Global Regulatory CMC Lead for ADC Bioconjugates

Merck; Rahway (NJ); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision

Hybrid work model

401(k)

Job summary

Merck is seeking an Associate Principal Scientist in Regulatory CMC for Synthetic Moieties of ADCs and Bioconjugates. The role develops global regulatory strategies, leads CMC documentation across IND/IMPD, BLA/MAA, and post-approval changes, and partners with cross-functional teams to meet regulatory milestones.

The primary location is USA - Pennsylvania - North Wales. Hybrid work arrangements are available with a comprehensive benefits package.

Qualifications

• Minimum B.S. in a science/engineering field; advanced degree preferred.
• 10+ years in Regulatory CMC or related pharmaceutical development.
• Experience with drug-linkers, ADCs, or bio-conjugates is desirable.

Responsibilities

• Lead Regulatory CMC activities for ADCs and bio-conjugates across global programs.
• Develop phase-appropriate global regulatory strategies for drug-linkers and moieties.
• Manage CMC documentation for IND/IMPD, BLA/MAA, and post-approval changes.
• Collaborate with cross-functional teams; ensure timely regulatory milestones.
• Oversee change controls and regulatory filing strategies; ensure compliance.

Skills

Regulatory CMC

ADC / Bioconjugates

Global regulatory strategy

IND/BLAs experience

Cross-functional leadership

Communications (oral/written)

Education

B.S. in science/engineering

Job description

Merck is seeking an Associate Principal Scientist in Regulatory CMC for Synthetic Moieties of ADCs and Bioconjugates. The role develops global regulatory strategies, leads CMC documentation across IND/IMPD, BLA/MAA, and post-approval changes, and partners with cross-functional teams to meet regulatory milestones.

The primary location is USA - Pennsylvania - North Wales. Hybrid work arrangements are available with a comprehensive benefits package.