Lab Operations Specialist

Job Title:  Lab Operations Specialist

Location: Framingham, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. 

Biopharmaceutics Development at Sanofi develops and implements manufacturing processes for biologics starting with an early and strong interface with Biologics Research.  It encompasses cell line development, GMP cell banking, upstream- downstream and formulation development, assay development, GMP clinical biologics production for toxicological and clinical studies, release and stability testing (QC).  Biopharmaceutics development drives identification, development & introduction of new state-of-the-art technologies, and provides launch capable processes and analytical methods at the interface to biologics manufacturing.

Within Biopharmaceutics Development Group in Framingham, the Bioprocessing Engineering (BPE) Laboratory Operations group is responsible for the support of Bioprocess Development and the technical pilot plant including medium/buffer supply, equipment maintenance coordination, materials inventory/supply management.  The Technical Pilot Plant (TPP)  group supports bioprocessing development with process scale production of Monoclonal Antibodies and Enzymes in preparation for Clinical production and investigations. 

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• This individual will join a dynamic and motivated team to support early and late stage development of biological products. 

• The position will support the TPP group through materials supply/ ordering, and equipment maintenance coordination. 

• Materials supply will include management of an external storage vendor including deliveries coordination and purchasing of materials critical to operations in TPP and 31 NYA. 

• Materials supply will additionally Coordinate with and internal stock room vendor assessing the stocking levels required for routine operation. 

• Laboratory Equipment maintenance will coordinate building 31 equipment maintenance PO’s including interaction with Cell Culture and Purification development groups on yearly Maintenance aggregated Purchase Orders and Preventative maintenance activities supporting TPP including Coordination of Equipment calibration through the equipment maintenance provider.  

• The position will work with the technical pilot plant heads and Upstream/downstream development groups to generate and maintain bill of materials (BOMs) for development and pilot scale operations. 

• The BOM’s will support materials supply for projects and budget forecasting support.   

• He/she will ensure that the highest standards of safety and environmental compliance are maintained in the workplace; and operate under the regulatory requirements for biologics product development and manufacturing.

• Develop expertise in purchasing and invoice reconciliation systems in support of ordering for projects in support of BPE and Development groups. 

• Coordinate external storage shipments with vendor including shipping materials for storage and receiving materials for use.

• Work with stockroom supplier to update materials stocking levels, maintain contract, and add/remove materials as needed.

• Work with equipment maintenance provider to maintain equipment service contracts and repairs including review of service contracts with end users and placement of service contract orders.

• Support equipment calibration with the metrology group for the Pilot Plant and Laboratory Operations equipment.

• Work with supervisor, BPE, and development groups to generate and maintain BOMs in support of pilot plant and development activities. 

• Assist with materials forecasts and order materials to support operations at