New Product Introduction Lead - NPI

Location: Schaffhausen, Switzerland

Hours: 40h, Hybrid way of working (3 days onsite, 2 home office)

The Department:

Johnson & Johnson Innovative Medicines Supply Chain/ Cilag AG is recruiting for a Device & Packaging New Product Introduction Lead,, located in Schaffhausen, Switzerland.

Devices and Packaging solutions are becoming an increasingly meaningful component in delivering innovative medicines to our patients.

We are looking for an extra colleague who combines technical expertise with project leadership. Together we strive to bring the best possible product to a successful launch!

The Role:

You will work in the New Product Introduction (NPI) team at the Biotherapeutics Primary Container & Device Team of the broader MSAT organization. This team handles the technical transfer of newly developed products from J&J IM R&D to J&J IM Commercial Supply Chain.

Key Responsibilities:

Project Leadership and Technical Launch Management

• You lead different global and local project teams and act as a core team member in the value chain team.
• Partnering end to end with Biotherapeutics Drug Product TLIs, you ensure a single One MSAT technical voice at the right partner table.
• You provide regular updates to partners and sponsor through reports, presentations and ad-hoc communication.
• All technical outputs for file submission and launch readiness are completed by you, on time and with the right quality.
• You provide up to 1 year of post-launch support to ensure manufacturing stabilization and fluent transfer of ownership

Device & Packaging Technical Transfer

• You work with the Primary Container & Device development team (PCD) to optimize the design of device and primary container for commercial assembly, packaging and distribution.
• Together with internal partners and suppliers, you search for optimal off-the-shelf and custom designed device components and secondary packaging materials solutions.
• You integrate customer insights, standard platforms and requirements from various partners in Research & Development (R&D), the global J&J IM SC organization and the production site. You ensure accurate specifications and adequate controls are in place.
• You drive development, implementation and validation of the device assembly and packaging processes at commercial scale and according to outstanding examples and standard procedures.
• Project engineers are your key partners to ensure that equipment is accurately designed, tested, installed and qualified.
• You deliver a robust tech transfer documentation set in line with applicable combination product and packaging design transfer procedures. This 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.

Qualifications / Education:

• You hold a bachelor’s or master’s degree in engineering or science.
• You love guiding projects from initiation to completion with a multifunctional team in a global context.
• Working towards ambitious goals and solving sophisticated problems energizes you.
• Through strong communication and your authentic personal leadership style, you can successfully drive, contribute and influence in different virtual teams.
• You bring at least 5 years of solid experience in device and packaging operations, engineering, project management or R&D, preferably in the pharmaceutical, medical device or fast-moving consumer goods industry.

Preferred:

• Demonstrate experience with applicable regulations; Design Control, Design Transfer, Purchasing Control, Change Control, Risk Management; Qualification, Verification and Validation is a surplus!
• Proficiency in English and German language is needed.

What’s in it for you?

At Johnson & Johnson, we find it important to put the needs and well-being of our customers and employees first. Our recipe for success consists of crafting an inclusive work environment where everybody feels welcome and respected. At J&J, we recognize the importance of a good work-life balance. We will also give you the space and opportunities to grow and learn during workshops and training sessions.

Based out of Schaffhausen, Switzerland, you will be member of a team across the US, Switzerland and Belgium. You will have the flexibility to work from home up to 40%. You will find opportunities for personal and professional growth by working with a diverse group of people across our organization. You may be requested to travel internationally up to 10%.

At J&J, we blend heart, science and ingenuity to profoundly change the trajectory of health for humanity.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. Please apply via the link.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.