Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies is recruiting for a Scientist/Pharmacist, 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.

The successful candidate will work in the Biotherapeutics Drug Product Development (DPD)department. The candidate will help develop, design and perform formulation development and characterization in support of formulation and clinical dose preparation and administration of vaccines, mAb and other biological drug products.

Major Duties and Responsibilities to Include:

• Formulation Development
  • Design and execute formulation development experiments for biologic drug candidates (including vaccines and monoclonal antibodies), including rational formulation design/selection plus 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.
  • Prepare 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.
  • Lead or participate in cross-functional teams at project-related meetings, lead or facilitate technical discussions and successfully resolve problems with suppliers, methods, project issues and deviations.
• Clinical Interface
  • Design and execute studies to understand how the drug product interacts with the product contact material surfaces during fill/finish manufacturing and during dosage preparation and delivery of oncolytic viruses and other biologic drug products.
  • Collaborate with DPD Formulation Scientists, Global Trial Mangers, Clinical Physicians, Study Managers and Pharmacists to ensure that the drug product preparation and administration can be flawlessly executed at clinical sites for Phase 1 to Phase 3 clinical studies
  • Participate in cross functional meetings with clinical scientists, pharmacists, nurses and physicians to ensure harmonization of drug delivery to the patients.
  • Assist in review of phase 1-3 clinical protocols.
  • Investigate dose preparation and/or delivery issues at clinical site collaborating with internal clinical and quality teams.

QUALIFICATIONS

• PharmD with 0-3 years experience in hospital or community pharmacy, or industry experience in Pharmaceutical, Biopharmaceutical, Chemical or related industry. Ph.D. in pharmaceutical sciences or related field with 0-3 years industry experience in Pharmaceutical, Biopharmaceutical, Chemical or related industry. M.S. in pharmaceutical sciences or related field with 5-7 years industry experience in Pharmaceutical, Biopharmaceutical, Chemical or related industry is required.
• Clinical experience in hospital or community pharmacy is required.
• A strong understanding on drug compounding and delivery is required.
• Familiarity with Good Clinical Practices and Good Pharmacy Practices is required.
• Familiarity with USP 797 and USP 800 is required.
• Knowledge and experience of biopharmaceutical formulation and process design is preferred.
• An understanding and experience in the application of various GXP and QbD concepts is preferred.
• The ability to develop, document and analyze experiments that significantly contribute to process and material knowledge, including discerning and communicating testing outcomes effectively with cross-functional teams is required.
• Technical writing skills, including the ability to maintain high quality documentation and prepare reports, SOPs or other technical reports is required.
• Sound protein analytical knowledge and experience with a variety of standard protein analytical methods (e.g. HPLC, and particle methods) and biophysical techniques is preferred.
• This role is located in Malvern, PA and may require 10% of 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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