Project Manager / Scientist USP Development PDC

The ideal candidate for People in Science should have:

• PhD in biological sciences, Biochemistry, Biochemical Engineering, or equivalent with a minimum of 3-5 years relevant industry experience in developing cell culture processes for late-stage and commercial manufacturing;
• Experience with tech transfer and characterization of late stage processes is preferred;
• Proven leadership with a minimum of 1-2 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 milestones 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.

• Leads a team of associates on the transfer in, scale-up, and characterization of cell culture processes for therapeutic proteins, specifically monoclonal antibodies for late stage clinical supply. Interfaces with early development, technical operations and manufacturing groups to facilitate a process transfer and utilizes advanced skills in QbD, DoE, PAT and data analysis, to drive characterization studies and CMC enabling documentation;
• Manages and will be held responsible for the quality level of potential outsourcing of cell culture related process development studies towards a contract manufacturing organization;
• Participates, as the cell culture Subject Matter Expert, in regulatory inspections and is experienced with the required GMP and regulatory guidelines;
• Identifies new technologies and works to implement these as new platforms with cross-functional early and late development teams.

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.