MSAT Technical Launch Integrator, Principal Engineer

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Athens, Georgia, United States of America, Titusville, New Jersey, United States of America

Job Description:

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 https://www.jnj.com/innovative-medicine.

We are searching for the best talent for an MSAT Technical Launch Integrator (TLI), Principal Engineer! This hybrid position will be located in Athens, Georgia (USA) or Titusville, New Jersey (USA).

Within Manufacturing Science and Technology (MSAT) of Johnson & Johnson Innovative Medicines Supply Chain (IMSC), the TLI will be responsible for ensuring fit for plant and commercial readiness during technical development and execution of the transfer of pharmaceutical processes and products into the supply chain and the global marketplace. A main objective of the role is strong collaboration with R&D and the commercial manufacturing sites to ensure a robust product and manufacturing process is developed and successful transferred considering Best Process at Launch (BPAL) principles.

The TLI is a member of the Value Chain Team (VCT) and Site operational teams, and will lead the new product introduction (NPI) team at the sites. They will also be a full member of several R&D teams, CMC Sub teams, and R&D SI (Scientific Integrator) Sub teams, working hand-in-hand with R&D to successfully develop and transfer to the commercial launch site (internal or external). The focus of this TLI position is on API and SDP (Spray Drying) within the Synthetic Platform.

KEY RESPONSIBILITIES:

• Lead end-to-end MSAT technical transfer activities including process fit for plant, serving as the primary point of contact for Supply Chain and ensuring manufacturing site readiness from transfer through commercial launch.

• Ensure incorporation of Supply Chain technical expertise to include BPAL and Quality-by-Design (QbD) principles by providing input from early development through late development, encouraging alignment between Supply Chain and R&D.

• Contribute to, review, and approve regulatory documents for global markets and fully support the MSAT Technical Review Process and serve as the Supply Chain technical product authority.

• Represent the manufacturing sites on the CMC R&D Sub-team and the VCT.

• Build value by proposing potential product supply strategies ensuring security of supply, low COGS, tax advantages, while balancing commercial robustness, innovation, EHS, QA, compliance, and financial requirements.

• Develop the manufacturing site execution plan per product, in line with the overall strategy as outlined by the R&D, CMC, and Value Chain teams.

• Ensure alignment and endorsement of this strategy within the manufacturing sites and TLI function of Supply Chain MSAT.

• Coordinate product introduction at the site from transfer through launch covering raw materials, process, EHS, engineering, packaging, sterilization (if required), and other items needed for a successful technical transfer and launch.

• Deliver clinical through to commercial API/SDP supply from the manu