Technical Launch Integrator Drug Substance Sm

il y a 3 semaines

Antwerpen, Belgique Johnson & Johnson Temps plein

**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 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 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 successful 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 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.
- Represent the manufacturing sites on the CMC R&D Sub-team and the 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, 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 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
- Influences at all organizational levels 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**:
**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 10 years of relevant work experience in the development or manufacturing arena focusing on API with experience in DP as an advantage.

**Experience and Skills**:
**Required**:

- Broad proven technical background in API Chemical manufacturing

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