For our client, an international biopharmaceutical company, active in the fields of reproductive health, urology, gastroenterology, endocrinology and orthopedics, we are looking for a:
R&D CMC Project Manager
In this position, you will support a cross-functional international project team in charge of developing sterile depot injectable products including the manufacturing and analytical aspects.
* Organize and lead project meetings. Coordinating plans, actions and deliverables from various team members.
* Compile and analyses process and quality data. Drawing conclusions and recommendations.
* Write and review technical protocols and reports
* Prepare technical agreements with suppliers
* Participate to the quality by design and risk assessments
* Support the team in the above-mentioned main project deliverables
* Academic training (Master or PhD) chemistry, engineering, pharmacy
* At least 5 years of experience in pharmaceutical formulation development (ideally including manufacturing and supply of clinical trial material)
* At least 3 years of experience planning, leading or coordinating pharmaceutical development projects
* GMP manufacturing process optimization knowledge (DoE, QbD, Process data analysis)
* Regulatory knowledge of the current GMP and EU pharmacopoeia
* Experience on a sterile manufacturing site is a nice to have
* Proficiency in MS Office IT tools and IT data management systems (LIMS, etc.).
* Autonomy, capable of taking initiatives and proposing
* Fluent in French and English
Does this role interest you?
Do not hesitate to send us your CV via our online form.
We look forward to receiving your application!