Senior Scientist, Raw Materials

Role Summary

Role: Senior Scientist, Raw Materials. You will oversee the end-to-end lifecycle of GMP raw materials and provide strategic leadership for Clinical Biologics QC. You will coordinate sampling, testing, release, storage, and qualification; maintain material specifications, CoAs, and supplier communications; and support audits, regulatory filings, and cross-functional initiatives.

Responsibilities

• Manage the end-to-end lifecycle of GMP raw materials, including receipt, quarantine, sampling, testing coordination, release, storage, requalification, and expiry/disposal.
• Ensure uninterrupted availability of raw materials to support manufacturing and laboratory testing through proactive inventory planning and risk management.
• Coordinate GMP sampling and testing activities for raw materials (e.g., chemicals, excipients, buffers, solvents, reagents), including internal QC and external laboratories.
• Review and maintain raw material specifications, Certificates of Analysis (CoAs), quality agreements, and supplier change notifications; support supplier and material qualification and requalification.
• Oversee storage, labeling, segregation, and status control of materials under appropriate environmental conditions; manage excursions and related investigations.
• Maintain accurate raw material records in electronic systems (e.g., LIMS, ERP, EDMS); perform inventory reconciliations, cycle counts, and data trending.
• Serve as a key point of contact for externally tested materials, coordinating internal stakeholders and external laboratories to ensure timely release.
• Review and manage deviations, OOS/OOT results, risk assessments, and CAPAs.
• Ensure inspection readiness and support internal and external audits.
• Collaborate cross-functionally with Quality Control, Analytical Development, Regulatory Affairs, Quality Assurance, and Supply Chain to support method lifecycle, regulatory filings, and health authority inquiries.
• Author, review, and maintain GMP documentation, including protocols, reports, SOPs, deviations, change controls, CAPAs, and study closeout documentation.
• Collaborate cross-functionally with QC, CMC, Regulatory Affairs, Manufacturing, and Supply Chain to support raw material commitments, filings, and health authority responses.

Qualifications

• Experience with Biologics Quality Control with knowledge of industry best practices and trends for raw materials.
• In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.
• Ability to develop and improve complex concepts, techniques, standards and new applications based on quality principles and theories.
• Ability to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovation.
• Ability to exercise judgment and independently determine and take appropriate action where precedent may not exist.
• Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions.
• Demonstrated an ability to develop a vision for Quality Control functions and have shaped the capabilities of the function to fulfill that vision.
• Demonstrated the ability to influence process and outcomes across functions.
• 8+ Years experience with BS in Chemistry, Biochemistry or related field OR
• 6+ Years with MS in Chemistry, Biochemistry or related field OR
• 2+ Years with PhD in Chemistry, Biochemistry or related field
• Deep knowledge and experience in Biologics quality control.
• Stays ahead of shifting trends in industry.
• Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
• Strong organizational and planning skills.
• Excellent verbal and written communication skills and collaborative interpersonal skills.