CMC Leader / CMO Manager
Our client is a public Swiss Specialty Biopharmaceutical company listed on the SIX Swiss Stock Exchange focusing on the discovery and development of drugs that address high unmet medical needs in the field of anti-infectives and immune-oncology.
We are currently looking for an enthusiastic CMC Leader/ CMO Manager for a permanent position to be based in the Basel area.
As an ideal candidate you should have 5+ years of experience in the relevant areas, and ability to adapt to a fast-paced working environment.
- Develop robust and reproducible API chemical synthesis methods for our client’s clinical drug candidates together with CMOs (Contract Manufacturing Organisations) with focus on scalability and cGMP industrial manufacturing feasibility;
- In discussion and collaboration with the CMOs:
- Design suitable chemical process;
- Define process optimization of these processes to achieve reproducibility, robustness; and scalability appropriate for the project’s development phase. Knowledge of DoE approaches are a plus;
- Define and approve phase adequate specifications and analytical methods;
- Support technology transfers;
- Review and comment on batch records, in later phases also validation documents;
- Write technical reports and Quality sections of IND/IMPD/NDA/MAA and support regulatory submission;
- Plan and monitor budget for the assigned projects;
- Represent CMC function as team member in Global Project Teams.
Qualifications and Experience:
- Desired personal qualities should include: high emotional intelligence and teamwork attitude, hands-on approach to problem solving, strong self-motivation, hard-worker with ability to adapt to a fast-paced working environment;
- PhD in organic synthesis is required;
- Demonstrated strong experience in tech transfer, industrial scale-up and process development & validation of synthetic molecules;
- Regulatory experience with submission being familiar with EU and US regulations relating to clinical trials and cGMP;
- Good understanding of QbD principles, risk management by FMEA and determination of PAR/NOR (Proven Acceptable Range / Normal Operating Range) for new manufacturing processes;
- Solid knowledge of main analytical techniques;
- Robust negotiation skills and ability to manage outsourced activities at CMOs, with excellent monitoring of deliverables on time, quality and cost;
- Excellent knowledge of English language is required;
- Knowledge of German language would be a plus;
- Availability to travel at our collaboration partners (EU, US, Far East), ca 10-20% of time;
- At least 5 years work experience in the relevant areas;
- Relevant working/residency permit or Swiss/EU-Citizenship required.