MSAT Associate 2

Responsibilities

• Providing support to MSAT Team and working cross-functionally to ensure clear communication across various departments.  
• Management of deviations and other quality records, performing root cause investigations (6M, 5-Why’s, etc) to determine causal factors and evaluate product impact. 
• Training on the cell therapy and/or exosome platforms quickly to assist in product impact assessments, and compiling scientific data relating to the manufacturing processes. 
• Assisting with tech transfers into cGMP Manufacturing, ensuring the transfer is controlled and executed within GMP regulatory guidelines. 
• Supporting Manufacturing group and troubleshooting production activities to ensure safe, quality, and timely manufacture of biopharmaceutical product for pre-clinical, clinical and commercial use. 
• Assisting on revising (as needed) and reviewing process-related manufacturing documentation (batch records, SOPs, bills of material, process flow diagrams) to assure all clinical products meet the requirements for quality, safety and efficacy. 
• Providing in-person and real-time manufacturing production support as needed. 
• Collaborating with Supplier Quality and Manufacturing to evaluate change notifications or material non-conformances.  
• Identifying continuous improvement opportunities and/or corrective actions to increase yield, maximize capacity, improve operational efficiency, reduce costs, and ensure safety while maintaining regulatory compliance in cross functional collaborations. 
• Working closely with Quality department to ensure compliance with cGMP, ICH and FDA regulations. 
• Serving as an organizational change agent and fostering an atmosphere of a questioning attitude, empowerment, and an error prevention/continuous improvement mindset. 
• Performing such other duties as may be assigned to you from time to time.

Requirements

• Bachelor’s degree and 2+ years of hands-on cGMP biologics manufacturing experience in pharmaceutical/biotech industry preferred, or equivalent combination of degree/experience. 
• A minimum of 1 year experience in adherent cell culture. Additional experience with cells in suspension is a plus. 
• Experience with writing/revising technical documents is required (SOPs, Forms, Batch Records, etc). 
• Previous experience with, or knowledge/understanding of, various quality events is required (Deviations, CAPAs, Change Controls etc).  
• Deep understanding of cell culture and ability to troubleshoot common processing issues. 
• Experience with scale-up of cell therapy processes and closed manufacturing systems preferred.  
• Ability to collect and assist in the analyzation/trending of data and information to determine paths for process improvement and potential root cause. 
• Demonstrates technical proficiency, scientific creativity, problem-solving skills, strong GMP principles and collaboration with others. 
• Must have full working knowledge of cGMP regulations. 
• Exceptional communication, presentation, and interpersonal skills. 
• Strong Microsoft Word and Excel skills. 
• Ability to work in a dynamic environment, multi-task, and meet aggressive deadlines. 
• Ability to work independently, as well as work on larger cross-department projects as a team. 

Work Environment & Physical Demands

• Professional GMP facility environment with controlled conditions.
• Ability to sit or stand for extended periods during training and operations.
• Occasional lifting of materials or equipment up to 40 pounds.
• Willingness to work inside an ISO7 cleanroom when supporting manufacturing operations.
• Compliance with gowning procedures and cleanroom protocols for aseptic activities.