Geel, BEL
1 day ago
Technical Launch Integrator, Synthetics Drug Substance
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 https://www.jnj.com **Job Function:** Supply Chain Engineering **Job Sub** **Function:** Manufacturing Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** Geel, Antwerp, Belgium **Job Description:** Within Manufacturing Science and Technology (MSAT) of Johnson & Johnson Innovative Medicines Supply Chain (Supply Chain), a member of Johnson & Johnson's Family of Companies, we are excited to recruit a Technical Launch Integrator (TLI) with the primary location in Geel, Belgium. Would you like to be a part of our 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 strong collaboration with R&D and the commercial manufacturing sites (internal or external) to ensure a robust product and manufacturing process is developed and successfully transferred considering Best Process at Launch (BPAL) principles. Areas of key responsibility include API technical support and oversight for the supply chain. As a TLI, you will be a member of the 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 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 Small Molecule Platform.   **Key Responsibilities:** + Act as lead or sub-team lead (and/or support the lead TLI ) MSAT point of contact for Supply Chain ensuring fit for lant and plant 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 and Quality-by-Design principles by providing input from early development through late development, encouraging alignment between Supply Chain and R&D. + Evaluate thoroughly the BPAL (Best Product & Process at Launch) information + Support the MSAT Technical Review Process. + Contribute to, review, and approve regulatory documents for global markets. + 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. + Contribute to create value by proposing potential product supply strategies ensuring security of supply, low COGS, tax advantages, while balancing innovation, EHS, QA, compliance, and financial requirements. + Assists to 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. The TLI will ensure alignment and endorsement of this strategy within the manufacturing sites and TLI function of Supply Chain MSAT. + Providing required manufacturing site based technical support, technical documentation input, review and approval and serving as the Supply Chain technical product expert. + Coordinate sub-teams for 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 API/SDP supply from the manufacturing site, ensuring manufacturing performance, cost, and process robustness requirements are met + Strong influencing skills ensuring project targets are achieved and excellent leadership and negotiation skills with the ability to operate effectively 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, with an Advanced degree preferred in a Scientific or Engineering field such as Chemistry, Pharmaceutics, or Chemical Engineering, with at least 5 years of relevant work experience in the development or manufacturing arena focusing on API. Experience and Skills: Required: + 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 (shop floor to leadership), with ability to lead and influence without direct line authority. + Maturity to lead moderate to medium 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 (finance for non-financial professionals) + Decision making and problem-solving: able to seek solutions to problems independently or through others and develop recommendations or design solutions. + Investigation handling and statistical assessments supporting Continued Process Verification, ensuring robust processes. Preferred: + International experience and interest in collaborating with various cultures / nationalities / perspectives. + Partial experience in Drug Products. + Knowledge of contract manufacturing activities and crafting working relationships with global external partners. + 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 to learn for peptide, Oligonucleotide and ADC know-how is an advantage **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 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. \#LI-MV2 \#LI-Hybrid
Por favor confirme su dirección de correo electrónico: Send Email
Todos los trabajos de J&J Family of Companies