Job Description

The individual will be responsible for all aspects of AAV based CMC activities. 
The Individual will collaborate with QA, Regulatory, SMEs, and CMOs for CMC formulation development, method development, process development, storage/inventory management, logistics etc.
RESPONSIBILITIES:

• Manage CDMOs and review contracts, invoices, and payments
• Interface with QA, SMEs, and regulatory in the management of all aspects of CMC development
• Review or initiate CMC related documents
• Work closely with SMEs and CMOs to ensure all CMC deliverables and activities are aligned with corp. objectives
  • Coordinate all CMC sub-team meetings, documenting meeting agenda and minutes, and managing action items
  • Implement CMC strategy
  • Identify potential risks and risk management strategies
• Collaborate with SMEs for election of new vendors, release batches, API, drug product
• Inventory management
• As needed, work closely with SMEs in the lab to resolve CMC product development formulation related issues

• PhD with 5-10 years’ experience in AAV CMC drug development function,
• Experience in early stage drug development and manufacturing

• Experience in CMO management
• Experience in risk identification and mitigation
• Ability to work independently (with minimal supervision) in a fast-paced team environment.

• Knowledge of cGMP requirements for pharma / biotech industry
• Biologics experience 
• Regulatory environment
• Process, procedures and best practices
• Proficient in Microsoft Office (Word, Excel, and Power Point) and Smartsheet

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