Associate Principal Scientist - Biologics Product Development Job

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

This position will join the Sterile Products & Analytical Development group at the Merck Biologics Bioprocess unit in Kenilworth, NJ and be responsible for developing formulations for therapeutic proteins in support of programs at various stages of development.

- Support both early and late stage development which will include screening and developing formulations, clinical manufacturing process, technology transfer to pilot plants and regulatory filing. - Provide oversight and to use innovative approaches to design robust formulations, high throughput screening and manufacturing processes suitable for sterile dosage forms. - Active management and coaching of scientists, participation on formulation development teams and interfacing with cross-functional areas to drive project milestones. - Strong communication skills, good interpersonal skills, ability to multi-task, publication track record and a strong desire to learn, contribute and collaborate. - Protein formulation development, biophysical characterization, scale-up and regulatory filing experience. - Provide technical/scientific leadership within department and serves as a department representative on cross-functional teams and professional affiliations. Prior experience in leading a group and technical teams is essential.

**Education:** - Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, Chemistry or a related field. Required: - Minimum of (4) years of Protein Formulation Development experience - Formulation and biophysical analysis of proteins - Design experiments - Clinical process development of drug products - Project Management - Regulatory document preparation and filing **Preferred:** - Preformulation of proteins - Formulation of antibody-drug conjugates - Drug delivery