Supervisor, Downstream Manufacturing (1st Shift)
Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility...
Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility...
and application of global regulatory guidance (e.g., FDA, EMA, PMDA, etc.) that are essential in designing drug development strategy...
Responsibilities: Execute CSV activities in accordance with regulatory requirements (e.g., FDA, EMA, GxP) and industry standards (e.g...
to have). Experience executing USP chemical identity tests for raw materials Knowledge of FDA, EMA and ICH regulations, industry standards...
that all CQV activities and deliverables adhere to industry regulations, standards, and best practices (e.g., FDA, EMA, GMP...
federal, state, and local regulations (e.g. GDPR), rules, policies, and procedures such as FDA Guidance on Data Integrity, EMA...
, or gene/cell therapy manufacturing. Experience with authoring and review of regulatory documentation (FDA, EMA...
Responsible for facilitation of training, including training GVP Modules and key relevant US & EMA safety-related Guidance...
requirements throughout the lifecycle of each product. Serve as the primary liaison with regulatory agencies (FDA, EMA... collaboration and team leadership. In-depth understanding of global regulatory standards and processes (e.g., FDA, EMA...
ensuring compliance with GxP, FDA, EMA, and other regulatory bodies' guidelines and industry practices. Report Writing... (FDA, EMA). Digital Platforms & Tools: Familiarity with platforms like Veeva, LinkedIn, and Instagram as related...