Remote Senior AD&QC Leader, Oligo Analytics & Compliance

Scorpion Therapeutics; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Quality Control Lead to oversee analytical development and QC activities for late-stage oligonucleotide programs, supporting process validation, commercial readiness, and regulatory submissions.

In this role, you will manage AD&QC with CDMOs, develop analytical methods and specs, and author regulatory documents (IND/IMPD/NDA/MAA) while ensuring cGMP compliance across global operations. Periodic travel to Boston may be required.

Qualifications

• PhD in Organic/Analytical Chemistry or related field.
• Minimum 6 years of AD&QC experience within biotech/pharma.
• Hands-on experience with oligonucleotide QC and regulatory filings.

Responsibilities

• Manage AD&QC activities with CDMOs across programs.
• Develop and maintain analytical methods and specifications throughout product lifecycle.
• Prepare and review regulatory documents (IND, IMPD, NDA, MAA).
• Support GMP manufacturing readiness and inspections.
• Collaborate with R&D, QA, Regulatory, and Manufacturing to ensure quality and compliance.

Skills

AD&QC experience

Oligonucleotide QC

Regulatory filings experience

cGMP regulations knowledge

Education

PhD in Organic/Analytical Chemistry or related field

Job description

Scorpion Therapeutics is seeking a Senior Quality Control Lead to oversee analytical development and QC activities for late-stage oligonucleotide programs, supporting process validation, commercial readiness, and regulatory submissions.

In this role, you will manage AD&QC with CDMOs, develop analytical methods and specs, and author regulatory documents (IND/IMPD/NDA/MAA) while ensuring cGMP compliance across global operations. Periodic travel to Boston may be required.