Bioprocessing Associate, Upstream
Job Summary: Job Incumbent will work with Manufacturing teams to support the production of biological products. This role will be responsible for procedures and processes associated with the manufacture of clinical and commercial and will support the night shift during upstream manufacturing. Job Responsibilities: Assist in maintaining a safety-oriented culture, cGMP compliant work environment at all times Complete all training in a timely manner. Maintain assigned training, ensuring full compliance at all times. Assist in all production operations in the assigned area as directed by the relevant Standard Operating Procedures (SOPs) and Batch Records. Report issues identified during routine operations to the Senior Team Member and/or Manager and perform initial troubleshooting as needed. Support shift work during the cell culture stage in the bioreactor. The shift pattern may be varied according to business requirements and will typically require night and weekend working. Perform all duties in accordance with GMP requirements, SOPs and controlled documents. Perform housekeeping duties as assigned to maintain facility at a high standard. Support Facility and Equipment start-up and Validation activities. Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new equipment as needed. Support deviation investigations and process optimizations using scientific, engineering and lean principles. Support in reviewing Executed Batch Records as needed at a high GDP standard. Job Requirements: Nitec/Diploma/Degree in Science, Engineering or related field. Able to perform overtime and work during Public Holidays. Able to support Night Shift and weekend shift. 0-3 years’ experience in biopharmaceutical or pharmaceutical cGMP manufacturing. Experienced in the Mab Upstream Manufacturing function at a similar size and scale is an advantage. Good knowledge of current Good Manufacturing Practices (GMP) Knowledge of biopharma manufacturing processes and their translation into documentation such as batch records and SOPs Knowledge of bioprocessing/biotechnology and Mab Upstream biologics processes. Able to work well in fast paced environment with cross-functional teams Excellent communication, interpersonal and presentation skills. Collaborative and inclusive approach to team members. Excellent problem solving and trouble shooting skills. Flexible approach to work and a positive attitude will be a good fit within the team dynamic. Engage cross functionally in conjunction with a site-based team. Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and customers’ expectation. Contract Duration: 12 months, subject to renewal, based on performance.