Senior Manager, Reference Standards & Reagents

Position Summary:

We are seeking a Senior Manager, Reference Standards & Reagents to join an experienced, fast-paced, and collaborative CMC team. This role will report to the Associate Director or Director, Quality Control and will provide strategic and operational leadership for lifecycle management of reference standards and critical reagents supporting biologics development and commercial operations.

The successful candidate will partner cross-functionally with Analytical Sciences, Quality Assurance, Regulatory Affairs, Manufacturing, Supply Chain, and external CDMOs/CTLs to ensure compliant qualification, inventory management, distribution, lifecycle oversight of reference standards and critical reagents used in GMP testing, and the associated tracking and trending. This role will support late-stage development, regulatory submissions, commercial activities and inspection preparedness.

Responsibilities:

• Own and manage the lifecycle of reference standards and critical reagents, including primary, working, interim, in-house, compendial, and assay control/standards from receipt and qualification through issuance, requalification, and retirement.
• Review and assess analytical data associated with reference standard qualification, stability monitoring, trending, and assay performance.
• Author, review, and approve GMP documentation including SOPs, qualification/requalification protocols and reports, CoAs/CoCs, deviations, CAPAs, change controls, and technical reports.
• Establish and maintain strategies for qualification, characterization, bridging, and requalification of reference standards and critical reagents to support analytical testing and product release.
• Ensure uninterrupted supply, inventory control, storage, labeling, distribution, and tracking of qualified reference standards and critical reagents for GMP operations.
• Define and oversee appropriate storage, handling, shipping, and environmental monitoring requirements, including management of temperature excursions and investigations.
• Collaborate with Analytical Development, QC, and external laboratories to support method qualification, validation, comparability assessments, and commercial specification setting activities.
• Maintain accurate and inspection-ready records within electronic systems.
• Support investigations related to deviations, OOS/OOT results, atypical trends, and risk assessments associated with reference standards and critical reagents.
• Partner with Regulatory Affairs to support regulatory filings, responses to health authority questions, and preparation of analytical sections related to reference standards and assay controls.
• Support internal audits, external inspections, and health authority inspections by ensuring inspection readiness of documentation and systems.
• Manage activities at CDMOs and contract testing laboratories related to reference standard qualification, inventory management, and analytical support.
• Drive continuous improvement initiatives to enhance operational efficiency, compliance, scalability, and business continuity for reference standard and reagent management processes.

Qualifications:

• PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with 3+ years of experience in biologics analytical development, quality control, or GMP laboratory operations, OR
• MS with 6+ years of relevant industry experience, OR BS with 8+ years of relevant industry experience.
• Strong knowledge of biologics Quality Control and industry best practices for reference standards, critical reagents, analytical controls, and stability programs.
• In-depth understanding and application of cGMP principles, data integrity requirements, and regulatory expectations in the US and internationally.
• Experience managing reference standard qualification and lifecycle activities for biologics in clinical and/or commercial environments.
• Experience supporting analytical methods across multiple technologies including chromatography, bioassays, and spectroscopy techniques.
• Experience authoring and reviewing GMP documentation including protocols, reports, SOPs, deviations, investigations, CAPAs, and regulatory filings.
• Experience working with CDMOs and contract testing laboratories in a GMP environment.
• Strong technical, organizational, and problem-solving skills with the ability to independently drive complex projects and develop innovative solutions.
• Excellent verbal and written communication skills and demonstrated ability to work effectively in a team-oriented environment.