Senior Manager, Reference Standards & Reagents

Jobtailor; Deutschland; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

Jobtailor is seeking an experienced specialist to own the lifecycle of reference standards and critical reagents in a GMP environment. You will review stability data, author GMP documentation, and collaborate with Analytical Development, QC, and external labs to support method qualification and product release.

Key responsibilities include maintaining compliant records, coordinating with CDMOs, and driving improvements in processes for compliance and efficiency.

Qualifikationen

• PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with 3+ years in biologics analytical development.
• MS with 6+ years or BS with 8+ years in related industry.
• Strong knowledge of biologics QC and industry best practices for reference standards, critical reagents, analytical controls, and stability programs.
• In-depth understanding of cGMP, data integrity, and regulatory expectations in US and internationally.
• Experience managing reference standard qualification and lifecycle activities for biologics in clinical and/or commercial environments.
• Experience authoring and reviewing GMP documents, including protocols, reports, SOPs, deviations, investigations, CAPAs, and regulatory filings.

Aufgaben

• Own and manage the lifecycle of reference standards and critical reagents from receipt, qualification, through issuance, requalification, and retirement.
• Review analytical data for qualification, stability monitoring, trending, and assay performance.
• Author, review, and approve GMP documentation including SOPs, protocols, reports, CoAs/CoCs, deviations, CAPAs, and change controls.
• Establish strategies for qualification, characterization, bridging, and requalification of reference standards to support testing and release.
• Ensure supply, inventory control, storage, labeling, distribution, and tracking of standards and reagents.
• Define storage, handling, shipping, and environmental monitoring requirements, including temperature excursions and investigations.
• Collaborate with Analytical Development, QC, and external labs to support method qualification/validation and specification setting.
• Maintain accurate, inspection-ready records in electronic systems.
• Support investigations related to deviations, OOS/OOT, and risk assessments for standards and reagents.
• Partner with Regulatory Affairs on regulatory filings and analytical sections.
• Support internal audits and inspections by ensuring readiness of docs and systems.
• Manage activities at CDMOs and contract labs related to qualification and inventory management.
• Drive continuous improvement to enhance efficiency, compliance, scalability, and business continuity.

Kenntnisse

cGMP knowledge

Data integrity

Analytical development

Regulatory filings

Project management

Ausbildung

PhD in chemistry/biochemistry/pharmaceutical sciences

MS with 6+ years of experience

BS with 8+ years of experience

Tools

LIMS

Documentation software

Jobbeschreibung

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.

Requirements

• 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.