Msat: Technical Launch Integrator

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.

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 mínimal 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
- 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

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applican