Janssen Research & Development, LLC., a Johnson and Johnson Company is recruiting for a Senior Scientist, Microbiologist 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 www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
The Senior Scientist, Microbiologist within the DPD formulation/process team will have key responsibilities which include the impact of excipients and diluents on microbial growth in the development and clinical delivery stages of drug product development. They will design and execute experiments in support of formulation development of biologic drug candidates and study the molecular interactions of the drug product with excipients and materials (ancillaries, delivery systems, manufacturing equipment) associated with delivery to the patient; and how these components impact microbial growth/inhibition.
- Acts as subject matter expert for the scientific aspects in the microbial field and its impact to formulation, IV dosing and fill/finish processes of parenteral LM.
- Investigate the impact of buffers and excipients on microbial growth/inhibition on parenteral products in development.
- Design studies to determine the impact of microbial growth in a clinical IV design setting. Provides feedback to the formulation teams about technical performance and consistency with the design of Pharmacy Manual studies.
- Develop guidelines to prevent and correct deficiencies and improve the safety of drug product related development and manufacturing activities.
- Participates in criticality analysis, process FMEAs, process improvement initiatives, impact assessments and compliance gap analysis for parenteral products
- Contribute and influence the external environment as it relates to microbial challenge studies.
- Supports internal/external clinical and commercial organization or external contract manufacturers in troubleshooting for parenteral products requiring scientific expertise in the sterility space.
- Minimum requirements: BS/BA with 12 years’ experience, M.S. with 10 years’ experience or PhD with up to 3 years’ experience in the microbiology field with an emphasis in pharmaceutical development or pharmaceutical manufacturing or related post graduate academic experience/education.
Experience and Skills:
- In depth knowledge and proficiency in microbiological methods.
- Experience with microbiology/antibacterial methods and techniques used in the pharmaceutical industry, including micro challenge studies.
- Knowledge of both pharmaceutical product R&D and Technical Operations functions and experience with both small and large molecules.
- Experience working in a BSL2 environment would be useful
- Knowledge of CDC laboratory policies; and regulatory requirements
- Experience with introduction of pharmaceutical products to manufacturing sites and late state development with working technical knowledge of manufacturing site unit operations
- Demonstrated leadership in providing integration of activities and information across multifunctional groups and matrix teams
- Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix
- Work with stakeholders across the development and manufacturing organization.
- Ability to influence peers, superiors, and partners, internally and externally
This position is based in Malvern, PA.
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.
Janssen Research & Development, LLC (6084)