MSAT SM DP External Senior Scientist

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 Senior Scientist will provide Technical oversight to external manufacturing 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 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 and influence decisions of Site Lifecycle processes (Due diligence / Selection, Onboarding, Engage, Ongoing Monitoring, Disengage) including support to localization; also 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

Qualifications

Education:

• Minimum of a Bachelor's/University or equivalent degree required; Master's or PhD and/or focused degree specialization in Engineering, Pharmaceutical Science, or equivalent technical subject is preferred

Experience and Skills:

Required:

• Minimum 8 years of relevant work experience

• Demonstrated experience/expertise with various dosage forms, including experience with solids manufacturing technology, process, and transfer

• Experience working with external manufacturing network (CMO)

• Basic knowledge of Small Molecule Supply chain (products, customers, suppliers, plants)

• Strong communication and collaboration/networking skills with the ability to interact at different levels of the organization/sector

• Ability to lead activities under general direction, and demonstrate a good sense of prioritization of assigned tasks & goals and handle time accordingly

• Strong understanding and knowledge of Q&C (Quality & Compliance) and the regulatory requirements (e.g., GMP, EHSS, etc.) related to pharmaceutical manufacturing environment

Preferred:

• Experience in new pharmaceutical manufacturing technology especially OROS technology, continuous manufacturing, or related technology

• Understanding and application knowledge in statistics and process excellence / investigation tools

Other:

• May require up to 25% travel, domestic and/or international depending on business needs

• Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week and depending on business needs

Why join Johnson & Johnson

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