Aseptic Training Manager - Small Molecule

Posted 27 April 2023
Salary Competitive
LocationNorth America
Job type Full Time
DisciplineSmall Molecule
Contact NameThomas White

Job description

Mantell Associates is partnered with an expanding organisation in search for a Aseptic Training Manager.


  • Develop Aseptic Training program for August Bio that instructs personnel on gowning, aseptic technique and expected work conduct to maintain sterility in the classified areas of the facilityDevelop attainable training plans for new employees (Manufacturing, Engineering, QC, Sanitation, EM), as applicable

  • Train new and existing employees on Aseptic training program as applicable

  • Ensure existing colleagues maintain their certifications by scheduling and performing training, as applicable

  • Plan and provide overall support for Aseptic Media Fills

  • Develop/improve/update necessary training materials

  • As Aseptic SME, perform necessary Aseptic assessments

  • Responsible for maintaining working knowledge of current Good Manufacturing Practices (cGMPs) and emerging regulatory and compliance concerns as related to aseptic manufacturing

  • Work with cross-functional groups to improve the current Aseptic, Sanitation and EM training programs


  • A bachelor’s degree in a relevant field

  • 6+ years’ experience in an aseptic environment supporting aseptic manufacturing

  • Excellent communication (oral/written), facilitation and presentation skills

  • Good knowledge of GMP and Regulatory requirements as related to aseptic manufacturing

  • Self-directed and capable to make and act upon decisions that impact the site from an aseptic standpoint

  • Able to assess training needs for individual and area

  • Experienced in aseptic gowning and aseptic techniques

  • Experienced in pharmaceutical sanitation and disinfection techniques

  • Technical Training experience in a lab or manufacturing environment

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.