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Scientist, Life Cycle Management, Large Molecule Material Science

Malvern, Pennsylvania; Spring House, Pennsylvania
R&D


Job Description

Requisition ID: 9046190703

Janssen Research & Development, LLC ., a division of Johnson & Johnson's Family of Companies is recruiting for a Scientist, Life Cycle Management, Large Molecule Material Science 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 www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Material Science is a department within Pharmaceutical Development and Manufacturing Sciences- Large Molecule Value Stream (PDMS-LM VS). In this role you will support life cycle management of raw materials used in the clinical and commercial supply chain including Bill of Materials Assessment and other activities supporting raw material readiness as part of tech transfer to both internal and external manufacturing sites.

Responsibilities:
• Partner with Janssen Development teams and Janssen internal and external manufacturing sites/partners to guide the selection of materials based on scientific, quality and regulatory criteria
• Develop strategy for and either directly generate or participate in generation of:
o Raw material testing & release specifications and supporting documents for materials including but not limited to cell culture media, chromatography resins, excipients, adjuvants, and disposables
o Risk assessments for raw materials with Janssen internal and external manufacturing sites/partners & suppliers
o Raw material Qualification strategy in close collaboration with partners in Material Science, Technical Operations, Quality, Procurement, Planning and DPDS.
o Effective raw materials control strategies based on understanding and importance of raw material critical attributes and use Janssen internal and external manufacturing
• Execute on new raw material introduction & qualification with:
o Support for supplier audits/selection as required
o Formulation of raw material testing & characterization plans in close collaboration with Material Science colleagues, APILM, and Drug Product technical teams, to advance understanding of raw materials in manufacturing processes and formulations
• Support for Regulatory Filing & Inspections, ensuring compliance with safety, GMP, quality and scientific principles for raw materials used by Janssen internal and external manufacturing sites/partners
• Lifecycle Management activities including:
o Management of supplier-initiated and CMO-initiated changes
o Review and implement industry and regulatory requirements for raw materials, e.g., ICH guidance
o Support for raw material investigations including leading and/or participating in root cause analyses
• Actively participate on cross-functional R&D and manufacturing teams to advance projects goals and deliverables related to raw materials
• Participate in project and scientific meetings to share information, knowledge, ideas, and judgment to help establish valid scientific directions in product development or investigations

Additional position responsibilities:
• Leading and actively participating in cross-functional matrix teams to support raw material tech transfer and new material introduction and qualification
• Compile raw material information from various sources (suppliers, CMOs, internal sites and function, regulatory/industry, compendia) and organize for broader use within LM Material Science team for assessment of raw material suitability for clinical and commercial supplies
• Technical writing for raw material technical reports including compilation and analysis of supplier-provided data (e.g., stability data), specifications, justification of specifications, and technical memos
• Change Control management supporting above (Trackwise)
• Executing with a mindset for continuous improvement and process improvement


Qualifications
• A Bachelor’s Degree in Chemistry, Biology, Materials Science and Engineering, Biochemical Engineering, Chemical Engineering, Pharmacy/Pharmaceutics with 9-10 years of industrial experience or a Master’s Degree with 6-8 years of experience.
• Demonstrated leadership in providing technical and scientific integration of activities and delivering information across multifunctional groups and sites including external suppliers and CMOs is required
• Demonstrated competency in effective written and verbal communication and good documentation practices are required
• Demonstrated competency and experience in development and management of raw materials specifications including compendia testing is preferred
• Demonstrated scientific contributions to the selection, use and qualification of raw materials for biological products – notably cell culture media, excipients and adjuvants - are preferred
• Demonstrated competency and experience in product development within the pharmaceutical industry is preferred
• Demonstrated competency and experience in use of project management tools (e.g., MS Project), spreadsheet and databases are strongly preferred
• Demonstrated experience is lean and/or six sigma methodologies and tools is preferred
• This role is based in Malvern, PA or Spring House, PA and may require up to 10% of domestic and international 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.



Primary Location
United States-Pennsylvania-Malvern-
Other Locations
North America-United States-Pennsylvania-Spring House
Organization
Janssen Research & Development, LLC. (6084)
Job Function
R&D
Requisition ID
9046190703