External Manufacturing Operations Lead

vor 1 Woche

Fribourg, Schweiz Talentor Sweden AB Vollzeit

**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

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