Associate Director, MS&T Raw Material Specialist

Scorpion Therapeutics; Gaithersburg (MD); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Comprehensive benefits

Bonus/equity

Job summary

Scorpion Therapeutics in Gaithersburg, MD seeks an Associate Director, MSAT Raw Material Specialist to develop strategies for raw material lifecycle management in biologics or mRNA manufacturing.

You will lead cross-functional initiatives, define material attributes linked to process robustness, and ensure GMP-compliant lifecycle management and regulatory readiness. The role offers a comprehensive benefits package and potential bonus/equity.

Qualifications

• 6+ years of industry experience with CMC for biologics or mRNA platforms.
• Experience with technology transfer and lifecycle management.
• GMP compliance knowledge and regulatory interactions.

Responsibilities

• Lead cross-functional initiatives and define critical material attributes.
• Conduct risk assessments and supplier evaluations.
• Manage post-approval changes and support regulatory submissions.

Skills

Raw material risk assessments

Material characterization

Control strategies

Regulatory expectations

Education

MS or PhD in Biochemical Engineering, Chemical Engineering, Pharmaceutical Sciences, or related fields

Job description

Role

Associate Director, MSAT Raw Material Specialist, responsible for developing and executing strategies for raw material lifecycle management in biologics or mRNA manufacturing.

Objectives

Ensuring product quality, manufacturability, and regulatory compliance through material science expertise.

Responsibilities

• Responsibilities encompass leading cross-functional initiatives, defining critical material attributes linked to process robustness, conducting risk assessments, supplier evaluations, managing post-approval changes, and supporting regulatory submissions.

Requirements

• MS or PhD in Biochemical Engineering, Chemical Engineering, Pharmaceutical Sciences, or related fields.
• 6+ years' industry experience with deep knowledge of CMC processes for biologics or mRNA platforms, including technology transfer, lifecycle management, and GMP compliance.

Preferred skills

• Expertise in raw material risk assessments, characterization, control strategies, and understanding of regulatory expectations.

High-Value

• Focus on biologics or mRNA modalities, GMP manufacturing, lifecycle management, post-approval changes, regulatory interactions, and raw material science.

Work setup

Based in Gaithersburg, MD, with a comprehensive benefits package, competitive salary range, and potential variable bonus/equity.