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Principal Scientist, MSAT Synthetics Liquid DP
Johnson & JohnsonPrincipal Scientist at Johnson & Johnson overseeing technical aspects of external manufacturing in MSAT Division. Focus on drug product technology transfer and quality compliance across locations.
Tech Stack
Tools & technologiesSwitching
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- 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
- 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.
Benefits
Comp & perks- 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.
- 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.
- service anniversary and recognition awards
- subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Dosage Form ExpertiseLiquid & Solids Manufacturing TechnologyGMP KnowledgeStatistical AnalysisProcess Excellence Tools
Soft Skills
Strong Communication SkillsTeamwork & Networking AbilitiesLeadership Under General DirectionPrioritization & Time Management