Aseptic Training Manager - Small Molecule

Posted 18 May 2023
Salary Competitive
LocationNorth America
Job type Full Time
Discipline Large MoleculeSmall Molecule
Contact NameThomas White

Job description

Mantell Associates is partnered with a rapidly expanding organisation in their search for an Aseptic Training Manager to join their talented team.

  • Requirements:

      • 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

    • Responsibilities:

      • 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 facility

      • 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

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