Technical Launch Integrator

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The Technical Launch Integrator (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 from Development into the supply chain and the global market place, as well as site-to-site transfers.

Areas of key responsibility include DS and/or DP technical support and oversight for the supply chain, planning and execution of DS and/or DP production, and manufacturing site level support of new product launch.

The TLI is a member of the Manufacturing Site Operational teams, CMC Sub Team, and JSC Value Chain Team and leads the new product introduction team at the manufacturing site.

**PRINCIPAL RESPONSIBILITIES**:

- Technical and manufacturing integration of new and re-developed drug products from R&D (DPDS or VPAD) into the supply chain.
- Contribution, review and approval of drug product technical and regulatory documents, routine technical support, integration of JSC technical expertise into project execution and QbD technical implementation at the manufacturing site level.
- Single point of contact for JSC plant readiness and execution from technical transfer into commercial production including launch support.
- Leading the manufacturing site team and taking the role of manufacturing site representative on the CMC Sub Team and the Value Chain Team (VCT).
- Identifying and implementing opportunities for active decrease of COGs and partnering with Development and JSC groups to develop and implement strategies to improve process robustness, fit for plant and commercialization of new products into the supply chain.
- Partnering with the Technical Integrator (TI) to provide all manufacturing site related needs to the CMC Sub Team as the single point of contact at the site.
- Developing the manufacturing site execution plan per product, in line with the overall strategy and plan as outlined by the CMC Sub Team and JSC VCT. The TLI will ensure alignment and endorsement of this strategy within the manufacturing site and TLI function.
- Providing required manufacturing technical support, document technical input, review and approval and serving as the JSC technical expert.
- Coordinating and executing product introduction at the site from transfer through launch covering raw materials, formula, process, packaging and device integration into the finished product and supporting the Value Chain Lead (VCL) for site related launch activities.
- Delivering clinical through commercial product supplied by the manufacturing site, ensuring manufacturing performance, cost, and process robustness requirements are met.
- Optimizing the new product introduction process, making use of JSC technology platforms, accelerating development timelines, streamlining the technical transfer process.

Serving as the Supply Chain technical representative on the CMC Sub Team, site representative on the VCT, and leader of the product specific site team.

**Qualifications**
KNOWLEDGE SKILL AND ABILITY REQUIREMENTS: COMPETENCY (knowledge, skills, abilities and experience required):
**1. Specific knowledge**
- Knowledge of both pharmaceutical product R&D and Manufacturing / Technical Operations functions
- Planning and logistics skills capable of effective integration of DS and DP deliverables to support detailed execution at the manufacturing site level.
- Experience with introduction of pharmaceutical products to manufacturing sites and late stage development with technical knowledge of manufacturing site unit operations.
- Knowledge of manufacturing site systems and procedures; understanding of GMP requirements 2. Personal and interpersonal skills / Leadership skills
- Demonstrated leadership in providing integration of activities and information across multifunctional groups and matrix teams.
- Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams.
- Ability to influence peers, superiors, and partners. 3. Personal attitude and mindset
- Motivated, self-starter able to work independently with demonstrated problem solving skills.

**DEGREE**/Experience: Minimum requirements: BS/BA with experience, M.S. with experience or PhD with experience in pharmaceutical development or pharmaceutical manufacturing or related post graduate academic experience/education.

**LANGUAGES**: Fluent in written and spoken English

**PHYSICAL REQUIREMENTS/WORKING CONDITIONS**: Travel: Min 10%-25% - project dependent

**Primary Location**
Switzerland-Schaffhausen-Schaffhausen
- **Organization**
Cilag GmbH International (8525)

**Job Function**
R&D

**Requisition ID**
2206030682W