Senior Raw Materials Consultant

Job Title:

Senior Raw Materials Consultant

Job Description

The Senior Raw Materials Consultant leads a strategic initiative to enhance and optimize the global Raw Materials Program for commercial GMP manufacturing operations. This role evaluates and improves raw material qualification processes, strengthens quality systems and documentation, and ensures alignment with regulatory expectations across the full product lifecycle. The consultant serves as a subject matter expert for raw materials and consumables, providing technical leadership, driving cross-functional collaboration, and delivering high-impact improvements with minimal oversight.

Responsibilities

+ Lead and support the completion of a strategic initiative focused on improving and enhancing the global Raw Materials Program.

+ Evaluate existing raw material qualification processes and identify opportunities for procedural and operational improvements.

+ Ensure raw material quality systems align with commercial manufacturing and regulatory requirements across the product lifecycle.

+ Revise and improve existing Raw Materials Standard Operating Procedures (SOPs) to strengthen quality and compliance.

+ Author and implement new SOPs supporting raw material lifecycle management and qualification activities.

+ Develop associated SOP Forms (SOPFORMs) and supporting documentation to standardize raw material processes.

+ Author, revise, and review specifications, procedural documents, quality records, and other controlled quality system documentation.

+ Ensure all documentation complies with GMP, quality system standards, and data integrity requirements.

+ Serve as the subject matter expert for raw material and consumable qualification activities throughout the product lifecycle.

+ Support and refine qualification strategies for raw materials utilized in commercial manufacturing operations.

+ Assess existing qualification programs and provide recommendations to improve efficiency, compliance, and risk mitigation.

+ Establish and refine appropriate controls for material qualification, lifecycle management, and ongoing monitoring.

+ Provide expertise in material release and disposition processes supporting commercial manufacturing.

+ Support investigations, assessments, and quality decisions associated with raw materials and consumables.

+ Collaborate closely with Quality Control, Manufacturing, and Supply Chain teams to ensure compliant material management practices.

+ Provide technical guidance on solid and liquid raw material sampling programs.

+ Review and improve raw material testing strategies and programs to optimize quality and compliance.

+ Identify opportunities to reduce testing while maintaining regulatory compliance, product quality, and patient safety.

+ Support risk-based approaches to raw material testing and qualification, incorporating science- and risk-driven methodologies.

+ Partner with Quality Control, Quality Assurance, Manufacturing, Supply Chain, Regulatory, and Technical Operations teams on raw material initiatives.

+ Provide technical leadership and recommendations on raw material quality-related projects and continuous improvement efforts.

+ Support project timelines and drive deliverables to completion with minimal oversight, ensuring milestones are met and outcomes are achieved.

Essential Skills

+ Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Biochemistry, Microbiology, Chemical Engineering, or a related scientific discipline.

+ Minimum of 10 years of Quality Control Raw Materials experience within the pharmaceutical, biotechnology, biologics, or broader life sciences industry.

+ Extensive experience supporting commercial GMP manufacturing operations and associated quality systems.

+ Demonstrated expertise in raw material and consumables qualification programs across the product lifecycle.

+ Strong understanding of commercialization and product lifecycle management as it relates to raw material controls and qualification.

+ Significant experience with material release and disposition processes in a GMP environment.

+ Proven experience authoring, editing, and reviewing GMP quality documents, including SOPs, protocols, and…