Regulatory CMC Leader, ADCs & Bioconjugates

MSD; Northern (KY); Hybrid; USD 142,000 - 224,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ, United States, seeks an Associate Principal Scientist to lead Regulatory CMC for synthetic moieties of ADCs and other bio-conjugates.

You will guide cross-functional teams, design global regulatory strategies, and drive timely IND/IMPD and BLA submissions. The role requires a strong background in CMC, experience with drug-linkers, payloads, and conjugation chemistry, and excellent communication across multicultural teams.

Qualifications

• Experience in Regulatory CMC for small molecules or bio-conjugates.
• Strong ability to review scientific data and present clear regulatory arguments.
• Experience leading cross-functional teams and regulatory submissions.

Responsibilities

• Lead Regulatory CMC for synthetic moieties of ADCs and bio-conjugates.
• Develop phase-appropriate global CMC strategies for drug-linkers and payloads.
• Prepare and coordinate regulatory documents (IND/IMPD, BLA/MAA) and responses.
• Manage change controls and regulatory filing strategies with leadership.

Skills

Regulatory CMC

ADC

Regulatory Affairs

Project management

Communication

Education

B.S. in science or related field

Tools

eCTD

IND/IMPD

Job description

Merck & Co., Inc. in Rahway, NJ, United States, seeks an Associate Principal Scientist to lead Regulatory CMC for synthetic moieties of ADCs and other bio-conjugates.

You will guide cross-functional teams, design global regulatory strategies, and drive timely IND/IMPD and BLA submissions. The role requires a strong background in CMC, experience with drug-linkers, payloads, and conjugation chemistry, and excellent communication across multicultural teams.