Senior Regulatory CMC Scientist for ADC Bioconjugates

Merck; West Point (PA); On-site; USD 117,000 - 184,000; Full time

Job summary

Merck seeks a Senior Scientist to lead regulatory chemistry, manufacturing, and control strategies for synthetic components of antibody-drug conjugates and bioconjugates. You will deliver regulatory milestones across development and post-approval while coordinating with cross-functional teams.

The role requires strong expertise in CMC regulatory submissions, analytical methods, and regulatory risk management.

Qualifications

• Bachelor's degree in Chemistry, Chemical Engineering, Biochemistry, or related science field.
• Minimum 5 years regulatory CMC or pharmaceutical development experience in small molecules or synthesized modalities.
• Experience in process chemistry, analytical development, manufacturing, quality, or technical operations.
• Expertise in regulatory CMC, chemistry, and analytical methods.
• Strong regulatory compliance, document coordination, and communication skills.
• Preferred: CMC regulatory submission support and health authority interaction experience.
• Preferred: Experience with drug-linkers, payloads, ADCs, peptides, or bioconjugate products.

Responsibilities

• Lead regulatory CMC strategy for synthetic moieties of assigned ADC and bioconjugate programs
• Develop and execute phase-appropriate global regulatory CMC strategies for drug components
• Manage CMC documentation for IND applications, BLAs, MAAs, and post-approval submissions
• Integrate synthetic-moiety regulatory strategy with targeting component and conjugation process
• Conduct regulatory risk assessments and manage change controls with compliance focus

Skills

Regulatory CMC

Pharmaceutical development

Process chemistry

Analytical development

Communication skills

Education

Bachelor's degree in Chemistry or related field

Job description

Merck seeks a Senior Scientist to lead regulatory chemistry, manufacturing, and control strategies for synthetic components of antibody-drug conjugates and bioconjugates. You will deliver regulatory milestones across development and post-approval while coordinating with cross-functional teams.

The role requires strong expertise in CMC regulatory submissions, analytical methods, and regulatory risk management.