Process Development Scientist

4 months ago
Requisition ID
2017-2782
Job Location(s)
Pittsburgh PA United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Scientific

Overview

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. 

 

Responsibilities

• 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

Qualifications

• 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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