Job Description:
Vendor management for analytical related activities for drug substance and drug product
• Oversees analytical method development, validation, and transfer activities by vendors
• Reviews method validation protocol, report, and as well as validation raw data
• Reviews release test data and generate CoA
Stability Coordinator for Drug Substance and Drug Product:
• Reviews stability data
• Generates stability result tables
• Files stability data and results tables
• Monitors stability due dates and coordinate data transfer from vendors
Reference Standard Coordinator:
• Oversee qualification, inventory and supply of standards and markers analytical support
• Files analytical methods, validation protocols, reports and any analytical related files
• Reviews analytical data and results to support analytical method transfer/validation at vendors
Shipping Coordinator:
• Coordinates and executes domestic and international CMC shipments
SharePoint filing:
• Support the CMC Team in the filing of documents
CMC/Regulatory:
• Drafts and reviews stability and analytical sections of IMPD/IND/NDA or related regulatory dossiers to support clinical programs
Skills & Experience:
• 7+ years of experience in analytical testing in biotech/pharma
• In depth knowledge of HPLC/UPLC, GC, KF, and other analytical techniques
• Hands on experience in carrying out stability studies for drug substance and drug product in QC environment
• Greater than 2+ years managing DS/DP stability, knowledge of ICH stability guidelines
• Detailed knowledge and understanding of current Good Manufacturing Practices (CGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems
• Knowledge of compendial (USP, EP, JP, etc.) requirements and standards for QC testing
• Ability to work independently as well as cross-functionally with teams across the organization
• Ability to effectively handle multiple projects simultaneously in a deadline driven environment
• Strong organizational skills and attention to detail
• Strong interpersonal and communication skills to collaborate effectively with internal and external business partners
Plus:
B.S in Chemistry or related field, M.S is preferred. Early Stage Bio
Remote: Associate Director Analytical Chemistry (232154)
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