Senior Process Engineer - CGT
A Global Leader in Life Sciences is looking for a Senior Process Engineer to join them in Cell & Gene Therapy, in Singapore. This is the opportunity to progress within an organisation which is committed to saving patient lives worldwide and developing innovative therapies.
Duties and Responsibilities:
* Perform analysis and design of process fit and process-scale up in collaboration with vendors, customer technical experts or Process Development and MSAT teams of other sites.
* Design and perform experiments on scale down process in MSAT lab to support process technology transfer. Follow all applicable lab safety policies.
* Author, review and/ or approves of process-related documents i.e. Process overview, APS protocols, development/ investigative protocols and reports.
* Develop and define training programs and requirements to facilitate integration of new manufacturing process production facility.
* Interact with customer technical experts as necessary to progress technology transfer.
Process support:
* Performs technical review/ approvals of batch records, process SOPs, deviations, change controls, training documents, protocols, development/ investigative reports, CAPAs.
* Support investigations into process issues/ deviations and if required, coordination of the associated troubleshooting activities and/or perform experiments in the MSAT small-scale cell culture process lab. Follow all applicable lab safety policies.
* Manage change control implementation for process changes that are driven by process changes/ improvements and coordination of non-GMP and/or non-clinical runs.
* Lead/ support pre-campaign preparation activities. Oversight on the production floor to provide support and review of operations. Escalate issues to management appropriately and interface with customer on issue resolution.
* Oversight of on-going trainings to ensure alignment between training and process requirements.
* Monitor manufacturing run process data and monitor for run-to-run consistency.
* Identify and drive implementation of process improvements as required. Support inspections and audits by customer and regulatory authorities as required.
* Support plant start-up and pilot/clinical/commercial run. Perform technical investigations and help author technical reports to support close-out of deviations, trouble-shoot process excursions/issues in operations, and participate in the generation and assessment of required change controls.
* Able to recognise abnormalities and/or potential event that might affect process, product quality and/or safety & escalate promptly to the appropriate level for attention.
Requirement:
* Degree in a relevant Science field or Equivalent. Relevant 7- 10 years work experience in Lab experience in a biotech or development services, R&D, healthcare and lifescience field would be advantage Knowledge of Excel as well as Statistical Data Analysis tools
* Bio Assay Area: Understanding and execution of ELISA, potency , PCR and FACS methods.
Please click the link to apply and reach out for more information.
EA License Number: 16S8194