Technical Project Lead

vor 4 Stunden

Basel, Schweiz CTC Resourcing Solutions Vollzeit

**Technical Project Lead - Pharma Manufacturing (DP) - 5270 ADA**

Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a **Technical Project Lead with expertise in Pharma Manufacturing** (Drug Product).

You will establish Manufacturing Science and Technology (**MSAT**) 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.

This is a **contract based opportunity (1 year)** with great chances of extension and based in **Schaffhausen, Switzerland.**

**Main Responsibilities**:

- Ensure timely **plant readiness** to support experimental / clinical activities
- Ensure timely **delivery of clinical material** from internal pilot plants or from external contract manufacturing organizations (CMO)
- Manage the overall relationship with internal/external manufactures and act as the single point of contact between the organization and the respective manufacturing site
- Provide pilot plant input & requirements to Drug Product Development (DPD) / Primary Container Development (PCD)
- Support scale-up and Tech-Transfer
- Source raw materials and components as required. Point of contact for material and supplier related issues at CMO.
- 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
- Ensures that manufacturing processes are consistent with agreed platforms and are scalable and transferable to commercial operations
- Supports investigations, CAPAs, change controls according to assigned responsibilities and performs critical raw data review for key documents
- Prepare business plan forecasts and monitor actual spend vs budget.

**Qualifications and Experience**:

- **Relevant working/residency permit or Swiss/EU-Citizenship required.**:

- 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)
- 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.
- Ability to collaborate with cross-functional teams is a must.
- Excellent oral and written language skills in **German and English**.

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