Senior Operations Specialist

SKOKIE, IL (ONSITE)

About the Role

We are seeking a highly motivated and experienced Senior Operations Specialist to join a dynamic team dedicated to developing innovative therapies. This organization is a clinical-stage biopharmaceutical company focused on creating first-in-class therapeutic products that address immune-mediated diseases.

As a Senior Operations Specialist, you will play a critical role in implementing and managing manufacturing processes in a regulated environment, contributing to the development of transformative treatments from pre-clinical stages through regulatory approval and commercialization.

Key Responsibilities:

• Support drug substance and drug product manufacturing within a controlled environment.
• Drive new process implementation initiatives and contribute to continuous improvement efforts.
• Create and revise technical documentation related to manufacturing processes.
• Manage environmental monitoring, cleaning programs, and inventory to maintain operational excellence.
• Lead and contribute to cross-functional operations projects to enhance productivity.
• Maintain manufacturing areas and ensure a safe, clean, and organized workspace.
• Collaborate with Development Lab and Quality teams to achieve project milestones.
• Follow standard operating procedures (SOPs) and work instructions to execute tasks effectively.

Qualifications:

• 8–10 years of experience in manufacturing or laboratory operations, preferably in the pharmaceutical or medical device industry.
• Strong knowledge of FDA, cGMP, and ICH regulatory requirements.
• Experience working in clean room environments.
• Excellent organizational skills and attention to detail.
• Effective verbal and written communication skills.
• Proven ability to manage multiple tasks and meet deadlines in a fast-paced environment.
• A proactive approach to problem-solving and process optimization.

Why Join?

This position offers a unique opportunity to contribute to the development of therapies that address the root causes of immune-mediated diseases. You will work in a collaborative and innovative environment where your skills will directly impact the creation of life-changing treatments.

If you’re passionate about making a difference and ready to take on an impactful role, we’d love to hear from you!