MSAT Senior Manager, Device & Primary Container (Synthetics, TARIS)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way. Learn more at note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-052619

Switzerland - Requisition Number: R-052605

Belgium & Italy - Requisition Number: R-052597

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

Johnson & Johnson Innovative Medicine is recruiting for aSenior Manager Device & Primary Containerwithin MSAT (Manufacturing Science and Technology) focused on the TARIS product portfolio! This position is located in Titusville NJ. Alternate locations may be considered in Beerse Belgium Latina Italy or Schaffhausen Switzerland.

Position Summary:

TheSenior Manager Device & Primary Containerwill lead a global team of Technical Launch Integrators (TLIs) and Technical Owners (TOs) responsible for the technical transfer of Synthetic products from R&D to Supply Chain through ongoing lifecycle management activities. The team is accountable for manufacturing site and commercial readiness of new products in the pipeline. This team is also accountable for technical support including change control assessments process improvements complaint investigations CAPAs and audit support as required.

The Senior Manager will ensure all validation activities and ongoing production conducted at suppliers external manufacturers and internal manufacturing sites are in compliance with all applicable procedures and to the requirements of 21 CFR Partsand 820 and Johnson & Johnson Policy Standards related to Good Manufacturing Practice (cGMP) for Combination Products Pharmaceuticals and Medical Devices.

Device and primary packaging solutions such as primary container closure systems dosing devices and critical secondary packaging materials are becoming an increasingly relevant component in delivering innovative medicines to our patients. We are looking for a Senior Manager who combines technical expertise with project and people leadership.

Key Responsibilities:

• Provide technical leadership to global team of Technical Launch Integrators and Technical Owners.
• Enable collaboration with R&D to optimize the design of devices and primary containers for commercial assembly packaging and distribution.
• Drive development implementation and validation of device assembly and primary packaging processes at commercial scale.
• Support device assembly and packaging sourcing decisions in partnership with VCM PES Quality Planning and Finance and respective internal sites.
• Enable collaboration with Engineering to ensure equipment is accurately designed tested installed and qualified.
• Support technical transfers and manufacturing process capacity scale-up for internal and external manufacturing sites
• Delegate work assignments effectively evaluate performance of employees and plan developmental opportunities to increase efficiency encourage job satisfaction and personal growth and enhance professionalism.

Qualifications:

Education:

• Minimum of a Bachelors in Engineering degree required; advanced degree or focused degree in Engineering or Science preferred

Experience and Skills:

Required:

• Minimum 12 years of relevant work experience within pharmaceutical or medical device industry
• Prior people leadership experience required with an authentic leadership style and ability to successfully drive and influence virtual teams
• Ability to balance multiple priorities and operate with poise and integrity in a sophisticated and constantly evolving environment
• Strong interpersonal communication skills and ability to collaborate with and influence internal sites external manufacturers and global partners
• Ability to work independently and make decisions autonomously with demonstrated problem solving skills and a results oriented approach
• Proven compliance experience with one or more of the following is required: FDA CFR partor ISO 13485 (e.g. Design Control Change Control CAPA and Complaint Handling)
• Proficient in written and spoken English

Other:

• Requires up to 10% domestic and international travel including ability to work in an international environment across different time zones

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