Drug Product Tech Transfer Lead Role (Biologics)

pAt Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.com . /p pAs 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. /p h3Job Function: /h3 pSupply Chain Engineering /p h3Job Sub Function: /h3 pProcess Engineering /p h3Job Category: /h3 pScientific/Technology /p h3All Job Posting Locations: /h3 pBeerse, Antwerp, Belgium, Leiden, South Holland, Netherlands, Ringaskiddy, Cork, Ireland, Schaffhausen, Switzerland, Zug, Switzerland /p h3Job Description: /h3 pThe Technical Launch Integrator (TLI), posted as Drug Product Tech Transfer Lead, has overall accountability for ensuring fit for plant and commercial readiness during technical development, including implementation of new innovations technologies. The TLI is also responsible for the execution of the transfer of pharmaceutical processes and products into the supply chain and the global marketplace, as well as site-to-site transfers keeping the Best Process/Product at Launch (BPAL) mindset. Areas of key functions include DP technical support and oversight for supply chain, planning and execution of DP manufacturing site level support of new product launch. /p h3Objectives of the Position /h3 pTechnical and manufacturing integration of new and re-developed drug products from RD into the supply chain while using new innovations technologies keeping the Best Process/Product at Launch (BPAL) mindset. /p pContribution, review, and approval of drug product technical and regulatory documents, routine technical support, integration of supply chain technical expertise into project execution, and Quality by Design (QbD) technical implementation at the manufacturing site level. /p pSingle point of contact for supply plant readiness and execution and launch support between the Development and Commercial supply chain organizations. /p pIdentify and implement opportunities for active decrease of Cost of Goods (COGs) and partner with Development and supply chain groups to implement strategies to improve process robustness, fit for plant, and commercialization of new products into the supply chain. /p pDevelop the manufacturing site execution plan per product, in line with the overall strategy and plan as outlined by the relevant cross-functional teams; ensure alignment and endorsement of this strategy within the manufacturing site and TLI function. /p pCoordinate and implement product introduction at the site from transfer through launch covering raw materials, formula, process, packaging, and device integration into the finished product. /p pOptimize the New Product Introduction (NPI) process, make use of technology platforms, accelerate development timelines, and streamline the technical transfer process. /p h3What you will need to succeed /h3 pAbility to foster team efficiency and cohesiveness and to work collaboratively to implement, deliver and get results through the various matrix teams, and influence with or without direct authority. /p pMotivated, self-starter able to work independently with proven problem-solving skills. /p h3Qualifications: /h3 pMinimum of a Bachelor's or equivalent degree (required). M.S. or PhD /p pMinimum 6 years of relevant work experience with pharmaceutical product RD and/or Manufacturing / MSAT functions, or equivalent (required). /p pExperience with technical transfer of biopharmaceutical products into manufacturing sites, including technical knowledge of DP unit operations (required). /p pKnowledge of manufacturing site systems and procedures, including an understanding of GMP requirements (required). /p pKnowledge of DP late-stage development (preferred). /p pExperience with document management systems such as RIMdocs, TruVault, SAP, MS Office applications, Comet, and/or Planisware (preferred). /p pFPX, PMP, or equivalent Project Management certification (preferred). /p pProficient in English (required) language /p pUp to 20% domestic and international travel, depending on project needs (required) /p h3Preferred Skills: /h3 ul liAgile Decision Making /li liBusiness Savvy /li liCoaching /li liCorrective and Preventive Action (CAPA) /li liCrisis Management /li liCritical Thinking /li liDisruptive Innovations /li liEmerging Technologies /li liIndustrial Hygiene /li liLean Supply Chain Management /li liOrganizing /li liProcess Control /li liProcess Engineering /li liProduct Costing /li liProgram Management /li liProject Schedule /li liScience /li liTechnology /li liEngineering /li liand Math (STEM) Application /li liTechnical Research /li /ul #J-18808-Ljbffr