Formulation Operator, 2nd Shift

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

 

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

 

 

This role:

The Formulation Operator (Operator III) position will work in and maintain a Grade C/D environment. They will perform routine cleaning and sanitization to help ensure readiness and current Good Manufacturing Practices (cGMP) compliance within the classified and non-classified work areas.  Activities include cGMP compliant gowning, conformance to Good Documentation Practices (GDP) standards, weighing materials, formulation of product, and conducting in-process testing and filtration.  The Formulation Operator may be required to cross-train as a support Operator for additional areas.  This position reports to a Manufacturing Supervisor. 

 

The responsibilities: 

• Understand and follow current Good Manufacturing Practices (cGMP). 
• Perform routine cleanup and sanitizations as assigned by area supervision to maintain cGMP compliance within the Grade C/D work areas.  Perform sanitizations in a timely and effective manner in accordance with cGMPs and Simtra procedures, maintaining production schedule.  
• May be required to cross train as a support operator to assist additional manufacturing areas. 
• Maintain organization at all times within the classified areas to ensure segregation, readiness and to prevent any contamination or rejection of batches. 
• Compare Lot numbers to ensure correct material is being used for the specified batch 
• Complete calculations to determine the amount of material to add based on final weight and sometimes potency 
• Retrieve and test in-process samples  
• Use scales and balances to weigh and add wide range of raw material 
• Clean and sample equipment  
• Assist in the training and development of other team members 
• Required to maintain attendance in accordance with the Bloomington Attendance Policy 
• Scheduled weekend overtime will be required 

Shift: Monday - Friday, 7:00am-3:30pm

The work environment: 

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.  Must be able to occasionally (1-33% of the time) work in a con