Regulatory CMC Lead, Drug-Linkers & Bioconjugates

HireLifeScience; North Wales (Montgomery County); Hybrid; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) retirement plan

Paid holidays

Job summary

Merck & Co., Inc. in the United States is seeking a Senior Scientist (R3) Regulatory CMC to lead the regulatory chemistry aspects of ADC drug-linkers and Bioconjugates.

You will provide regulatory leadership within Regulatory and cross-functional teams to deliver milestones throughout development and lifecycle. The role requires 5+ years in regulatory CMC or related pharmaceutical development, with experience in drug-linkers, payloads, ADCs, and global submissions.

Qualifications

• Education: B.S. in a science, engineering, or related field.
• 5+ years of regulatory CMC or related pharmaceutical development experience.
• Experience with drug-linkers, ADCs, or bio-conjugates preferred.

Responsibilities

• Lead Regulatory CMC for drug-linkers in ADC programs and other bio-conjugates.
• Deliver regulatory milestones through development and lifecycle phases.
• Develop and execute phase-appropriate global Regulatory CMC strategies.
• Oversee regulatory submissions (ANDAs/INDs/BLAs) and health authority interactions.
• Manage change controls and filing strategies with regulatory compliance.
• Maintain unwavering focus on compliance across activities.

Skills

Regulatory CMC

ADC

Bioconjugation

Drug Development

eCTD

Process Chemistry

Regulatory Strategy

Documentation

Education

B.S. in science/engineering/related field

Advanced degree preferred

Job description

Merck & Co., Inc. in the United States is seeking a Senior Scientist (R3) Regulatory CMC to lead the regulatory chemistry aspects of ADC drug-linkers and Bioconjugates.

You will provide regulatory leadership within Regulatory and cross-functional teams to deliver milestones throughout development and lifecycle. The role requires 5+ years in regulatory CMC or related pharmaceutical development, with experience in drug-linkers, payloads, ADCs, and global submissions.