Sr. Manufacturing Compliance Specialist

Scorpion Therapeutics; Burlington (MA); On-site; USD 70,000 - 95,000; Full time

Job summary

Scorpion Therapeutics in Burlington, MA, is seeking a Manufacturing Compliance Specialist to ensure compliance in cell therapy operations. This role involves leading deviation investigations, managing quality systems, and technical support for manufacturing processes.

The ideal candidate will have a BA/BS in a scientific field, 3–6 years in biopharmaceutical manufacturing, and a solid understanding of cGMP regulations. Working conditions require onsite presence Monday to Friday, with occasional weekend work.

Qualifications

• 3–6 years of experience in biopharmaceutical manufacturing.
• Strong knowledge of cGMP and regulatory requirements.
• Excellent written and verbal communication skills.

Responsibilities

• Lead deviation investigations using structured root cause analysis.
• Ensure compliance with cGMP, data integrity, and internal quality systems.
• Drive project timelines and manage risks in cross-functional projects.

Skills

cGMP compliance

Cross-functional project leadership

Technical support for manufacturing processes

Quality Management Systems

Education

BA/BS in a scientific discipline

Tools

OpCenter

ERP

TrackWise

Veeva

Job description

Position Summary

The Manufacturing Compliance Specialist serves as the compliance subject matter expert within Manufacturing, ensuring cell therapy operations are executed in accordance with cGMP, regulatory requirements, and internal quality systems.

Key Responsibilities

Quality Management System

• Lead deviation investigations using structured root cause analysis
• Author and manage deviations, CAPAs, and Change Controls through closure
• Perform impact and risk assessments to support manufacturing changes
• Ensure compliance with cGMP, data integrity (ALCOA+), and internal quality systems
• Support regulatory inspection readiness and audit responses

Technical Expertise

• Provide technical support/troubleshooting for cell therapy manufacturing processes
• Author and revise manufacturing documentation (SOPs, batch records, job aids)
• Support manufacturing projects and process validation
• Review manufacturing operations to identify compliance and process improvement opportunities
• Maintain expertise in aseptic processing, cleanroom operations, and BSC practices

Project Leadership & Continuous Improvement

• Lead cross-functional projects to completion without direct authority
• Partner cross-functionally to resolve technical and compliance issues
• Drive project timelines, manage risks, and communicate status
• Support Lean/Continuous Improvement initiatives
• Support implementation/enhancements of manufacturing systems (EBR, MES, ERP, electronic QMS)

Basic Qualifications

• BA/BS in a scientific discipline (or equivalent experience)
• 3–6 years in biopharmaceutical manufacturing
• Familiarity with OpCenter, ERP, EBR, TrackWise, Veeva
• Knowledge of biopharmaceutical equipment/manufacturing systems
• Strong knowledge of cGMP and regulatory requirements
• Excellent written/verbal communication
• Demonstrated experience leading cross-functional projects

Preferred Qualifications

• Lean Six Sigma certification/experience
• Root Cause Analysis or GEMBA Problem Solving (certification/experience)
• HEPP experience; basic lab skills (mammalian cell culture)
• Cell therapy or aseptic manufacturing experience

Working Conditions

• Onsite Mon–Fri 8am–5pm; split ~50/50 between Burlington, MA and Cambridge, MA (eventually ~80/20 Burlington/Cambridge)
• May work one weekend day per quarter; evenings as required; rotating holiday on-call
• Ability to gown and enter manufacturing areas