Associate Director, Analytical Development & Quality Control

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

Role

Role: Senior Quality Control Lead overseeing analytical development and QC activities for late-stage oligonucleotide programs, supporting process validation, commercial readiness, and regulatory submissions.

Responsibilities

Responsibilities: manage AD&QC activities with CDMOs, develop and maintain analytical methods and specifications across product lifecycle, author/review regulatory documents (IND, IMPD, NDA, MAA), and support GMP manufacturing readiness. Acts as SME during inspections and audits, ensuring compliance with global regulatory standards (ICH, FDA, EMA, cGMP). Collaborates across R&D, QA, Regulatory, and manufacturing teams to ensure quality and compliance.

Requirements

Requirements: Ph.D. in Organic/Analytical Chemistry or related field, min. 6 years in AD&QC within biotech/pharma, extensive experience with oligonucleotide QC, regulatory filings, and cGMP regulations.

Preferred

Preferred: knowledge of PMO/PTMO, experience with late-stage, commercial oligo manufacturing, and regulatory submission expertise.

HighValue

HighValue: oligonucleotide therapeutics (DMD, DM1), late-stage/production, regulatory documentation, GMP compliance, cross-functional coordination.

Location

Location: Remote US, preference for New England candidates with periodic travel to Boston.