External Manufacturing Operations Lead

vor 6 Monaten

Bulle, Schweiz Coopers Group AG Vollzeit

**External Manufacturing Operations Lead**

For our pharmacutical client, we are looking for External Manufacturing Operations Lead (French speaker).The person will be responsible for interacting with biological Contract Manufacturers in order to supply biological Drug Substances.

**Responsibilites**
- Interacts with biological Contract Manufacturers (CMOs, internal/external) in order to supply biological Drug Substances in the required quality, quantity, timing and cost; following defined production schedules, quality agreement and established manufacturing contracts.
- Support and Manage technical projects (process and analytical transfers, validations and optimization projects) at CMOs and coordinate any associated required regulatory documentation
- Ensures efficient Operational interaction with CMOs producing biological Drug Substances:

- Ensure availability of up-to-date GMP documentation at CMOs to ensure compliance of production (e.g. process descriptions, raw material reports, product specifications).
- Ensure efficient communication with CMOs by organizing regular meeting (call or F2F) as appropriate and ensure that minutes of those meeting with action list (if required) are prepared.
- Track production and technical transfer activities at CMOs in line with procedures
- Manage deviation and change control in system and provide timely response to CMOs.
- Monitor process performance at CMOs by reviewing the production data trending and annual product review.
- Ensures long term management of CMOs for commercial production.
- Define process improvement implementation roadmap in collaboration with internal functions and CMOs.
- Lead project for implementation (tech transfer) / modification of manufacturing processes and analytical methods at CMOs.
- Write/review of the CMC sections to ensure coherence with effective manufacturing process.

**Requirements**:

- Min. 5 years of experience in pharmaceutical industry
- Min 5 years of experience in Quality Assurance and CMO management
- **Fluent French - Mandatory**:

- Skilled in cGMP quality and regulatory requirements in the manufacture of NBEs
- Understanding of analytical development for recombinant protein products, including analytical characterisation and routine release testing
- Skilled at writing and reviewing technical documentation, including cGMP documents and regulatory submissions relating to biological products

Sounds like a great job?

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