Technical Launch Integrator
vor 9 Stunden
***:
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
-
Technical Product Owner
vor 1 Tag
Schaffhausen, Schweiz Ascent Health Services LLC VollzeitJOB SUMMARY: We are looking for a motivated and experienced Technical Product Owner to join our team. In this role, you will drive the development and implementation of our digital products, ensuring alignment with business goals and technological excellence. You will work closely with cross-functional teams to deliver impactful solutions that meet the needs...
-
2 x Local Quality Owner Launch
vor 1 Tag
Schaffhausen, Schweiz Johnson & Johnson VollzeitJob Description - 2 x Local Quality Owner Launch & Grow / NPI (f/m/d), 80-100% (2406227450W)Cilag AG in Schaffhausen, Switzerland is part of the Johnson & Johnson Innovative Medicine (J&J IM) Supply Chain organization and is currently recruiting for:2 x Local Quality Owner Launch & Grow / NPI (f/m/d), 80-100%The function holder is responsible for the QA...
-
2 X Local Quality Owner Launch
vor 1 Woche
Schaffhausen, Schweiz Johnson & Johnson VollzeitCilag AG in Schaffhausen, Switzerland is part of the Johnson & Johnson Innovative Medicine (J&J IM) Supply Chain organization and is currently recruiting for a 2 x Local Quality Owner Launch & Grow / NPI (f/m/d), 80-100% We manufacture high quality pharmaceutical drug products (Small and Large Molecules) and active pharmaceutical ingredients (APIs). Cilag...
-
Global Product Specialist
vor 5 Stunden
Schaffhausen, Schweiz ABB Schweiz AG VollzeitGlobal Product Specialist At ABB, we are dedicated to addressing global challenges. Our core values: care, courage, curiosity, and collaboration - combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to empower everyone to create sustainable solutions.Write the next chapter of your ABB story. This position...
-
Trainee Supply Chain Manufacturing
Vor 7 Tagen
Schaffhausen, Schweiz Johnson & Johnson VollzeitToday Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a Johnson & Johnson strategic launch and growth site for parenteral products, and we have an impressive pipeline of new and innovative products. For our growing commercial business and our fast-extending new...
-
Production Scheduler
Vor 7 Tagen
Schaffhausen, Schweiz ABB Vollzeit**Production Scheduler (80 - 100%) m/w/d**: **Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities, ethnicity and generations....
-
Area Quality Owner
Vor 6 Tagen
Schaffhausen, Schweiz Johnson & Johnson VollzeitCilag AG in Schaffhausen, Switzerland, is part of the Janssen Supply Chain (JSC) organization, within Johnson & Johnson and is currently recruiting for an **Area Quality Owner (AQO), temporary position** We manufacture high quality pharmaceutical products and active pharmaceutical ingredients (APIs). Today Cilag AG is one of the largest pharmaceutical...
-
Schaffhausen, Schweiz Johnson & Johnson VollzeitCilag AG is currently recruiting a Maintenance Engineer in support of the Parenterals Filling department, to be located in Schaffhausen, Switzerland. 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...
-
Trainee Supply Chain Manufacturing
Vor 4 Tagen
Schaffhausen, Schweiz Johnson & Johnson VollzeitJob Description - Trainee Supply Chain Manufacturing (2506230260W)Trainee Supply Chain Manufacturing - 2506230260WDescriptionAt 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...
-
2 X Local Quality Owner Launch
Vor 3 Tagen
Schaffhausen, Schweiz Johnson & Johnson VollzeitWe manufacture high quality pharmaceutical drug products (Small and Large Molecules) and active pharmaceutical ingredients (APIs). Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all major global markets. The Schaffhausen facility is a center for launching and boosting growth in parenterals, having an impressive pipeline...
-
2 x Local Quality Owner Launch
vor 1 Tag
Schaffhausen, Schweiz Johnson & Johnson VollzeitWe manufacture high quality pharmaceutical drug products (Small and Large Molecules) and active pharmaceutical ingredients (APIs). Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all major global markets. The Schaffhausen facility is a center for launching and boosting growth in parenterals, having an impressive pipeline...
-
Lab Technician
Vor 3 Tagen
Schaffhausen, Schweiz Avantor VollzeitThe Opportunity:Avantor is looking for a Lab Technician – Fill-Finish Technologies (f/m/d) based at our customer site in Schaffhausen. In this role, you will provide scientific support to the testing and development of methods related to fill and finish procedures.This is a full-time, 9 months limited contract (extension possible, but not guaranteed). Next...
-
Schaffhausen, Schweiz Johnson & Johnson VollzeitJob Description - Experienced Maintenance Engineer, Parenteral filling (2406222659W)Experienced Maintenance Engineer, Parenteral filling - 2406222659WDescriptionCilag AG is currently recruiting a Maintenance Engineer in support of the Parenterals Filling department, to be located in Schaffhausen, Switzerland.At Johnson & Johnson, we believe health is...
-
Senior Engineer MSAT LM DP STO
Vor 3 Tagen
Schaffhausen, Schweiz Johnson & Johnson VollzeitDescriptionCilag AG, part of Johnson & Johnson, is recruiting for a Staff / Senior Engineer, LM DP STO within the Manufacturing Science and Technology (MSAT) team, located in Schaffhausen, Switzerland.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented,...
-
Junior Area Quality Owner
Vor 3 Tagen
Schaffhausen, Schweiz Johnson & Johnson VollzeitWe manufacture high quality pharmaceutical products and active pharmaceutical ingredients (APIs). Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a Johnson & Johnson strategic launch and growth site for parenteral products, and we have an impressive pipeline...
-
Area Quality Owner
Vor 3 Tagen
Schaffhausen, Schweiz Johnson & Johnson VollzeitJob Description - Area Quality Owner (2406226411W)Area Quality Owner (AQO) ParenteralsCilag AG in Schaffhausen, Switzerland, is part of the Johnson & Johnson Innovative Medicine (J&J IM) organization, and is currently recruiting for an Area Quality Owner (AQO) Parenterals. We manufacture high quality pharmaceutical products and active pharmaceutical...
-
Schaffhausen, Schweiz Johnson & Johnson VollzeitWe are looking for a maintenance engineer to support the Parenterals Filling Department.Key Responsibilities:Responsible for the definition and implementation of maintenance strategies and methods based on proven research for the Repair & Maintenance Engineering team.Applies practical skills of the field to complete tasks that minimize equipment failure...
-
Schaffhausen, Schweiz Johnson & Johnson VollzeitWe are looking for a maintenance engineer to support the Parenterals Filling Department.Key Responsibilities:Responsible for the definition and implementation of maintenance strategies and methods based on proven research for the Repair & Maintenance Engineering team.Applies practical skills of the field to complete tasks that minimize equipment failure...
-
2 x Local Quality Owner Launch
Vor 3 Tagen
Schaffhausen, Schweiz Johnson & Johnson VollzeitWe manufacture high quality pharmaceutical drug products (Small and Large Molecules) and active pharmaceutical ingredients (APIs). Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all major global markets. The Schaffhausen facility is a center for launching and boosting growth in parenterals, having an impressive pipeline...
-
2 x Local Quality Owner Launch
Vor 2 Tagen
Schaffhausen, Schweiz Johnson & Johnson VollzeitWe manufacture high quality pharmaceutical drug products (Small and Large Molecules) and active pharmaceutical ingredients (APIs). Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all major global markets. The Schaffhausen facility is a center for launching and boosting growth in parenterals, having an impressive pipeline...
