Principle Scientist

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.

Major Tasks - Responsible for development and characterization of late stage cell culture processes suitable for PPQ, licensure, and commercial manufacturing - Able to work independently and lead multidisciplinary teams - Responsible for managing outsourced process development and characterization activities at CMO/ TPO - Responsible for development, execution, and documentation of process characterization studies of cell culture processes using advanced skills in QbD, DOE, PAT, and data analysis - Responsible for development of optimized post-launch process - Responsible for tech transfer of cell culture processes for production of therapeutic proteins including drafting of technical reports and manufacturing documentation. Interfaces with early development, technical operations, and manufacturing departments to facilitate transfer of manufacturing processes - Responsible for cell culture related CMC enabling documentation - Project management and participation in cross-functional/global CMC teams - Manages and is responsible for the quality level of cell culture related process development studies and documentation - Participates in regulatory inspections as the cell culture subject matter expert - Identifies new technologies and works to implement new platforms with cross-functional early and late stage development teams - Responsible for global support to commercial products (e.g. technical support/trouble shooting)

Qualifications - PhD (or equivalent experience) in biological sciences, biochemistry, or biochemical engineering - Minimum of 8 years relevant experience in managing biotechnological development projects - Relevant cell culture experience preferred - Proven strong scientific, project, and people management skills - Strong communicator and ability to build bridges between groups and organizations. - Excellent analytical and technical skills - Demonstrated initiative, and innovative process-oriented thinking within a team environment - Knowledge of regulatory and quality guidelines - Experience with supporting regulatory filings for US and worldwide markets preferred - Experience in manufacturing sciences preferred