Industrial Manufacturing Engineer.

For one of our clients, an international company in Schaffhausen, we are looking for 
Industrial Manufacturing Engineer
 

• Start date: ASAP 
• End date: 30.04.2024
• Extension: Possible
• Workplace: Schaffhausen
• Workload: 100%

In this position, you will establish Manufacturing Science and Technology expertise across different equipment platforms for drug product development & manufacturing with focus on Parenterals. You will represent the DPDS in development and clinical/commercial supply teams ensuring timely clinical supplies for drug product.


Tasks and Responsibilities:

1. Ensure timely plant readiness to support experimental / clinical activities
2. Ensure timely delivery of clinical material from internal pilot plants or from external contract manufacturing organizations (CMO)
3. Manage the overall relationship with internal / external manufactures and act as the single point of contact between the organization and the respective manufacturing site
4. Provide pilot plant input & requirements to Drug Product Development (DPD) / Primary Container Development (PCD)
5. Support scale-up and Tech-Transfer
6. Source raw materials and components as required. Point of contact for material and supplier related issues at CMO.
7. Put relevant manufacturing information and technical capabilities in place for the operations team to flawlessly produce the DP according to GxP, EHS and business requirements
8. Ensures that manufacturing processes are consistent with agreed platforms and are scalable and transferable to commercial operations
9. Supports investigations, CAPAs, change controls according to assigned responsibilities and performs critical raw data review for key documents
10. Assess new technologies / applications: feasibility, business case, conceptual design, installation and implementation
11. Prepare business plan forecasts and monitor actual spend vs budget.

Must Haves:

• You have a degree in Pharmaceutical/Biochemical/Life Science/Chemical or relevant Sciences or comparable experience in pharmaceuticals or in a related field with demonstrated ability (5+ years) OR a PhD with proven experience (3+ years)
• Excellent oral and written language skills in German and English.
• Demonstrated proficiency and experience in biologics drug product development within the biopharmaceutical industry is helpful
• Demonstrated proficiency and experience of biopharmaceutical process design is helpful
• Solid understanding and experience of technology transfer operations is preferred
• Solid understanding and experience in fill/finish operations is preferred
• Experience in clinical or commercial manufacturing is required. Prior experience working with a CMO is preferred.
• Proven track record of creativity and problem solving.
• Ability to collaborate with cross-functional teams is a must.

For one of our clients, an international company in Schaffhausen, we are looking for 
Industrial Manufacturing Engineer
 

• Start date: ASAP 
• End date: 30.04.2024
• Extension: Possible
• Workplace: Schaffhausen
• Workload: 100%

In this position, you will establish Manufacturing Science and Technology expertise across different equipment platforms for drug product development & manufacturing with focus on Parenterals. You will represent the DPDS in development and clinical/commercial supply teams ensuring timely clinical supplies for drug product.


Tasks and Responsibilities:

1. Ensure timely plant readiness to support experimental / clinical activities
2. Ensure timely delivery of clinical material from internal pilot plants or from external contract manufacturing organizations (CMO)
3. Manage the overall relationship with internal / external manufactures and act as the single point of contact between the organization and the respective manufacturing site
4. Provide pilot plant input & requirements to Drug Product Development (DPD) / Primary Container Development (PCD)
5. Support scale-up and Tech-Transfer
6. Source raw materials and components as required. Point of contact for material and supplier related issues at CMO.
7. Put relevant manufacturing information and technical capabilities in place for the operations team to flawlessly produce the DP according to GxP, EHS and business requirements
8. Ensures that manufacturing processes are consistent with agreed platforms and are scalable and transferable to commercial operations
9. Supports investigations, CAPAs, change controls according to assigned responsibilities and performs critical raw data review for key documents
10. Assess new technologies / applications: feasibility, business case, conceptual design, installation and implementation
11. Prepare business plan forecasts and monitor actual spend vs budget.

Must Haves:

• You have a degree in Pharmaceutical/Biochemical/Life Science/Chemical or relevant Sciences or comparable experience in pharmaceuticals or in a related field with demonstrated ability (5+ years) OR a PhD with proven experience (3+ years)
• Excellent oral and written language skills in German and English.
• Demonstrated proficiency and experience in biologics drug product development within the biopharmaceutical industry is helpful
• Demonstrated proficiency and experience of biopharmaceutical process design is helpful
• Solid understanding and experience of technology transfer operations is preferred
• Solid understanding and experience in fill/finish operations is preferred
• Experience in clinical or commercial manufacturing is required. Prior experience working with a CMO is preferred.
• Proven track record of creativity and problem solving.
• Ability to collaborate with cross-functional teams is a must.