Manufacturing Associate - Manufacturing Support Specialist

  • Job ref:


  • Location:

    Norwood, United States

  • Sector:


  • Job type:


  • Contact:

    Nicholas Haun

  • Published:

    about 4 years ago

(Contract) Manufacturing Support – Specialist

The Role:

Seeking a cGMP Manufacturing Support team member for our new site in Norwood, MA.

The individual in this role will be part of a cohesive team responsible for producing high quality mRNA-based medicines for evaluation in human clinical trials.  The Manufacturing Support Specialist team member uses knowledge of cGMP regulations and biopharmaceutical production processes to assist in investigations, document generation and improvement initiatives within manufacturing operations or other departments as needed. They will work directly with subject matter experts to ensure content accuracy, improve efficiency and documentation practices.

Here's What You’ll Do:

  • Practices and promotes safe work habits and adheres to safety procedures and guidelines
  • Utilizes manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement
  • Participates in cross functional teams to drive complex investigation close outs, determine root causes and implement appropriate corrective and preventative actions
  • Conducts document revisions and/or document management including but not limited to batch production records and manufacturing procedures
  • Performs training with staff on the floor as needed
  • Participates in cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology
  • Works independently with minimal supervision and direction
  • Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion
  • Creates and presents trending and metrics reports
  • Assists in the monitoring of production processes
  • Participates in equipment start-up, commissioning, and validation activities and ensures operational readiness
  • Assists with troubleshooting in case of equipment or process failures
  • Participates in defining robust process parameters and trending during routine manufacturing campaigns
  • Assists in the optimization, trend, and report manufacturing process operational parameters during manufacturing campaigns

Here’s What You’ll Bring to the Table:

  • Bachelor's Degree in relevant scientific discipline with a minimum of 2-5 years experience (or MS in relevant scientific discipline with 0-2 years) in Biopharmaceutical operations
  • Understanding of biologics drug substance purification operations (such as liquid chromatography, TFF, aseptic technique) or a similar complex specialized environment
  • An understanding of regulatory requirements and their applications in a cGMP environment
  • Experience with electronic documentation systems for controlled documents in a cGMP environment 
  • Excellent written and oral English language skills
  • Bachelor's degree in Engineering or Life Sciences is preferred
  • Demonstrated ability to lead cross functional teams and deliver results with minimal supervision
  • Ability to manage multiple competing priorities in a fast-paced environment
  • Understanding of lean manufacturing methodologies and operational excellence