Primary Container & Device Technical Launch Integrator

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

Job Function:

Supply Chain Engineering

Job Sub Function:

Packaging Design Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Titusville, New Jersey, United States of America

Job Description:

You will be a member of a global team located across the US, Switzerland and Belgium.

Device and Packaging solutions are becoming a more important component in delivering innovative medicines to our patients. We are looking for a team member who combines technical expertise with project leadership. Together we strive to bring the best possible product and process to a successful new product launch. You will work within the Launch & Grow team, part of the Primary Container & Device, Biotherapeutics team, focused on Biotherapeutics and Advanced Therapies. This team owns the technical transfer of newly developed products from R&D to the Innovative Medicine Supply Chain.

Key Responsibilities:

Project Leadership and Technical Launch Management

• Lead complex global and local project teams; you are a core team member in the value chain team and the supply chain development team.

• Partner with the drug product and drug substance to ensure a single supply chain technical voice at the right partner table.

• Provide regular updates to project collaborators and sponsors through regular reports, presentations, and ad-hoc communication.

• Ensure that all technical deliverables for health authority submissions and launch readiness are completed on-time and with the right quality.

• Provide post-launch support to ensure manufacturing stabilization and fluent transfer of ownership to base business.

Device & Packaging Technical Transfer

• Work with the Primary Container & Device development team (PCD) to optimize design of device and primary container for commercial assembly, packaging, and distribution.

• Work with internal partners and suppliers to search for the best possible off-the-shelf and custom designed device components and secondary packaging materials solutions.

• Integrate customer insights, standard platforms, and requirements from various partners in Research & Development (R&D), the global Supply Chain organization and the production site.

• Ensure accurate specifications and adequate controls are in place.

• Drive development, implementation, and validation of the device assembly and packaging processes at commercial scale and according to best practices and standard procedures.

• Partner with project engineers to ensure that assembly and packaging 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. 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:

Bachelor's Degree in Engineering or scientific field.

Experience and Skills:
Required:

• Minimum of 5 years in device and packaging operations, engineering, project management and/or R&D

• Experience with advanced therapies; radiopharmaceuticals, cell and gene therapy

• Project Management experience

• Experience working in the pharmaceutical, medical device or fast-paced consumer goods industry

• Experience leading projects from initiation to completion with a multi-functional team in a global context

• Ability to achieve challenging goals and solving complex problems

• Excellent communication and ability to effectively drive, contribute and influence in different global & virtual teams through appropriate means of communication

• Past experience working with 3rd party vendors

• Ability to build, and lead global complex cross-functional teams

• Travel 25% domestic & international based on project and business needs

Preferred:

• Advanced Degree

• Experience with Design Control, Design Transfer, Purchasing Control, Change Control, Risk Management, Qualification, Verification and Validation

• Experience with primary containers; vials, syringes, cartridges, freeze bags

• PMP/FPX project management certification

Other:
•    Requires up to 10% domestic travel.

The anticipated base pay range for this position is :

77,000-124,200

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours