Senior 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 - Provide senior technical leadership for drug substance development and characterization teams including: - Lead characterization of downstream drug substance manufacturing processes including the design, execution, and interpretation of lab-scale, pilot scale and manufacturing scale elements of technical program to ensure processes are suitable for PPQ, licensure, and commercial manufacturing - Lead definition of process control strategy - Lead development of optimized post-launch manufacturing process - Influence establishment of drug substance specifications - Influence CMC regulatory strategy - Drive phase-appropriate process risk assessments - Manage technical programs including establishing and delivering on project timelines and milestones - Provide global support for commercial products (e.g. technical support, trouble shooting, deviation resolution, change control) - Author, review and edit technical documents to support regulatory filings including technical reports, risk assessments, and CTD sections - Oversee technical activities at third party organizations (CMOs, CROs) - Participate in regulatory inspections as the protein purification subject matter expert - Identify new technologies and work 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 12 years relevant experience in leading and managing biotechnological development projects - Recognized scientific leader in downstream bioprocess development - Strong track record of excellence in downstream process development, and development of commercial scale downstream processes - Experience with technology transfer across sites and geographies - 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 - Experience in manufacturing sciences preferred