Manager, Analytical Chemistry

Responsibilities

• Manage the activities of the quality control technical service to ensure the quality and compliance of Laboratory operation for pharmaceutical products.
• Manage testing activities, method development, method validation, compendial/non compendial method verification and method transfer.
• Collaborate with cross-functional teams to ensure regulatory compliance (cGMP).
• Contribute 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. For all Amneal materials/products, 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.

Requirements

• 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).
• Able to follow compendial (USP/EP/BP/JP) procedures for analysis.
• Understand and apply cGMP requirements applicable to quality control laboratory.
• Able 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.
• Able to identify trends in analytical data.

Qualifications

• At least a bachelor’s degree in pharmacy or chemistry or pharmacology.
• At least 12 months of experience in the position or in a related position.

Benefits

Equal Opportunity Employer.

Salary: $129K - $135K per annum.

Hours: 40 hrs./wk. 8:30am – 5:30pm

Location: Piscataway and Branchburg, NJ

Ref # 12519