Project Manager - Drug Product Development

My client, a pioneer in the field of Pharmaceuticals and Biotechnolgy is looking to appoint a Project Manager - Drug Product. You will contribute your expertise in leading and manage all project activities linked to the development of oral solid dosage forms, support & coach team members, participate in scientific teams and contribute to the overall Technical Research and Development strategies and goals. This is a long-term 2 year contract with a view to becoming permanent.

Main Accountabilities
. You will contribute your expertise into developing the growing pipeline of products, in the development of oral solid dosage forms (including poorly soluble compounds).. As member of scientific teams within the Technical R&D group you will ensure that high quality products are developed applying state of the art technologies, risk analysis and QbD methodologies.
. You will work in close collaboration with Analytical department, Research, Drug Metabolism and Pharmacokinetics and Modeling & Simulation on related biopharmaceutical aspects (PK/PD requirements, IVIVC, etc.), Quality Assurance, Regulatory, Drug Supply Management.. You will evolve in a global multidisciplinary network organization where facilitation, coaching, coordination, excellent project management and planning skills are key to achieve sustainable performance.
. You will ensure robust formulations and processes through optimization, scale-up and validation work and provision of the required documentation to allow worldwide registration.
. You will be responsible to implement QbD principles into development and support its consistent and systematic roll out for the unit projects portfolio.
. You will be representing pharmaceutical development in external collaborations, which results in a wide range of scientific and strategic tasks including the management of the development and GMP activities
. The development of new technologies and supervision of scientific projects are further options within the position.

Minimum requirements
. The ideal candidate will have a PhD in Science with focus on pharmaceutical sciences and technology (eg Pharmacy, Chemistry).
. Minimum 7 years of successful industry experience in the development of pharmaceutical formulations (ideally oral solid dosage forms, solid understanding of QbD and biopharmaceuticals).
. Interdisciplinary thinking and interest in collaboration with other functions.
. Excellent scientific leadership skills.
. Excellent knowledge of laboratory and/or technical tools (eg QbD, statistical software, PAT).
. Broad and profound understanding of development activities and processes in pharmaceutical sciences.( early phase and late phase development)
. Successfully demonstrated track record of creativity and problem solving in projects.
. Strong knowledge of relevant GLP, GMP regulations and policies.
. Strong presentation skills and scientific/technical writing skills.
. Excellent project management skills
. Excellent communication skills, organizational, planning and negotiation skills.
. Advanced coaching skills.
. We expect a candidate to communicate fluently in English. German and/or French desired.

Please send your CVs

Michael Bailey International is acting as an Employment Business in relation to this vacancy.