We are looking for a Drug Product Development Leader.
The core purpose of the job is to manage the drug product development and clinical bulk supplies for various development projects.
As an expert member of the CMC group, you will provide drug product development expertise to several development projects. Highly qualified in pharmaceutical technology, you will come up with formulation and production strategies needed to support early development projects.
As Drug Product (DP) Development Leader within CMC, you are responsible for the drug product development and bulk supply strategy and execution thereof according to the CMC - and clinical plan for various development projects. You report into the Head of Drug Product Development.
- Working in the CMC development team on a project basis, together with a Drug Substance Development Leader, an Analytical Development Leader, a Clinical Supplies Leader and a CMC Dossier Leader. You will have frequent interaction with other CMC team members to build the early CMC development plan and ensure the Drug Product development activities execution thereof.
- Drug product – formulation development for pre-clinical safety studies and clinical supplies.
- (bulk) Manufacturing of development batches and GMP batches for clinical purposes.
- Evaluation and review of development data (composition/process/PK data) and adjustment of formulation/process as needed.
- Evaluation of stability data in cooperation with Analytical Development Leader and adjust further strategy and plan as needed.
- Preparation, review, approval and appropriate storage / archiving of DP CMC source documents for clinical trial applications (quality section) and prepare responses to regulatory questions.
- Selection (in alignment with Head DP development) and management of External Service Providers executing the drug product development / manufacturing activities.
- Collaboration (in alignment with CMC team when needed) with internal Quality and Compliance department for project related quality topics and to assure that ESPs are performing according to cGMPs.
- Interaction with the CMC project managers in Planning & reporting to provide Drug Product development budget information.
- Ensure the Product Specification File is kept up to date.
- Interaction with other CMC team members to build the CMC development plan and ensure execution thereof.
- Adherence to existing Policies and Procedures and ensure timely completion of relevant training.
- Staying abreast of current and new technologies applicable for drug product development and clinical manufacturing and latest regulations and guidelines.
- Establishing and building important relationships with the Late Discovery group and project team members from development.
- Master of Science (MSc) or PhD in chemistry, pharmaceutical sciences or bio-engineering or equivalent by experience
- At least 3 years of relevant experience in a drug product development role
- Outstanding Verbal And Written English Language Skills Required
- Ability to actively listen and engage in constructive communication with the different team members
- Excellent team player
- Strong planning & organisation skills and excellence in supervising projects
- Hands-on and pragmatic
We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happeners’
For more information please contact me at: +31 (0)20 20 44 502 or email@example.com.