CMC Project Manager
A leading biopharmaceutical company is currently recruiting a CMC Project Manager to join their team. The company is focussed on the discovery and development of innovative therapeutic and diagnostic solutions in chronic diseases where there are considerable unmet medical needs. Based in France, this is an exciting opportunity to bring expertise and skills to an established and in-demand company.
- Developing detailed pharmaceutical development plans for projects (from the identification of the drug candidate to marketing).
- Defining the studies necessary to make a new chemical entity a finished product accepted in clinical trial and until its approval for marketing, in connection with the various services involved and / or with providers chosen for their expertise.
- Coordinating all the synthesis studies of the active ingredient, analytical, pre-formulation and formulations with our partner providers.
- Managing the production of batches of active ingredient and batches of therapeutic units, ensuring compliance with GMPs where applicable.
- Guarantee compliance with deadlines for carrying out studies or manufacturing.
- Writing or validate all study reports entering the product file.
- Writing and update the pharmaceutical parts of the files prior to clinical trials.
- Ensuring that projects are carried out in accordance with protocols, Standard Operating Procedures (SOP), ICH / Good Manufacturing Practices regulations, as well as specific procedures under study.
- Working with the quality department to help identify potential quality problems.
- Participating in the development of processes and SOPs.
Skills and Requirements:
- Pharmacist or chemical engineer, ideally you have a specialisation in formulation or process. Expertise in oral extended release forms would be a plus.
- Attracted by multidisciplinary projects, you can intervene effectively in several fields of activity (from synthetic chemistry to galenics, including analysis and physicochemistry).
- Experienced in leading complex projects in the field of pharmaceutical development, you have a good knowledge of the drug development processes and of all regulatory aspects relating to clinical trials.
- Coordinate a project in close collaboration with various internal and external stakeholders. Experience in outsourcing management (CDMOs) would be a plus.
- Motivated, rigorous and organised.
- Solid spirit of synthesis and know how to intervene on several projects at the same time.
- Fluent in English, both written and spoken. Vocabulary is contemporary and adapted to an international work environment.
- 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 Patrick Aguie at 0203 854 1077 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.