Director, Quality Analytical Technical Lead, Small Molecule

Scorpion Therapeutics; United States; On-site; USD 180,000 - 250,000; Full time

Job summary

Scorpion Therapeutics seeks an Analytical Technical Lead at Director level to own analytical lifecycle management for commercial small molecules across major markets.

You will oversee strategies for drug substance, drug product and raw materials, lead OOS/OOT investigations, and ensure control strategies match product risk and regulatory standards, while coordinating regulatory submissions and post-approval changes.

Qualifications

• Bachelor's degree with 10+ years in biopharmaceuticals and GMP QC/analytical sciences.
• Master's degree with 7+ years in biopharma analytics or related field.
• Doctorate with 5+ years in biopharmaceutical analytics and GMP environments.

Responsibilities

• Serve as the primary technical contact for analytical lifecycle management across drug substances, products and raw materials.
• Lead investigations into OOS/OOT, deviations and method performance.
• Ensure analytical control strategies align with product risk and regulatory expectations.

Skills

HPLC

UPLC

GC

Analytical method validation

Data integrity

Stakeholder management

Technical writing

Education

Bachelor's degree in a relevant field

Master's degree in a related field

Doctorate in a related field

Job description

Role:

The Analytical Technical Lead (ATL) at Director level is the global owner for analytical lifecycle management of assigned commercial small molecule products across major markets, supporting post-approval maintenance and expansion.

Responsibilities:

serve as the primary technical contact, oversee analytical strategies for drug substance, drug product, and raw materials; lead investigations into OOS/OOT, deviations, and method performance; ensure analytical control strategies align with product risk profiles; manage regulatory submissions and post-approval changes; govern external QC networks and support audits and inspections; influence lab capacity and capability planning.

Qualifications:

Bachelor's degree with 10+ years, Master's with 7+ years, or Doctorate with 5+ years in biopharmaceuticals, with extensive GMP QC and analytical sciences experience.

Skills include:

expertise in small molecule methods (HPLC, UPLC, GC), validation, stability, and data integrity, along with strong stakeholder management and technical writing.

High-value specifics:

focus on small molecule lifecycle management, global regulatory support, GMP compliance, and analytical method lifecycle ownership.

Work setup:

involves up to 20% travel; location specifics not detailed.