Lead or participate manufacturing activities, during the technology transfer, qualification, and validation batches
Lead or participate API new process/production set up, equipment qualification etc.
Write the Batch Record documents ensuring that the requirements of the relevant parties are all accommodated.
Perform lab familiarisation or user-test to demonstrate the process and material suitability prior to the campaign running in Pilot Plant
Provide technical cover (running in-process checks and controls as required) during the processing period.
Review all the batch documentation post manufacturing. Assessing any process deviations. Initiate, participate or lead investigations when appropriate
Requirement
Bachelors/Masters/PhD degree in a technical/science field, including Chemistry, Biochemistry, Chemical Engineering or Pharmaceutical Science
Technical experience in process chemistry, pharmaceutical manufacturing process, tech transfer, commissioning, and validation in pharmaceutical industry.
Demonstrated process development skills, including the ability to deliver innovative process chemistry at scale
Proven scale up skills, to facilitate the successful transition from laboratory to full scale production.
We would like to invite interested applicants to apply.
Thomas Tan Registration No: 12C6253 License No: R2094900
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