Regulatory CMC Lead for ADC Drug-Linkers

Merck; North Wales (Montgomery County); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

Hybrid work model

Job summary

Merck seeks an Associate Principal Scientist Regulatory CMC - Biologics to lead the regulatory CMC program for drug-linkers in ADCs and bio-conjugates, delivering milestones across development and post-approval lifecycle in a cross-functional setting.

The ideal candidate has 10+ years in Regulatory CMC or related pharmaceutical development, with proven leadership and excellent cross-functional collaboration for global submissions, including IND/IMPD, BLA/MAA, and post-approval changes.

Qualifications

• At least 10 years of Regulatory CMC or related pharma development experience (5 with advanced degree).
• Proven ability to review detailed scientific information and support conclusions with data.
• Strong oral and written communication, in multicultural settings.
• Flexibility to adapt to changing priorities or unexpected events.
• Demonstrated leadership, project management, and negotiation skills.
• Ability to generate innovative regulatory solutions and engage stakeholders.

Responsibilities

• Lead Regulatory CMC for drug-linkers in ADCs and bio-conjugates across development and lifecycle.
• Develop phase-appropriate global CMC strategies for synthetic moieties and payloads.
• Assess global CMC requirements and identify risks for regulatory milestones.
• Integrate regulatory strategies with targeting components and conjugation processes.
• Prepare and execute CMC documentation for IND/IMPD, BLA/MAA, and post-approval changes.
• Manage change controls and filing strategies while ensuring compliance.
• Collaborate with cross-functional teams to ensure submission quality.
• Escalate issues to CMC leadership as needed.

Skills

Regulatory CMC

ADC

Biologics

Drug-linker

Communication

Leadership

Global regulatory

Education

B.S. in science/engineering/related field

Tools

eCTD

Job description

Merck seeks an Associate Principal Scientist Regulatory CMC - Biologics to lead the regulatory CMC program for drug-linkers in ADCs and bio-conjugates, delivering milestones across development and post-approval lifecycle in a cross-functional setting.

The ideal candidate has 10+ years in Regulatory CMC or related pharmaceutical development, with proven leadership and excellent cross-functional collaboration for global submissions, including IND/IMPD, BLA/MAA, and post-approval changes.