MSAT (manufacturing science & technology) Senior Scientist / Engineer, Drug Product

Jobbeschreibung

Schaffhausen, Schaffhausen, Schweiz
Johnson & Johnson
27.04.2024
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DescriptionPosition SummaryThe Drug Product Technical Owner (DP TO) is the voice of TO in the Value Chain Team and responsible for the technical aspect of the holistic Lifecycle Management structure and strategy of API & drug product (for Small Molecule Parenterals, Large Molecules and both for new and legacy products)ResponsibilitiesAs part of the VCM team:represents MTO / TO and the technical team in the Value Chain Team (VCT), owns the coordination of all API and product-related technical activitiesparticipates in development of long-term supply strategy including scenario development and E2E impact analysisparticipates in technical, quality and compliance risk assessment and development of mitigation strategies and possible BCP optionscollaborates with R&D, site functions and finance to identify COGS improvement opportunities (COGS optimization process)supports the value chain team to identify improvement/innovation opportunities, to build project business cases and to prioritize projects (product related)monitors technical process and product performancesupports failure investigations (escalation of quality or compliance eventsexecutes or follows-up on execution of technical projectsensures smooth transfer from TLI to DPTO preferably prior to SG 12 (but aligned with transfer of ownership from launch and grow VCM to LCM VCM)supports inspection readinessAs the lead/participant of the Technical Team:understands the technical aspect of the lifecycle strategy of productsapplies the science-based risk approach and regulatory intelligencemanages a multi-disciplinary team of technical experts in the following areas: mfg. site representative, DS and DPDevelopment & Material Sciences, stability department, regulatory department, and Q&Ccreates, maintains, and upgrades product technical knowledge and supports the info as an element of the overall value chain knowledge infrastructuremonitors technical process and product performance across internal and external mfg. sitesperforms internal and external benchmarking activitiesdeploys the platform standardization policy as appropriatreviews technical product & process risk profile and criticality analysislooks for technical improvement and innovation opportunitiescoordinates with mfg. sites and process engineering the implementation of new process technologies (where appropriate)identifies and resolves issues, anticipating to potential future issuesparticipates in EHS management teamsQualificationsFunctional expertiseStrong expertise with regards to pharmaceutical products & manufacturing processesGood knowledge of Q&C / regulatory requirements / GMP / EHSInterpersonal skills and attitudeAbility to lead cross functional / cross-region project teamAbility to manage complexity and changeAbility to interact at different levels of the organization (including Sr. Management)Ability to work under pressure and resolve conflictsAbility to work independently under general direction, having a good sense of prioritization of assigned tasks and manage time accordingly.Ability to create or be part of a result-oriented project teamDrives for innovation and change to ensure competitivenessCan-do mentality, agility & flexibility able to work with stretched goals and deadlinesSets targets for a team first and work with others towards these goalsUnderstands culture differencesCommunicates, motivates, negotiates and is an assertive person having impactShows a high sense of responsibility regarding professional activitiesLanguagesFluent in written and spoken EnglishPhysical requirements:Works in an international environment across different time zones Frequent travel requiredTravel: Min 10% - project dependent#LI-MV2Job Field: Process EngineeringOrganization: Cilag AG (8562)