Senior Clinical Manufacturing Manager
Would you like to join us in a challenging position as Pharmaceutical Development Manager in Clinical Manufacturing & CMO/CRO Management?
Clinical Manufacturing & CMO/CRO Management is focused on CMC development activities of aseptic and parenteral for projects at all stages of R&D. We are an experienced and diverse team of generalists and scientists building strong scientific business relationships with external stakeholders to deliver excellent development opportunities to our projects. We are now growing and seeking a highly motivated and energetic candidate with a strong background within aseptic manufacturing of peptide/ protein drug product formulation to join our team.
As part of Clinical Manufacturing & CMO/CRO Management team your essential tasks will be:
- Identify and evaluate potential external service providers, taking into account technical capabilities, quality requirements and cost-effectiveness in collaboration with the Procurement Manager
- Develop and maintain project management skills and scientific knowledge to oversee formulation and process development activities effectively
- Liaise with service providers on a regular basis to monitor progress , as well as resolve technical, quality and resource issues smoothly
- Review and manage technical data and documentation to ensure timely action, high scientific quality and efficient retrieval
- Plan and coordinate process development work for peptides/proteins, including GMP manufacturing, process scale-up/optimization using Quality by Design principles and validation activities at contract manufacturers
- Organize quality agreements and audit schedules, provide, monitor and improve their performance and maintain a qualified service provider list
- Initiate/introduce new scientific know-how and keep an updated scientific and regulatory knowledge in the areas of product manufacturing of asetic formulations
We expect the ideal candidate to have:
- Minimum a M.Sc. in pharmaceutical sciences, chemical engineering or equivalent education
- Minimum 10 years experience in pharmaceutical industry
- Proven scientific skills in process development, process scale-up and asetic manufacturing of peptide and protein formulations.
- Experience in nasal product manufacturing is an asset
- Experience in QbD, process up and down scaling, process validation and tech transfer
- Proven project coordination/ management skills
- Substantial experience of managing international business relationships with external service providers
- Ability to critically analyse data, apply problem solving methodologies and make sound decisions and recommendations
- Experience with GMP and regulatory guidelines and writing regulatory documentation
- Experience in elaboration of Quality Documentation
- Excellent communication skills and fluent in English, both spoken and written
- Quality and continuous improvement mindset
- Ph.D. in pharmaceutical science is an asset
- Keen on working in an international multicultural corporate environment
For additional information, please contact Director Christine Germann direct phone +45 28 78 79 04. Send your application and CV in English as soon as possible and no later than 30th Apr 2017 as we will review incoming applications on an on-going basis.