Technical Launch Integrator (TLI) Emerging Synthetics
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At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. Our mission is to improve access, build healthier communities and put a healthy mind, body and environment within reach of everyone, everywhere. As one of the world’s largest healthcare companies, we are committed to using our reach and size for good.
Within Manufacturing Science and Technology (MSAT) of Johnson & Johnson Innovative Medicines Supply Chain, we are recruiting a Technical Launch Integrator (TLI) in the Emerging Synthetics group with primary location in Belgium. The TLI is 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 global marketplace.
Key Responsibilities
Act as the lead (or support the lead) MSAT point of contact for Supply Chain, ensuring fit for plant and commercial readiness for technical transfer to commercial operations.
Facilitate commercial site technical support during execution of transfer activities.
Ensure incorporation of Supply Chain technical expertise to include Best‑Product‑At‑Launch (BPAL) and Quality‑by‑Design principles.
Design and provide input from early development through late development to encourage alignment between Supply Chain and R&D.
Evaluate thoroughly the BPAL information.
Support the MSAT Technical Review Process.
Contribute to, review, and approve regulatory documents for global markets.
Represent the manufacturing sites on the CMC R&D Sub‑team and the Value‑Chain Team (VCT).
Partner with R&D and Supply Chain to identify and implement opportunities for active decrease in COGs and ensure fit for plant and commercial robustness of new products.
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 manufacturing site execution plan per product, ensuring alignment and endorsement within the manufacturing sites and TLI function of Supply Chain MSAT.
Provide required manufacturing site‑based technical support, technical documentation input, review and approval, and serve as the Supply Chain technical product expert.
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 to ensure project targets are achieved and demonstrate excellent leadership and negotiation skills in a multidimensional work environment.
Own the estimation of Supply Chain resource requirements for assigned projects and ensure proactive technical status communications to leadership.
Qualifications
Education
Minimum of a bachelor’s degree, with an advanced degree preferred in a Scientific or Engineering field such as Chemistry, Pharmaceutics, or Chemical Engineering, and at least 10 years of relevant work experience in the development or manufacturing area focusing on API with experience in DP as an advantage.
Required Experience and Skills
Broad proven technical background in API Chemical manufacturing, process & product development, quality, cGMP and regulatory knowledge related to Small Molecules.
Strong communication skills and effective communication across all levels, with the 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.
Eye for business: negotiation and sourcing strategies and financial impact.
Decision making and problem‑solving: able to seek solutions to complicated problems independently or through others and develop recommendations or design solutions.
Investigation handling and statistical assessments supporting continual process verification, ensuring robust processes.
Preferred
International experience and interest in collaborating with various cultures and perspectives.
Partial experience in Drug Products.
Knowledge of contract manufacturing activities and crafting working relationships with global external partners.
Capability to influence others with shared or different interests often beyond scope and level, networking, convincing priority setting, both internally and externally.
Besides excellent chemical synthesis know‑how, knowledge and willingness for peptide, oligonucleotide and drug conjugate know‑how are advantages.
Other
Proficient in written and spoken English.
Works in an international environment across different time zones.
Project management certifications preferred.
International and domestic travel up to 25% - project dependent.
Employment Information
Seniority level: Not Applicable
Employment type: Full‑time
Job function: Engineering and Information Technology
Industry: Pharmaceutical Manufacturing
Locations
All job posting locations: Allschwil, Basel‑Country, Switzerland; Cork, Cork, Ireland; Geel, Antwerp, Belgium; Schaffhausen, Switzerland.
EEO Statement
Johnson & Johnson is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.
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