Senior Scientist, Regulatory CMC Biologics

Merck•Boston, MA

1d•Hybrid

About The Position

Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological projects. Be accountable for the delivery of all regulatory milestones through product development and / or post approval life cycle. Ensure development of robust CMC regulatory strategies for assigned projects. Be accountable for the execution of global product regulatory strategy(ies) by robust assessment of global regulatory CMC requirements and identification of potential risks. Manage execution of CMC documentation including IND/IMPD, original BLA/MAA, or Post approval / variations, agency background packages and responses to health authority questions per established business processes and systems. Identify, communicate and escalate potential regulatory issues to Global Regulatory and Clinical Safety CMC management, as needed. Conduct all activities with an unwavering focus on compliance.

Requirements

B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.
5 years of Regulatory CMC related experience, relevant experience including biological or vaccine drug substance/drug product development research, or manufacturing, testing and/or related field.
Business Processes
CMC Documentation
CMC Strategy
Detail-Oriented
Document Coordination
Drug Product Development
Interpersonal Relationships
Pharmaceutical Products
Regulatory CMC
Regulatory Communications
Regulatory Compliance
Regulatory Interpretation
Regulatory Project Management
Regulatory Strategy Development
Writing Technical Documents

Nice To Haves

Experience in biologics Regulatory CMC preferred.
CMC Biologics

Responsibilities

Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological projects.
Be accountable for the delivery of all regulatory milestones through product development and / or post approval life cycle.
Ensure development of robust CMC regulatory strategies for assigned projects.
Be accountable for the execution of global product regulatory strategy(ies) by robust assessment of global regulatory CMC requirements and identification of potential risks.
Manage execution of CMC documentation including IND/IMPD, original BLA/MAA, or Post approval / variations, agency background packages and responses to health authority questions per established business processes and systems.
Identify, communicate and escalate potential regulatory issues to Global Regulatory and Clinical Safety CMC management, as needed.
Conduct all activities with an unwavering focus on compliance.