Cmo Quality Control Lead
vor 1 Tag
**ROLE OVERVIEW**:
This position serves as a point of contact for Ichnos Sciences external client for Quality Control/Analytical aspects of a project from beginning to end with accountability for assigned project deliverables. This role reports directly to the Quality Control Manager.
**RESPONSIBILITIES**:
- Responsible for QC coordination of external Drug Product at CMO
- Responsible for BDS and DP CRO testing coordination
- Lead external analytical technology transfer to C(D)MO and CRO
- Liaison with RA and support regulatory filling writing on IMPD, IND, PM, IB.
- Support RA on Health Authority analytical response.
- Responsible for Analytical Validation Master Plan and Reference standard reporting
- Owner of comparability protocol and report to support regulatory filling.
- Support Quality Leadership Team with due diligence preparation
- Support Quality Unit management on CMO and analytical strategy
**EDUCATION AND DESIRED EXPERIENCE**:
- Masters or equivalent in immunology, biochemical engineering, biochemistry, biology or related discipline
- Relevant biologics experience in an industrial setting under GMP standards; CMO/CRO experience is a plus.
- Relevant process and QC experience and knowledge of current analytical techniques
- Demonstrated success with problem analysis/solving, anticipation and proactivity
- Demonstrated skills in communication and diplomacy
- Strong sense of discipline and initiative, exceptional planning and organization skills and a hands-on approach to work
- Fluency in English, both written and verbal; French is a plus
- Proven ability to work with flexibility in a changing and demanding environment
- Ability to work independently as well as part of a team
**LOCATION**:
You will join us, in a picturesque city of La Chaux-de-Fonds, Neuchâtel, Switzerland.
This is a rare opportunity to join our growing scientific team at the very start of something special. You will become a part of the foundation of a new company imprint
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