Description
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.
Key Responsibilities:
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.
Qualifications
Education:
Minimum of a Bachelor's/University or equivalent degree required; M.S. or PhD is preferred
Experience and Skills:
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
Other:
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
Why join Johnson & Johnson
Working at Johnson & Johnson is more than a job. We are changing the trajectory of Human Health and working with Johnson & Johnson can change everything. Including you. Learn more by watching this video.
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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