Sr. Operations Specialist (Biotech/Pharma)

About the role

We are seeking a highly skilled and motivated Operations Specialist to join as we embark upon our mission to develop innovative therapeutic products designed to reprogram the immune system and treat autoimmune disorders In this role, you will be responsible for supporting the Operations team by implementing and executing manufacturing processes in a regulated, controlled environment.

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.