Regulatory CMC Scientist for ADCs & Bioconjugates — Hybrid

Scorpion Therapeutics; Rahway (NJ); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work setup

No travel required

Job summary

Scorpion Therapeutics in Rahway, NJ invites a Senior Scientist (R3) to lead Regulatory CMC activities for synthetic moieties of ADCs and bioconjugates, guiding product development through lifecycle.

You will develop global CMC strategies for drug-linkers, payloads, and peptides, manage regulatory docs (INDs, MAAs, post-approval), assess requirements, ensure compliance, and align with manufacturing and dossiers; hybrid work setup, travel not required.

Qualifications

• Regulatory CMC leadership for synthetic moieties in ADCs/bioconjugates.
• Global regulatory strategies across lifecycle.
• Experience with regulatory submissions and lifecycle management.

Responsibilities

• Develop and implement global regulatory CMC strategies for drug-linkers, payloads, peptides, and chemically synthesized components.
• Manage regulatory documentation including INDs, MAAs, and post-approval submissions.
• Assess global regulatory requirements, identify risks, and ensure compliance.
• Align regulatory strategies with manufacturing, conjugation processes, and product dossiers.

Skills

Regulatory CMC

Global regulatory strategy

IND/MAA submissions

GxP compliance

Cross-functional collaboration

Education

Bachelor's degree in Chemistry, Chemical Engineering, Biochemistry or related field

Job description

Scorpion Therapeutics in Rahway, NJ invites a Senior Scientist (R3) to lead Regulatory CMC activities for synthetic moieties of ADCs and bioconjugates, guiding product development through lifecycle.

You will develop global CMC strategies for drug-linkers, payloads, and peptides, manage regulatory docs (INDs, MAAs, post-approval), assess requirements, ensure compliance, and align with manufacturing and dossiers; hybrid work setup, travel not required.