Senior CMO Manager
A leading biopharmaceutical company is advertising a vacancy for a Senior CMO Manager position, based in their office in Belgium. The organisation provides dynamic therapies and support to people living with severe diseases by connecting globally with patients and their families living with the physical and social burdens of severe disease. This is an exciting opportunity to work with an organisation that operates in over 40 countries that prides itself on its pipeline that includes several novel molecules.
- Leading CMO vendor teams to perform day to day operational management of selected CMOs.
- Facilitating and leading periodic meetings between CMOs and the company's multifunctional teams.
- Managing and monitoring CMOs performances using SC, Quality, and technical KPIs.
- Performing 1st line troubleshooting at CMOs in scope and leading the investigations/Definition/implementation of CAPAs in case of technical, quality, and supply/business issues.
- Managing CMO documentation together with QA, reviewing and approving main documents (e.g. Deviations, Change Controls, Protocols and Report, and MBR…).
- Delivering technical expertise in order to ensure effective processes and optimise capacity utilisation and quality.
- Leading project groups, if appropriate.
- Driving CMO risk analysis and implementing identified mitigation plans.
- Participating in the CMO selection.
- Leading technical assessments/due diligences.
- Supporting the establishment of business and quality contracts.
- Monitoring capacities and implementing long range capacity plans in coordination with Supply Chain.
- Defining and implementing cost and process Improvement initiatives during the life cycle of all products in scope.
- Acting as a project manager, leading multifunctional teams to ensure tech transfers and validation, and supporting regulatory submissions related to these projects.
- Developing and evaluating business cases and preparing recommendations for making or buying of respective products.
- Maintaining and sharing technology intelligence and External Manufacturing network intelligence.
- Implementing the company's green strategy towards the CMOs in scope.
Skills and Requirements:
- At least 5 years of demonstrable Operation management in GMP environment (DP manufacturing).
- International Exposure in pharmaceutical project management.
- Must be able to manage external business partners and relationships to influence partners to deliver results that the company needs.
- Basic financial & business knowledge.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Marjolene D'Almeida-Ayeni at +44 203 854 2626 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.