We are searching for the best talent for a Drug Product Technical Launch Integrator (TLI). This hybrid position will be located in Latina, Italy; alternative location may be considered in Beerse, Belgium. The TLI is accountable 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. They collaborate with R&D and commercial manufacturing sites to develop and transfer successful products, applying Best Process at Launch (BPAL) principles and ensuring robust product and manufacturing processes.
All Job Posting Locations: Beerse, Belgium; Latina, Italy.
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.
* Provide required manufacturing site based technical support, technical documentation input, review and approval and serve 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.
* Deliver clinical through to commercial solids drug product 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 exhibit 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 of 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.
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 communicate 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 develop 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, and 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
* Agile Decision Making
* Coaching
* Crisis Management
* Critical Thinking
* Disruptive Innovations
* Emerging Technologies
* Engineering
* Organizing
* Process Control
* Process Engineering
* Process Improvements
* Product Costing
* Program Management
* Project Schedule
* Research and Development
* SAP Product Lifecycle Management
* Tactical Planning
* Technical Research
* Technical Writing
Benefits
The anticipated base pay range for this position is discussed in our benefits overview. In addition to base pay, we offer an annual bonus with a set target (percentage of pay) depending on pay grade and location, vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well‑being reimbursement, programs for financial, physical, and mental health. We also offer service anniversary and recognition awards, and in some locations, eligible employees can participate in several insurance plans.
* This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
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