Associate Director, Quality Control

Scorpion Therapeutics; San Francisco (CA); Hybrid; USD 163,000 - 228,000; Full time

Benefits offered by this job

Health Welfar Plans

Commuter benefits

401K match

Lunch in office

Job summary

Scorpion Therapeutics seeks an Associate Director of Technical Operations Quality Control to lead QC strategy and execution across our programs. The role collaborates with Analytical Development, QC, and external partners to ensure phase-appropriate control strategies and timely deliverables.

You will drive harmonization of QC methods, monitor risks, and guide QA with tuot capabilities for audits and regulatory submissions. Hybrid work in SF HQ with cross-functional leadership is expected.

Qualifications

• BA/BS in Biochemistry, Chemistry, Biology, Virology, Chemical Engineering, or related field (preferred).
• Technical expertise in analytical methods for biologics release/stability (e.g., mAbs, recombinant proteins).
• Strong knowledge of cGMP, ICH, FDA, and EMA; QC and/or assay development background.
• Experience with analytical method optimization, qualification, validation, transfer, implementation, and lifecycle management.
• Experience overseeing external partners (CDMOs/CTLs) in an outsourced model.
• Experience supporting CMC regulatory submissions, health authority responses, audit/inspection readiness.
• Strong communication; ability to assess risk, prioritize across programs, and execute in a matrixed environment.

Responsibilities

• Translate and implement QC strategy for assigned programs and external testing networks aligned with QC objectives.
• Lead QC activities across the product lifecycle (Phase 1 through commercial) for multiple programs.
• Develop/refine QC strategies with Analytical Development and QC leadership.
• Drive harmonization of QC methods/specifications across programs and partners.
• Identify/escalate QC performance, supply, regulatory, and compliance risks and develop mitigation plans.
• Represent QC on CMC/program teams and readiness for key CMC milestones.
• Provide leadership and coaching; may mentor QC colleagues and external partners.
• Oversee QC operations for timely, compliant release/stability testing (internal and outsourced).
• Oversee GMP documentation review (analytical data, batch records, CoAs); manage deviations, CAPAs with QA.
• Manage CTL/CDMO performance (governance, metrics, issue resolution).
• Oversee method lifecycle (qualification/transfer/validation/implementation/optimization/monitoring).
• Oversee reference standards and critical QC reagents.
• Support regulatory filings/health authority responses and audits.

Skills

Analytical method development

cGMP compliance

Project management

External partner management

Technical communication

Education

BA/BS in Biochemistry or related

Tools

HPLC/UPLC

LC-MS

Job description

Associate Director, Technical Operations Quality Control

What You’ll Do

• Translate and implement QC strategy for assigned programs and external testing networks (CDMOs/CTLs) aligned with QC/Quality/Technical Operations objectives.
• Lead QC activities across the product lifecycle (Phase 1 through commercial) for multiple programs, ensuring phase-appropriate control strategies and timely analytical deliverables.
• Develop/refine QC strategies (methods, specifications, testing approaches, and external execution models) with Analytical Development and QC leadership.
• Drive harmonization of QC methods/specifications/practices/documentation across programs and partners.
• Identify/escalate QC performance, supply, regulatory, and compliance risks; develop mitigation plans.
• Represent QC on CMC/program teams; align QC deliverables and readiness for key CMC milestones.
• Provide leadership/coaching; may manage/mentor QC colleagues and external partners.
• Oversee QC operations for timely, compliant release/stability testing (internal and outsourced).
• Oversee GMP documentation review (analytical data, batch records, CoAs); manage deviations, OOS/OOT, change controls, investigations, CAPAs with QA.
• Manage CTL/CDMO performance (governance, metrics, issue resolution).
• Oversee method lifecycle (qualification/transfer/validation/implementation/optimization/ongoing monitoring).
• Oversee reference standards and critical QC reagents.
• Support regulatory filings/health authority responses and serve as QC SME for audits/technical visits.
• Drive continuous improvement across QC processes and external network performance.

Who You Are and What You Bring

• BA/BS (12+ yrs), MA/MS/MBA (10+ yrs), or PhD (8+ yrs) in Biochemistry, Chemistry, Biology, Virology, Chemical Engineering, or related field (preferred).
• Technical expertise in analytical methods for biologics release/stability (e.g., mAbs, recombinant proteins).
• Strong knowledge of cGMP, ICH, FDA, and EMA; QC and/or assay development background.
• Experience with analytical method optimization, qualification, validation, transfer, implementation, and lifecycle management.
• Experience overseeing external partners (CDMOs/CTLs) in an outsourced model.
• Experience supporting CMC regulatory submissions, health authority responses, audit/inspection readiness.
• Strong communication; ability to assess risk, prioritize across programs, and execute in a matrixed environment.

Location

San Francisco headquarters; 3 days/week in office.

Compensation/Benefits

• Expected salary range: $162,500–$227,500/year; includes compensation, bonus and equity plus benefits
• health/welfare plans
• non-accrual PTO
• holiday shutdown
• commuter benefits
• 401K match
• lunch in office