Senior Scientist, Regulatory CMC Biologics

MSD • 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.

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.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Senior