Operations Manager- GMP

Location: Burlington Cleanrooms On Demand
Department: Azzur Cleanrooms On Demand Burlington LLC

Job Description

Azzur COD is looking for an Operations Manager. This employee will be a Cleanrooms On-Demand Burlington business unit (Facility Solutions) leader in providing operational support for facility and client activities. 

This employee is a Cleanrooms On-Demand business unit (Facility Solutions) leader in providing operational support for facility and client activities. Responsibilities include ongoing operations to ensure service delivery and new business fulfillment. Responsible for employees supporting facility and warehouse operations, client startup, and continuous business improvement at Cleanrooms On-Demand facilities in COD Burlington, MA

Essential Functions:
 Provide direction and skills coaching to develop and maintain a facility operations team ensuring the safe and reliable operation of the facility and its critical, continuously operating systems and equipment.

Provide direction and skills coaching to develop and maintain a warehouse operations team effectively supporting all supply chain client requirements.

Work closely with the External Client Project Management team to deliver tech transfer and daily operational support for client operations.

Identify and lead continuous improvement efforts that build standard work processes and develop tools to improve business operations.

Lead internal engineering and validation efforts for onsite equipment and engineering challenges, ensuring that internal equipment is maintained in a qualified/validated state and that non-routine client equipment requests are fulfilled with coordination from the External Client Project Management Team. 

Requirements:

  • 5 years of experience in Facility Operations, Material Management, and/or Tech Transfer Project Management in the Biopharm industry.
  • 3 years of Supervisory experience.
  • Professional experience in the regulatory requirements and expectations of the Biopharmaceutical industry.

Required Education:

  • Bachelor of Science degree from an accredited institution

Fulltime Employment with Azzur can offer you:

  • Flexible PTO
  • Training and Development Opportunities
  • 401(k) match
  • Bonus Eligibility
  • Medical Benefits
  • Paid Holidays
  • Company provided laptop

The Cleanrooms On Demand model is an alternative to building out new cleanrooms or utilizing a CMO.  Our clients utilize the cleanroom space and facility infrastructure (such as EM, waste management, security, etc.) with the option to add on additional services as needed, while maintaining ownership of their IP and their process.  In essence, we provide the GMP envelope around the clinical manufacturing activities that our clients perform in our cleanrooms.  The goal for our clients is an accelerated timeline to clinic, flexibility, and cost savings.

Azzur Group is an equal opportunity employer and promotes diverse culture, ethnicity, gender, and age in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.




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