Technical Launch Integrator - Principal Scientist MSAT LM DP L&G

Cilag GmbH International, a member of the Johnson & Johnson Family of Companies, is recruiting for a Technical Launch Integrator - Principal Scientist MSAT Large Molecule Drug Product Launch & Grow (LM DP L&G)! 

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.jnj.com/.

Are you interested in joining a team that is passionate about groundbreaking biomedicine operations that positive improve the lives of patients? Do you want to work for an employer with an excellent record in employee continuous professional development and business improvement? Apply today to J&J!

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.

• 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 execute 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.

• Minimum of a Bachelor's/University or equivalent degree required; M.S. or PhD is preferred

Required:

• Minimum 6 years of relevant work experience
• Significant experience with pharmaceutical product R&D and/or Manufacturing / MSAT functions
• Experience with technical transfer and effective integration of DS and DP deliverables to support detailed execution at the manufacturing site level
• Experience with introduction of pharmaceutical products to manufacturing sites and late-stage development with technical knowledge of manufacturing site unit operations
• Knowledge of manufacturing site systems and procedures, including an understanding of GMP requirements
• Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams, and influence with or without direct authority
• Motivated, self-starter able to work independently with demonstrated problem solving skills

Preferred:

• Experience with document management systems such as RIMdocs, TruVault, SAP, MS Office applications, Trackwise, and/or Planisware
• FPX, PMP, or equivalent Project Management certification
• Lean, Six Sigma, or Process Excellence methodologies experience, training, or certification
• Knowledge of budget management

• Requires proficiency in English (written and spoken); proficiency in German is preferred
• May require up to 20% domestic and international travel, depending on project needs
• Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week

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Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Johnson & Johnson provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans.

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