MSAT Technical Launch Integrator, Principal Engineer

Johnson & Johnson • Titusville, GA

6d • Hybrid

About The Position

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.

Requirements

• Minimum of 6 years of relevant work experience
• Experience in the development or manufacturing arena, focusing on API
• Broad, demonstrated technical background in API Chemical manufacturing, preferably including understanding of process & product development, quality, cGMP, and regulatory knowledge related to Small Molecules
• Strong communication skills and the ability to effectively communicate across all levels (shop floor to leadership) to lead and influence without direct line authority
• Proven ability to lead moderate to large complex projects and teams, programs, or initiatives, both internally and externally
• Strong risk assessment/management skills, and ability to balance considerations toward business, scientific, quality, EHS, and compliance needs
• Knowledge of plant functionality, plant capacity, and COG calculations
• Strong decision-making and problem-solving skills to seek solutions to complicated problems (independently or through others) and to develop recommendations or design solutions
• Experience handling investigations and statistical assessments to support Continued Process Verification and ensure robust processes

Nice To Haves

• Experience with Drug Products (DP), mainly in Spray Drying
• Knowledge of contract manufacturing activities and shaping working relationships with global external partners
• Experience and interest in collaborating across global teams and partners, with various cultures, nationalities, and/or perspectives
• Strong skills in business negotiation, sourcing strategies, and understanding of financial impact
• Knowledgeable with chemical synthesis, peptide, oligonucleotide, and/or conjugate

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 manufacturing site, ensuring manufacturing performance, cost, and process robustness requirements are met.
• Influence at all organizational levels ensuring project targets are achieved and excellent leadership and negotiation skills with the ability to operate successfully in a multidimensional work environment and collaborate with multi-functional teams.
• Own the estimation Supply Chain resource requirements for assigned projects, and ensure proactive technical status communications to leadership.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 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
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
• Consolidated retirement plan (pension)
• Savings plan (401(k))
• Long-term incentive program

What This Job Offers

• Job Type: Full-time
• Career Level: Principal