Director DSP Development PDC

The ideal candidate for People in Science should have:

• Ph.D in biological sciences, Biochemistry, Biochemical Engineering, or equivalent and at least 5 years relevant industry experience in developing protein purification processes for late-stage and commercial manufacturing. Must have technical expertise in protein chemistry and glycoprotein product characterization. Proven leadership with a minimum of 3-5 years of supervisory experience. Detailed knowledge of relevant regulatory and quality guidelines and GMP requirements, and experience with BLA/MAA submissions;
• Clear and concise communication skills, both written and spoken, manages resources to accommodate multiple products in late clinical development and commercial characterization, demonstrates flexibility to accommodate change in directions or timelines. Fosters collaborations across multiple groups for efficient utilization of resources in solving technically challenging problems. Must have strong and effective organizational, people management and interpersonal skills. Excellent analytical and technical skills are required along with demonstrated initiative and innovative thinking within a team environment;
• Percentage in service 100.

Lead a process sciences organization and serve as the subject matter expert in the development and characterization of downstream manufacturing processes for late stage clinical supply and commercialization of therapeutic proteins, monoclonal antibodies. Responsible for establishing Process Characterization methods (QbD / DOE), effective scale down models enabling transfer in and translation of lab scale processes to clinical and commercial scale manufacturing, successful process qualification and required regulatory documents enabling BLA/MAA submissions. Continually evaluates and develops new purification and protein chemistry technologies for incorporation into high throughput lab and manufacturing processes, equipment and operations

MSD is working to help the world be well. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. MSD is the name of Merck outside the US and Canada. MSD has a workforce of over 6.000 in the Netherlands at five different
sites. MSD is the largest pharmaceutical company in the Netherlands. It has large production facilities for Human Health and Animal Health in Oss, Haarlem and Boxmeer and R&D facilities in Boxmeer and Oss. The MSD Development Center in Oss (DCO) supports MSD’s need for product development activities, particularly for the emerging markets. The DCO is also involved in Product Value Enhancement and it supports MSD’s early phase clinical research in multiple therapeutic areas.

The Center of Excellence Biotech Technical Operations gives technical support, process support - troubleshooting and continuous improvement - to the local Biotech upstream and downstream Integrated Process Teams (operations), is involved by process fit / introduction of new processes in the production facilities and cooperates with other technical groups in the global network.