Johnson and Johnson, Innovative Medicine is recruiting for an MSAT: Technical Launch Integrator - Packaging & Device!
This position is located in Beerse, Belgium; Latina, Italy; or Schaffhausen, Switzerland. Alternate locations may be considered in Titusville, New Jersey. Springhouse or Malvern, Pennsylvania; Gurabo, Puerto Rico.
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 global and diverse team that is helping improve patient care and drive innovation? At Johnson & Johnson, we blend heart, science, and ingenuity to profoundly change the trajectory of health for humanity. Apply today for this exciting opening!
Device and Packaging solutions are becoming an increasingly meaningful component in delivering innovative medicines to our patients. We are looking for a Technical Launch Integrator (TLI) who combines technical expertise with project leadership. Together we strive to bring the best possible product to a successful launch. The TLI will work in the Device & Packaging New Product Launch and Grow team within the MSAT Small Molecule Platform. This team handles the technical transfer of newly developed products from R&D to the Commercial Supply Chain.
Key Responsibilities:
- Lead different global and local project teams and act as a core team member in the value chain team.
- Provide regular updates to senior leaders, partners, and sponsors through comprehensive reports, presentations, and ad-hoc communications
- Handle all technical outputs for file submission and launch readiness, on time and with the right quality.
- Provide up to 1 year of post-launch support to ensure manufacturing stabilization and fluent transfer of ownership.
- Work with the Drug Delivery System development team (DDS) to optimize the design of device and primary container for commercial assembly, packaging, and distribution.
- Collaborate with the MSAT Packaging Center of Excellence team to design, implement, and validate commercial secondary and tertiary packaging components, with an emphasis on sustainability considerations and patient requirements
- Together with internal partners and suppliers, search for optimal off-the-shelf and custom designed device components and secondary packaging materials solutions.
- Drive development, implementation, and validation of the device assembly and packaging processes at commercial scale and according to outstanding examples and standard procedures.
- Partner with Project Engineers to ensure that equipment is accurately designed, tested, installed, and qualified.
- Deliver a robust tech transfer documentation set in line with applicable combination product and packaging design transfer procedures; includes a design transfer plan and report, control strategy, FMEA, equipment qualification and process validation, distribution testing, procedures, protocols, ad-hoc test protocols, data analysis, and summary reports.
- Responsible for the consolidation of budget plans for New Product Introduction (NPI), ensuring alignment with strategic objectives and financial targets
QUALIFICATIONS
Education:
- Minimum of a Bachelor’s/University or equivalent degree is required; advanced degree or focused degree in Engineering or Science preferred
Experience and Skills:
Required:
- Minimum 6+ years of relevant work experience
- Experience in leading large and complex projects from initiation to completion with a multifunctional team in a global context
- Demonstrated the ability to operate with minimal guidance, requiring only strategic direction to self-direct, plan, and execute projects effectively. Proactively anticipates needs and potential issues, escalating matters as appropriate to ensure timely resolution
- Proven experience in Device & Packaging Operations, Engineering, Project Leadership, and/or R&D
- Demonstrated experience in Technical Launch Management, Product Technical Transfer, New Product Introduction, and/or New Product Launch
- Strong communication and an authentic personal leadership style, with ability to successfully drive, contribute, and influence in different virtual teams
- Proven leadership in stakeholder management, which involves effectively engaging with diverse stakeholders and managing upwards to build strong relationships with senior leaders.
Preferred:
- Experience within pharmaceutical, medical device or fast-moving consumer goods industry
- Expertise with combination products and different types of drug delivery devices
- Demonstrated experience in one or more of the following areas: Design Control, Design Transfer, Purchasing Control, Change Control, Risk Management, Qualification, Verification, and/or Validation
- Experience MS Project or equivalent applications
- Knowledge of business support systems such as Trackwise/Comet, SAP, or equivalent system
- Experience in Small Molecules pharmaceutical development or pharmaceutical manufacturing
Other:
- Requires proficiency in English (oral and written); proficiency in Spanish, Dutch, Italian, and/or German are nice to have
- May require up to 10% domestic and/or international travel
- 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
Additional information can be found through the link below. For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com
