Director Analytical Development

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

Job summary

Scorpion Therapeutics seeks an accomplished Director of Analytical Development (ADQC) to lead strategic and technical efforts for biologics programs from early development through commercialization. The role blends hands-on lab work with strategic oversight of analytical control strategies, methods, validation, transfer, and lifecycle management.

The position requires extensive experience in analytical development, regulatory submission support, and managing outsourcing relationships, with

Qualifications

• PhD preferred in Biochemistry, Biophysics, or related field.
• 8+ years in biopharma, including 4+ years in management within biologics analytical development.
• Expertise in analytical strategies, validation, transfer, and regulatory guidelines.
• Proven success supporting regulatory submissions and managing outsourcing.

Responsibilities

• Oversee analytical control strategies, method development, validation, transfer, lifecycle management, and analytical readiness for late-stage and commercial.
• Perform hands-on laboratory work and troubleshooting of methods.
• Manage reference standards and critical reagent programs.
• Author regulatory CMC sections for submissions.
• Scale capabilities, oversee equipment qualification, and implement workflows.
• Collaborate with QC, QA, process development, manufacturing, regulatory affairs, and external partners to ensure compliance with cGMP, ICH, USP, and industry standards.
• Ensure inspection readiness and lead external analytical activities and partnerships.

Skills

A280

HPLC

CE

LC-MS

ELISA

Cell-based potency

Regulatory submissions

Outsourcing management

Education

PhD in Biochemistry, Biophysics, or related field

Job description

Role

Director of Analytical Development, Analytical Development and Quality Control (ADQC), leading strategic and technical efforts for biologics programs from early development through commercialization.

Responsibilities

• oversee analytical control strategies, method development, validation, transfer, lifecycle management, and ensure analytical readiness for late-stage and commercial phases


• perform hands-on laboratory work


• troubleshoot and optimize methods


• manage reference standard and critical reagent programs


• author regulatory CMC sections


• scale capabilities, oversee equipment qualification, and implement workflows


• Collaborate with QC, QA, process development, manufacturing, regulatory affairs, and external partners to ensure compliance with cGMP, ICH, USP, and industry standards


• ensure inspection readiness


• lead external analytical activities and manage external partnerships

Requirements

• PhD preferred in Biochemistry, Biophysics, or related field


• 8+ years in biopharma, including 4+ years in management within biologics analytical development


• expertise in A280, HPLC, CE, LC-MS, ELISA, cell-based potency


• strong understanding of analytical strategies, validation, transfer, and regulatory guidelines


• proven success supporting regulatory submissions and managing outsourcing

HighValue

biologics, late-stage development, BLA/MAA submissions, cGMP compliance, analytical method lifecycle, hands-on laboratory expertise.

WorkSetup

remote; travel not typical.