Drug Product Manufacturing Associate I

This is a temporary-to-hire, on-site position supporting bulk formulation and/or filling operations for sterile liquid injectable pharmaceutical products under cGMP regulations. The role is Monday-Friday, 8 hours/day (excluding lunch) with a flexible start between 7:00-9:00 am. Overtime, weekends, and holidays may be required.

Duties and Responsibilities

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  Perform various routine manufacturing tasks under the direction of internal SOP's and cGMP guidelines

  
  


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  Prepare material components for manufacturing operations

  
  


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  Document steps clearly and completely in production batch records, logbooks and other controlled forms

  
  


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  Participate in inspection readiness activities

  
  


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  Perform basic arithmetic and algebraic computation

  
  


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  Maintain cleanliness of areas and equipment

  
  


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  Assist senior level personnel in bulk drug formulation using a variety of lab equipment including mixers, balances, pH meters, etc., gowned in accordance with Class C (ISO 7) conditions

  
  


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  Assist senior level personnel in sterile filtration activities, gowned in accordance with Class C (ISO 7) conditions

  
  


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  Assist senior level personnel in sterile filling of a multitude of solutions including drug product, media, buffers, using an automated filling and closing machine, gowned in accordance with Class C (ISO 7) conditions

  
  


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  Collect and dispose of lab wastes according to established procedures

  
  


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  Collaborate in continuous improvement activities

  
  

Education and Experience Requirements

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  High school diploma or equivalent with 1 - 2 years relevant experience is required, a Bachelor's in an Engineering discipline or Life Science field preferred

  
  


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  Time and project management skills with the ability to multi-task are essential

  
  


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  Must be able to effectively communicate within department and cross-functionally with other divisions

  
  


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  High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction

  
  


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  Experience in a growth-oriented, cGMP contract manufacturing organization with a focus on compliant execution of business, is a plus