Process Development Scientist

4 months ago
Requisition ID
Job Location(s)
Pittsburgh PA United States
Less than 10%
Position Type
Full Time
Cook Myosite Inc.


The Process Development Scientist at Cook Myosite Inc. will be responsible for supporting the development of manufacturing processes for cellular therapy products treating a range of muscle-based conditions and diseases.  This is a predominantly laboratory based role, with expectations to perform experimental work in accordance with industry best practices and external regulatory requirements for GMP. 



• Provide continual development of mammalian cell product manufacturing processes (cell isolation, culture, cryopreservation, formulation and fill), including scale-up and control strategies
• Design, execute laboratory experiments, analyze data, and author technical reports to support process development
• Develop strategies, methods, and controls for internal material preparation and use
• Transfer robust processes to production groups 
• Develop SOPs and other documents for implementation into GMP environment
• Provide troubleshooting and root cause analysis for manufacturing-related investigations    
• Generate high quality documentation to support regulatory filings and maintain proper documentation of all experimental procedures and results
• Identify and evaluate emerging technologies to determine their applicability in gaining process efficiency and/or improving product safety and quality


• Bachelor's degree with 5+ years related industry experience or graduate degree (MS or PhD) with 3+ years related industry experience in process development for biopharmaceutical or related products

• PhD in biological sciences or relevant field is preferred

• Experience in late phase biologic/drug development is preferred

• Knowledge of the regulatory environment, particularly principles of GMP, process validation, pharmaceutical development, quality by design, and risk management
• Broad experience with cell culture and aseptic techniques
• Must be independent and able to proactively apply knowledge in the design, execution and transfer of processing methods
• Ability to effectively document and communicate results



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