Senior Quality Control Analyst in Westwood, Massachusetts

Senior Quality Control Analyst

Are you a scientific professional with expertise in analytical chemistry, biochemistry, formulation development, and pharmaceutical product development? We are seeking a Senior Scientist to provide technical leadership in analytical testing, formulation development, method development, and process optimization. This role supports the development and analysis of pharmaceutical, biotechnology, and related products while ensuring compliance with regulatory, quality, and operational requirements. The ideal candidate combines expertise in chemistry, biochemistry, analytical science, formulation development, method validation, laboratory operations, and project leadership with strong problem-solving and communication skills.

Analytical Testing & Scientific Analysis

• Perform advanced analytical testing utilizing a variety of laboratory techniques and instrumentation.
• Analyze materials, products, biological samples, and devices.
• Conduct complex scientific investigations and testing activities.
• Follow approved Standard Operating Procedures (SOPs) and analytical methods.
• Deliver accurate, high-quality scientific results.

Method Development & Validation

• Develop, validate, optimize, and transfer analytical methods.
• Support routine and non-routine analytical testing requirements.
• Ensure analytical methods meet regulatory and quality standards.
• Maintain method documentation and technical records.
• Support technology transfer and laboratory implementation activities.

Typical Instrumentation

• HPLC (High Performance Liquid Chromatography)
• GC (Gas Chromatography)
• LC-MS
• FTIR
• ddPCR (Digital Droplet PCR)
• Other advanced analytical platforms

Formulation Development

• Design and develop robust formulations for:
• Small Molecule Products
• Biologics
• Early-Stage Clinical Products
• Support formulation optimization activities.
• Evaluate formulation performance and stability.
• Recommend formulation improvements based on analytical findings.
• Contribute to product development programs.

Process Development & Manufacturing Support

• Develop and optimize manufacturing processes for drug products.
• Support scale-up, process transfer, and production readiness activities.
• Interpret scientific and manufacturing data to drive process improvements.
• Collaborate with manufacturing teams to ensure successful process implementation.
• Support operational efficiency and product quality objectives.

Data Analysis & Scientific Interpretation

• Review, analyze, and interpret scientific data.
• Identify trends, patterns, and potential issues.
• Draw scientifically sound conclusions from analytical results.
• Prepare recommendations and present findings to stakeholders.
• Support evidence-based decision-making.

Technical Leadership

• Provide work direction, coaching, and scientific guidance to laboratory personnel.
• Serve as a subject matter expert in chemistry, biochemistry, and formulation development.
• Support staff training on:
• Analytical Techniques
• Laboratory Procedures
• Scientific Instrumentation
• SOP Compliance
• Promote technical excellence across the team.

Client & Stakeholder Support

• Serve as a technical advisor to:
• Clients
• Project Teams
• Laboratory Staff
• Management
• Provide scientific interpretation and recommendations.
• Present technical findings and project updates.
• Build strong collaborative relationships with internal and external stakeholders.

Project Management

• Participate in or lead scientific projects and programs.
• Support planning activities including:
• Project Objectives
• Timelines
• Resource Requirements
• Budgets
• Personnel Allocation
• Track project progress and communicate status effectively.
• Contribute to successful project execution.

Regulatory Compliance & Quality Assurance

• Ensure compliance with:
• GMP (Good Manufacturing Practices)
• GLP (Good Laboratory Practices)
• SOP Requirements
• Regulatory Guidelines
• Quality Standards
• Maintain accurate documentation and laboratory records.
• Support audits, inspections, and quality initiatives.
• Promote a culture of compliance and scientific integrity.

Continuous Improvement

• Identify opportunities to improve:
• Testing Processes
• Laboratory Efficiency
• Scientific Methodologies
• Product Development Activities
• Participate in cross-functional improvement initiatives.
• S…