Senior Manager, Reference Standards – Reagents

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership and manage the entire lifecycle of reference standards and critical reagents, which includes primary, working, interim, in-house, compendial, and assay control/standards from the point of receipt and qualification through to issuance, requalification, and eventual retirement.

• Evaluate and analyze analytical data related to reference standard qualification, stability monitoring, trending, and assay performance.

• Draft, review, and authorize GMP documentation such as SOPs, qualification/requalification protocols and reports, CoAs/CoCs, deviations, CAPAs, change controls, and technical reports.

• Develop and uphold strategies for the qualification, characterization, bridging, and requalification of reference standards and critical reagents to facilitate analytical testing and product release.

• Guarantee a seamless supply chain, inventory management, storage, labeling, distribution, and tracking of qualified reference standards and critical reagents for GMP operations.

• Specify and supervise proper storage, handling, shipping, and environmental monitoring protocols, including the management of temperature excursions and associated investigations.

• Collaborate with Analytical Development, QC, and external laboratories to assist in method qualification, validation, comparability assessments, and the establishment of commercial specifications.

• Keep precise and inspection-ready records within electronic systems.

• Aid in investigations concerning deviations, OOS/OOT results, atypical trends, and risk assessments related to reference standards and critical reagents.

• Work alongside Regulatory Affairs to assist with regulatory filings, responses to inquiries from health authorities, and the compilation of analytical sections pertaining to reference standards and assay controls.

• Facilitate internal audits, external inspections, and health authority reviews by ensuring documentation and systems are ready for inspection.

• Oversee activities at CDMOs and contract testing laboratories concerning reference standard qualification, inventory management, and analytical support.

• Lead continuous improvement initiatives aimed at enhancing operational efficiency, compliance, scalability, and business continuity for the management processes of reference standards and reagents.

⛳️ Requirements

• PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with over 3 years of experience in biologics analytical development, quality control, or GMP laboratory operations, OR

• MS with more than 6 years of relevant industry experience, OR BS with over 8 years of relevant industry experience.

• Comprehensive knowledge of biologics Quality Control and industry best practices concerning reference standards, critical reagents, analytical controls, and stability programs.

• Profound understanding and application of cGMP principles, data integrity standards, and regulatory expectations both in the US and internationally.

• Proven experience in managing reference standard qualification and lifecycle activities for biologics in clinical and/or commercial settings.

• Background in supporting analytical methods across diverse technologies including chromatography, bioassays, and spectroscopy techniques.

• Experience in drafting and reviewing GMP documentation such as protocols, reports, SOPs, deviations, investigations, CAPAs, and regulatory submissions.

• Familiarity with working alongside CDMOs and contract testing laboratories in a GMP environment.

• Strong technical, organizational, and problem-solving capabilities with the ability to independently manage complex projects and formulate innovative solutions.

• Exceptional verbal and written communication skills, with a demonstrated ability to work efficiently in a team-oriented setting.

🏝️ Benefits

• Health insurance

• Dental insurance

• Vision insurance

• 401k match

• Flexible time off

• Paid holidays

• Annual performance incentive bonus

• New hire equity

• Ongoing performance-based equity