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**Job Function: **
R&D Product Development
**Job Sub Function: **
R&D Process Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Beerse, Antwerp, Belgium, Latina, Italy
Job Description:
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):
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. #Li-Hybrid
We are searching for the best talent for a Drug Product Technical Launch Integrator (TLI)! This hybrid position will be located in Latina, IT; alternative location may be considered in Beerse, BE.
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
Experience and Skills:
Required:
- 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: **
Preferred 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
The anticipated base pay range for this position is:
Benefits:
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer 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 subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.