Senior Lab Operations Specialist

What you'll do

You will have opportunities to participate in various projects and initiatives in addition to these primary responsibilities: 

• Support the Operations team in drug substance and/or drug product manufacturing. 
• Help draft technical documentation for drug product manufacturing. 
• Assist the Operations team with environmental monitoring, cleaning programs, and inventory management. 
• Maintain manufacturing areas and process components to ensure a clean, safe and organized work environment. 
• Work collaboratively with and support the Development Lab and Quality teams. 
• Follow standard operation procedures (SOP) and work instructions to execute tasks.

Qualifications

An effective Operations Specialist will have:

• Minimum of 5 years experience working in manufacturing or laboratory operations required. 
• Ability to work in a clean room environment is required. 
• Pharmaceutical or Medical Device industry experience is preferred. 
• Knowledge of FDA, cGMP, and ICH regulatory requirements is preferred. 
• Must be well organized, attentive to detail and have effective verbal and written communication skills. 
• Must be able to efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment.