Manager, Analytical Chemistry
About The Position
The Manager, Analytical QC is responsible for managing the activities of the quality control technical service to ensure the quality and compliance of laboratory operations for pharmaceutical products. This includes managing testing activities, method development, method validation, compendial/non-compendial method verification, and method transfer. Key responsibilities also involve collaborating with cross-functional teams, ensuring regulatory compliance (cGMP), and contributing to strategic planning and project delivery for the commercial market. The role manages the Laboratory Technical Service group, ensuring testing attributes for method validation, verification, and transfer are performed according to current ICH guidance. The manager oversees the day-to-day operations of Analytical QC activities, including project work assignment, and maintains knowledge of the potential impact of Analytical QC activities on cross-functional teams, communicating this information effectively and in a timely manner. Responsibilities include reviewing new source DMFs and evaluating method validations and methods prior to validation. The manager enforces laboratory GMP systems, ensuring they are adequate, sustainable, and followed, and maintains compliance with the USP. This involves formally monitoring and evaluating proposed changes to USP general chapters and monographs, and performing/coordinating method validation/verification as necessary. The role also includes leading the periodic review of current commercial methods to ensure supporting validation documents meet current standards and are robust for continued use. Reviewing method validation reports, specifications, and other documents for supplement submission, and providing input on department headcount, employee development, promotions, and salary increases are also key aspects of the position.
Requirements
- Must possess in-depth knowledge of method development, method validation, method verification and analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hyphenated) and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC, water content by TGA, identification by XRPD, and other techniques).
- Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis.
- Must understand and apply cGMP requirements applicable to quality control laboratory.
- Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner and report actions to the laboratory management in a timely manner.
- Must be able to identify trends in analytical data.
- Must have at least a bachelor’s degree in pharmacy or chemistry or pharmacology.
- Must have 12 months of experience in the position or in a related position.
Responsibilities
- Managing the activities of the quality control technical service to ensure the quality and compliance of Laboratory operation for pharmaceutical products.
- Managing testing activities, method development, method validation, compendial/non compendial method verification and method transfer.
- Collaborating with cross functional teams.
- Ensuring regulatory compliance (cGMP).
- Contributing to strategic planning and project delivery for commercial market.
- Manage the Laboratory Technical Service group responsible for ensuring the testing attributes for method validation, method verification and method transfer perform as per the current ICH guidance.
- Manage the day-to-day operations of the Analytical QC activities including work assignment of the projects.
- Maintain knowledge of the potential impact of Analytical QC activities in cross functional team and effectively communicate this information to the appropriate personnel in a timely manner.
- Review new source DMF and evaluate method validations and methods prior to their being validated.
- Manage/Enforce laboratory GMP systems and ensure that they are adequate, sustainable and are being followed.
- Maintain compliance with the USP.
- Formally monitor and evaluate proposed changes to the USP general chapters and monographs, and perform/coordinate method validation/verification, as necessary, to maintain compliance with the USP.
- Lead the periodic review of current commercial methods to ensure that the supporting validation documents meet current standards and are “rugged” enough to support their continued use in the commercial laboratory.
- Review the method validation reports, specifications, and other documents required for supplement submission.
- Provide input on yearly department headcount, on employee development including promotion and salary increases recommendations.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
