Associate Director, Biologics Separation Sciences & Methods

Scorpion Therapeutics

Lexington (MA)

On-site

USD 170,000 - 260,000

Full time

7 days ago

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Job summary

Scorpion Therapeutics is seeking a senior leader to head Separation Sciences within Biologics Analytical Development & Quality Control. You will guide method development, qualification, validation, and transfer for GMP release and stability testing of complex biologics.

Lead HPLC/UPLC and capillary electrophoresis programs, apply AQbD, and drive robust control strategies while mentoring a cross-functional team and partnering with PD, QA, and Regulatory for regulatory filings.

Qualifications

PhD/MS/BS in analytical development or related field, with extensive hands-on experience.
Experience in biologics analytical development (HPLC/UPLC, capillary electrophoresis).
Proven track record leading method development/qualification/validation/transfer for GMP release and stability testing.
Experience with monoclonal antibodies, bispecifics, ADCs, or other complex biologics.
Knowledge of AQbD, risk assessment, and regulatory expectations (ICH).
Experience supporting regulatory submissions and health authority inquiries.
Experience with Empower and JMP; electronic lab systems.
Advanced data analytics/digital tools/automation/AI approaches preferred.
Ability to lead and develop people while balancing depth and cross-functional work.

Responsibilities

Establish scientific/technical strategy for HPLC/UPLC and CE assays for biologics GMP release and stability testing.
Design/update separation methods using AQbD to ensure robust control strategies.
Set phase-appropriate system suitability and assay control strategies aligned with regulatory expectations.
Develop/implement/monitor/improve analytical platform methods and control strategies.
Provide SME for lifecycle management and late-stage biologics programs.