Reporting to the Head of Operations MFG11, the Training lead will play a key role in planning, management, and implementation of compliance-related and technical training within the Manufacturing group. This role will act as a key point of contact with the Operations Department Training team ensuring accuracy and compliance of Manufacturing training KPIs, training curricula, and records. During our start-up phase, this role will be crucial in overseeing and ensuring continuous improvement in the training of new Manufacturing staff in Bioprocess associate roles.
Qualifications
~ BSc or MSc in Chemical Engineering, Bioscience, or Biotechnology. A masters level qualification would be advantageous.
~ More than 8 years in biopharmaceutical manufacturing, ideally with experience in both upstream and downstream processing.
~ Experience in dealing with FDA, and/or EMA and CFDA, and have a solid understanding of quality systems in terms of deviation, investigation, CAPA, and change control.
~ Experienced technical trainer.
~ A proficiency in operating a drug substance commercial manufacturing facility and/or a pilot plant.
~ The individual needs to have a good understanding of DQ, FAT, SAT, IQ, OQ, & PQ (commissioning and qualification
~ Experience with GMP systems such as SAP, Orchestrate, benchtop equipment, etc.
~ A proficiency in operating a drug substance commercial manufacturing facility and/or a pilot plant.
~ The individual needs to have a good understanding of DQ, FAT, SAT, IQ, OQ, & PQ (commissioning and qualification).
Pay: $160,000.00 – $180,000.00 per year