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