MSAT Synthetics Liquid DP External site Principal Scientist

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Johnson & Johnson Inc. is recruiting for an MSAT Synthetics Drug Product External site Pr. Scientist

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 Johnsons pharmaceutical environment and product portfolio.

The MSAT Synthetics DP External Site Pr. 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.

• 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

• Minimum of a Bachelors/University or equivalent degree required; Masters or PhD and/or focused degree specialization in Engineering Pharmaceutical Science or equivalent technical subject is preferred

Required:

• Minimum 8 years of relevant work experience
• Demonstrated experience/expertise with various dosage forms including experience in process science and tech transfer of Liquid & solids manufacturing technology.
• Experience working with external manufacturing network (EM)
• Basic knowledge of Small Molecule Supply chain (products customers suppliers plants)
• Strong communication and teamwork/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 specialized technology which includes Freeze dried tablets Softgel capsules etc. new pharmaceutical manufacturing technology especially 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

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The anticipated pay range for this position in the primary posting location is:

The anticipated pay ranges for additional locations are:

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.