, and syringe filling, cryopreservation, and overseeing the execution of development, small scale to GMP grade fill/finish manufacturing processes.
• Plan and implement compatibility studies to support administration of large molecules.
• Design and manage stability studies on target and experimental formulations.
• Perform duties consistent with good laboratory practices.

Qualifications

Education:

• PhD with 3+ years of experience, M.S. degree with 8+ years of experience, or B.S. degree with 10+ years of experience in an appropriate scientific field (Life Sciences or Chemical Engineering) is required.

Experience and Skills:

Required:

• Solid understanding of flow cytometry is required.
• Mammalian cell culture experience is required.
• Ability to interpret and analyze data from biophysical assays and craft appropriate experiments is required.
• Strong written and verbal communication skills are required.

Preferred:

• Experience in CAR-T production/culture is preferred.
• Mammalian cell cryopreservation/cryobiology experience is preferred.
• Characterization of T cell subpopulations experience and an understanding of immunology is preferred.
• Experience implementing and maintaining high quality standards for all aspects of work conducted including adherence to regulatory GLP/GMP, departmental, and safety guidelines is preferred.
• Experience mentoring others in a matrix environment is preferred.

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.