Drug Development Manager
For an international manufacturer of medicine with over 140 years of experience, we are seeking a Drug Development Manager. If you are ready for a new challenge in which you can expand your experience and contribute to the success of this international orientated organisation, do not hesitate to get in contact.
As Drug Development Manager you bring in existing knowledge in pharmaceutical Drug Products, ideally in generics, for optimal formulation development. The Drug Product Development Manager performs in multidisciplinary Teams involved in the development, manufacturing and marketing & sales of the DSP products, and in consultancy with Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs) and other disciplines, where applicable. You will be the main contact point on Pharmaceutical Technology for CROs and CMOs and work closely together with other contracted partners. You will keep an updated knowledge of relevant new Drug Product developments in all relevant regions of the world and make an interpretation of how this can affect the business. In this role you will act as a Pharmaceutical expert in support of relevant disciplines.
As a Drug Product Development Manager you will have the Technical lead in the development phase of Drug Products (mainly solid oral dosage forms) up to commercialization and, as such, you are responsible for:
- Review and approval of all technical documentation provided internally as well as externally (by CROs, CMOs and consultants)
- Manage and challenge the various stages of the project, including clinical Bio-Equivalence studies
- Lead and steer the production of exhibit (pilot) and test batches and relevant site transfer activities
- Understand and manage the analytical activities needed in support of the Drug Product development
- Support on the compilation of the dossier. Guarantee the source documentation and raw data
- Judge when and what external knowledge should be sourced-in (RA, clinical) during the development stages, and manage accordingly
- Work in close-cooperation with 'RA maintenance' function for defining and execution of submission strategy
- Understand and give Technical input and support to the Intellectual Property as well as Legal functions in the Business Unit
The ideal candidate
- You have a broad, in-depth knowledge (technically/scientifically) with regard to Drug Products. You also have thorough knowledge of product characterization, analytical method development, Drug Product development, scale -up/pilot activities, Drug Product manufacturing, stability studies, BE-studies and dossier content.
- You bring in existing knowledge in pharmaceutical Drug Products, ideally in generics, for optimal formulation development, thus reducing the risk on BE failure and obtaining manufacturing efficiency. A seasoned experience in solid oral dosage forms (powders, granules and tablets) is a prerequisite.
- having at least 5 years of experience in manufacturing and scale-up of formulation development of solid oral dosage forms, preferably in the generic pharmaceutical industry
- having experience in taking products from scratch to registration and experience of bringing generics to the market
- having extensive experience in collaborations with third parties
- followed a wide range of management and professional training
- preferably, having experience in project management
What you can expect
- Permanent contract
- Salary up to 95.000€
- Vibrant and international working environment
- 36,5 days of holiday
- Great pension scheme
Are you ready for a new challenge as Drug Development Manager at an international organisation with plenty of room for own initiative and development? Then get in touch with Gaia Brouwers for more information or to apply directly: 020 530 5888 / G.brouwers [@] progressiverecruitment.com.