MSAT Drug Product External Principal 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 jnj.comAs guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.Job Function: Supply Chain EngineeringJob Sub Function: Process EngineeringJob Category:Scientific/TechnologyAll Job Posting Locations:Guaynabo, Puerto Rico, United States of America, Titusville, New Jersey, United States of AmericaJob Description:About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow!Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.Learn more at We are searching for the best talent for a MSAT Synthetics Drug Product External Principal 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 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 Synthetics DP External Site Pr. Scientist is responsible for providing technical oversight to external manufacturing (EM) sites. They shall also lead all aspects of 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 validationSupport NPI using applicable tools and standards in collaboration with Virtual Management Team (VMT), key supply chain functions, Technical launch integrators / owners, and EM siteAct as Technical coordinator for CMO process technology proficiency assessment, technology standards, and implementation of MSAT Technology RoadmapsServe 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 / actionsMaintain and develop good understanding of the status regarding ongoing and future planned technical activities at siteEngage 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- licensingSupport 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/adherenceConduct technical assessment of change controls and other quality related activities by associating with Quality for audits and inspectionsProvide technical support on site for investigations and resolution of deviation / OOS (process, cleaning, troubleshooting) by collaborating with engineering, product launch, and technical ownersQualifications: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 preferredExperience and Skills:Required:Minimum 6 years of relevant work experienceDemonstrated experience/expertise with various dosage forms, including experience with solids manufacturing technology, process, and transferExperience 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/sectorAbility to lead activities under general direction, and demonstrate a good sense of prioritization of assigned tasks & goals and handle time accordinglyStrong understanding and knowledge of Q&C (Quality & Compliance) and the regulatory requirements (e.g., GMP, EHSS, etc.) related to pharmaceutical manufacturing environmentPreferred:Experience in new pharmaceutical manufacturing technology especially OROS technology, continuous manufacturing, or related technologyUnderstanding and application knowledge in statistics and process excellence / investigation toolsOther:May require up to 25% travel, domestic and/or international depending on business needsFor more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.Required Skills:Preferred Skills:Agile Decision Making, Business Savvy, Coaching, Corrective and Preventive Action (CAPA), Crisis Management, Critical Thinking, Disruptive Innovations, Emerging Technologies, Industrial Hygiene, Lean Supply Chain Management, Organizing, Process Control, Process Engineering, Product Costing, Program Management, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Technical ResearchThe anticipated base pay range for this position is :102,000-173,400Additional Description for Pay Transparency:Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. Titusville, New Jersey, United States of America; Guaynabo, Puerto Rico, United States of AmericaType: Full time