MSAT SM DP PARENTERALS, SCIENTIST TLI

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 https://www.
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Introduction and Overview Manufacturing Science and Technology (MSAT), being part of the Innovative Medicine Supply Chain (IMSC) and, a member of the Johnson & Johnson Family of Companies, is recruiting for a Technical Launch Integrator – Scientist MSAT Small Molecule Drug Product Parenterals (SM DP Parenterals).
The Technical Launch Integrator (TLI) has overall accountability for ensuring fit for plant and commercial readiness during technical development, including implementation of new innovations & technologies.
TLI is also responsible for the execution of the transfer of pharmaceutical processes and products into the supply chain and the global marketplace.
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.
Objectives of the Position Technical and manufacturing integration of new and re-developed drug products from R&D into the supply chain.
Contribution, 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.
Single point of contact for supply plant readiness and execution and launch support between the Development and Commercial supply chain organizations.
Identify and implement opportunities for active decrease of 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.
Develop 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.
Coordinate and implement product introduction at the site from transfer through launch covering raw materials, formula, process, packaging, and device integration into the finished product.
Optimize the NPI process, make use of technology platforms, accelerate development timelines, and streamline the technical transfer process.
Qualifications What you will need to succeed Ability 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.
Motivated, self-starter able to work independently with proven problem-solving skills.
Minimum of a Bachelor's/University or equivalent degree (required).
M.
.
or PhD (preferred).
3- 5 years of relevant work experience with pharmaceutical product R&D and/or Manufacturing / MSAT functions, or equivalent (required).
Experience with technical transfer of biopharmaceutical products into manufacturing sites, including technical knowledge of DP unit operations (required).
Knowledge of Regulatory guidance related to aseptic processing, validation, manufacturing site systems and procedures, including an understanding of cGMP requirements (required) Knowledge of DP late-stage development (preferred).
Experience with document management systems such as RIMdocs, TruVault, SAP, MS Office applications, Trackwise, and/or Planisware (preferred).
FPX, PMP, or equivalent Project Management certification (preferred).
Proficient in English (required) May require up to 25% domestic and international travel, depending on project needs.