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Technical Launch Integrator
il y a 3 semaines
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have sought to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, build healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science, and resourcefulness to profoundly change the trajectory of health for humanity.
Within Technical Operations of Janssen Supply Chain (JSC), a member of Johnson & Johnson's Family of Companies, we are excited to recruit a Technical Launch Integrator (TLI) with the preferred location of Belgium, other locations to be considered.
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, successful transferred, and launched commercially.
As a TLI, you will be a member of the JSC 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 a number of R&D teams and Regulatory 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 Drug Product (DP) with the responsibilities potentially growing to Active Pharmaceutical Ingredients (API) allowing a full End-to-End perspective.
Would you like to be a part of our team?
**Key Responsibilities**:
- Act as lead Technical Operations point of contact for JSC ensuring fit for plant and plant readiness for technical transfer to commercial operations.
- Facilitate commercial site technical support during execution of transfer activities.
- Ensure incorporation of JSC 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 JSC and R&D.
- Contribute to, review, and approve regulatory documents for global markets.
- Represent the manufacturing site on the CMC R&D Sub-team and the VCT.
- Partner with R&D and JSC to identifying and implementing 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 EHS, QA, compliance, and financial requirements.
- 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 JSC Technical Operations.
- Providing required manufacturing site based technical support, technical documentation input, review and approval and serving as the JSC 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.
- Delivering clinical through commercial DP 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
- Own the estimation JSC resource requirements for assigned projects, and ensure proactive technical status communications to leadership
- Overall focus will be on DP, but willingness to tackle API activities is required
**Qualifications**
Advanced degree (MS) required with a Doctoral degree strongly preferred in a Scientific or Engineering field such as Chemistry, Pharmacy, Pharmaceutics, or Chemical Engineering. Pharmacy and Pharmaceutics focus areas preferred.
***:**Experience and Skills**:
**Required**:
- At least 10 years of relevant work experience in the areas of formulation development and manufacturing of solid dose DP, with hands-on experience in formulation development and commercial manufacturing preferred.
- Broad proven technical background in solid dose DP manufacturing, process & product development, quality, cGMP and regulatory knowledge related to Small Molecules
- Strong communication skills and effectively communicates across all levels (shop floor to leadership), with ability to lead and influence without direct line authority
