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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