MSAT SM DP External Scientist
Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an MSAT Small Molecule Drug Product (SM DP) External Scientist!
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Are you interested in joining a global and diverse team that is helping improve patient care and drive innovation? Apply today for this exciting opportunity!
MSAT (Manufacturing Science and Technology) is a division of the Innovative Medicine Supply Chain (IMSC) of Johnson & Johnson. MSAT is a worldwide organization with members located across the geography in close vicinity to the Internal Manufacturing Network (MTO) and External Manufacturers, providing Technical Competence and Manufacturing Excellence to Johnson and Johnson’s pharmaceutical environment and product portfolio.
The MSAT SM DP External Scientist is responsible for providing technical oversight to external manufacturing (EM) sites. They will also be responsible for site ownership in performing due diligence, auditing, and site onboarding. The Scientist will conduct technical/risk assessment, execution, and/or oversight of New Product Introduction (NPI), technical transfers, and Product Life Cycle (LCM) management. They will be involved with standards and new technology deployment, Multi-Variate Analysis (MVA) & statistical analysis, Proactive assessments and de-risking of products and process through collaboration with various other MSAT teams, different functions, and partners.
Key Responsibilities:
- Handle execution of drug product technology transfer, product life cycle activities, material qualification, and cleaning validation
- Support NPI using applicable tools and standards in collaboration with Virtual Management Team (VMT), key supply chain functions, Technical launch integrators / owners, and EM site
- Act as Technical coordinator for CMO process technology proficiency assessment, technology standards, and implementation of MSAT Technology Roadmaps
- Serve as primary contact and site owner for technical issues related to EM and represent in VMT by being a single technical voice including EM, thus supporting decision / actions
- Maintain and develop good understanding of the status regarding ongoing and future planned technical activities at site
- Engage in Site Lifecycle processes (due diligence / selection, onboarding, engage, ongoing monitoring, disengage) including support to localization; also be involved in technical assessment / due diligence of product portfolio / in- licensing
- Support working models and tools in handling EM from technical perspective which includes Technical risk metrics & Switching Effort / Complexity metric for fit-for-purpose segmentation model, and account planning/adherence
- Conduct technical assessment of change controls and other quality related activities by associating with Quality for audits and inspections
- Provide technical support on site for investigations and resolution of deviation / OOS (process, cleaning, troubleshooting) by collaborating with engineering, product launch, and technical owners
