Drug Product 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

Job Function
R&D Product Development

Job Sub Function
R&D Process Engineering

Job Category
People Leader

All Job Posting Locations:
Latina, Italy

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

Please 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):
Puerto Rico - Requisition Number: R-043883
Italy - Requisition Number: R-045116
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

We are searching for the best talent for a Drug Product Technical Launch Integrator (TLI) This hybrid position will be located in Gurabo, PR; alternative location may be considered in Latina, IT.

Would you like to join our world-class team?

The TLI has overall accountability 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 collaboration with R&D and the commercial manufacturing sites (internal or external) to ensure a robust product and manufacturing process is developed and successful transferred considering Best Process at Launch (BPAL) principles. Areas of key responsibility include Drug Product Process technical support and oversight for the supply chain.

As a TLI, you will be a member of Supply Chain, Value Chain Team (VCT), Site operational teams, and lead the new product introduction team at the sites. You 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 optimally develop and transfer to the commercial launch site.

The focus of this TLI position is on drug product within the Synthetic Platform

Key Responsibilities

• Facilitate commercial site technical support during execution of transfer activities.
• Ensure incorporation of technical expertise to include Best-Product-At-Launch and Quality-by-Design principles by providing input from early development through late development, encouraging alignment between R&D and Supply Chain.
• Draft, review, and approve regulatory documents for global markets.
• Build value by proposing potential product supply strategies ensuring security of supply, low COGS, tax advantages, while balancing innovation, EHS, QA, compliance, and financial requirements.
• Develop the execution plan per product, in line with the overall strategy as outlined by the R&D, CMC, and Value Chain teams. The TLI will ensure alignment and endorsement of this strategy within the sites and TLI function for Supply Chain MSAT.
• Providing required manufacturing site based technical support, technical documentation input, review and approval and serving as Supply Chain technical product authority.
• 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.
• Delivering clinical through to commercial solids drug product supply from the manufacturing site, ensuring manufacturing performance, cost, and process robustness requirements are met
• Influences at all organizational levels ensuring project targets are achieved and excellent leadership and negotiation skills with the ability to operate optimally 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

Qualifications
Education:

• Minimum of a bachelor's degree is required; advanced degree preferred in a Scientific or Engineering field such as Chemistry, Pharmaceutics, or Chemical Engineering
• Project Management Certifications is preferred

Required
Experience and Skills:

• At least 6 years of relevant work experience in the development or manufacturing arena, focusing on solids drug product.
• Strong communication skills and effectively communicates across all levels (shop floor to leadership), with ability to lead and influence without direct line authority
• High level of maturity to lead moderate to large complex projects and teams, programs, or initiatives, both internally and externally
• Strong risk assessment / risk management skills, able to balance considerations toward business, scientific, quality, EHS, and compliance needs
• Knowledge of plant functionality, plant capacity, and COG calculations
• Business Approach: negotiation and sourcing strategies and financial impact (e.g., finance for non-financial professionals)
• Decision making and problem-solving: able to seek solutions to complicated problems independently or through others and develops recommendations or build solutions
• Investigation handling and statistical assessments supporting Continued Process Verification, ensuring robust processes

Preferred

• Knowledge of contract manufacturing activities and crafting working relationships with global external partners.
• International experience and interest in collaborating with various cultures / nationalities / perspectives.
• Influences others with shared or different interests often beyond scope and level, networking, convincing for priority setting, both internally and externally to the company
• Besides excellent chemical synthesis know-how, knowledge and willingness for peptide, Oligonucleotide and conjugate know-how is an advantage

Other

• Proficient in English, written and spoken
• Availability to work in an international environment across different time zones
• International and domestic travel up to 30% - project dependent - is required

Required Skills
Drug Product Manufacturing, Process Engineering

Preferred Skills
Agile Decision Making, Crisis Management, Developing Others, Disruptive Innovations, Emerging Technologies, Engineering, Inclusive Leadership, Leadership, Process Control, Product Costing, Program Management, Project Scheduling, Quality Assurance (QA), Research and Development