Johnson & Johnson Careers
Senior Scientist, Upstream Process Development
Spring House, Pennsylvania
Requisition ID: 4437190911
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Scientist, Upstream Process Development, located in 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.
The candidate for this position will direct and perform Late Stage process development activities for viral vector production processes within the API-Large Molecule group in Spring House, PA. The candidate’s primary responsibilities will include directing development activities in a cross-functional matrix team, including statistical design of experiments (DOEs), execution of the planned experiments and to determine appropriate ranges of (critical) process parameters. The candidate will write and review protocols, technical reports, regulatory documents and memos to summarize experiments and investigations. The candidate will explore future technologies and establish platforms/methodologies for efficient execution and delivery of upstream process characterization/process validation work packages. The candidate is expected to work effectively in a team environment as well as contributing individually to meet project timeline and objectives. Other duties will be assigned, as necessary.
• Lead/participate in all aspects of Late Stage Process Development activities of Janssen’s Cell Therapy portfolio that results in consolidation of CMC package to support BLA filing.
• Lead/accomplish full process characterization/validation (PC/PV) using strategy tools from QbD including execution of statistically designed experiments (DOEs), subsequent data analyses, identification of Critical Process Parameters (CPPs), Implementation of FMEA based risk assessment tools to justify/establish process parameter ranges (PARs).
• Knowledge and hands-on experience with mammalian cell culture, bioreactors, bioreactor process development, and bioreactor data analysis is required. Knowledge and hands-on experience with viral vector expression systems and process development is preferred.
• Familiarity with analytical methods typically used in the manufacture and characterization of viral vectors and cell therapy products is preferred.
• Ability to consolidate data from statistically designed experiments using software packages (JMP and Minitab), perform detailed analyses and develop suitable justification of process parameter ranges (PARs).
• Must have solid technical writing skills and is expected to author CMC sections of IND/BLA, technical reports, memos, protocols, SOPs, WIs, Master Plans and other Technical documents to summarize experiments and investigations.
• Lead discussions related to Validation Master Plans, Provide Technical oversight of Validation runs and author related Process Validation documents.
• Ability to work in a team environment and seamlessly coordinate activities across internal research and development teams, senior management, CRO/CDMOs, consultants, and regulatory experts.
• Build internal capabilities and establish a platform to perform Process Characterization/Validation efficiently for multiple projects.
• A PhD in Chemical Engineering/Biochemical Engineering with 3-4 years of relevant experience OR MS with at least 8-10 years of relevant experience OR a BS with at least 12 years of relevant experience is required.
• Experience with Cell Therapy and/or viral process development is preferred
• Deep familiarity with strategies and tools used in late-stage process development including: Phase 3 development, lock and scale up to commercial-scale; QbD tools of Risk Assessment, Process Characterization using single and multivariate DoE studies to define process design space; linking CPPs to Critical Quality Attributes(CQAs); key contributions to Validation Master Plan; and planning and oversight of PPQ runs for BLA submission is preferred.
• Strong familiarity with cGMPs and ICH guidelines is preferred
• Hands-on experience with the preparation of documents and regulatory sections supporting IND and BLA submissions is required
• Experience developing procedures and transferring of the processes to cGMP facility is required.
• This position is based in Spring House, PA and may require up to 20% 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.
United States-Pennsylvania-Spring House-
Janssen Research & Development, LLC (6084)