Support the timely and successful transfer of customer's manufacturing process into the Lonza Bioscience Singapore production facility.
Work with other MSAT team members, technical experts from Lonza's customer companies and work cross functional team
Perform analysis and design of process fit and process-scale up in collaboration with vendors, customer technical experts or Lonza's 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 and/ or review of process-related documents i.e. Process overview, APS protocols, development/ investigative protocols and reports.
Process support
Performs technical review 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.
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.
Monitor manufacturing run process data and monitor for run-to-run consistency.
Support inspections and audits by customer and regulatory authorities as required.
Requirements
Degree in a relevant Science field or equivalent
Individual without prior working experience in the biopharmaceutical manufacturing industry may also apply
Understanding of the application of mammalian cell culture for the production of biopharmaceuticals
Understanding of cGMP regulations
Good problem solving and analytical skills
Good communication and teamwork skills
About Lonza
Ready to shape the future of life sciences?
Additional Information
The training period lasts for 15 months . Structured on-the-job training (OJT) will be provided and conducted at the participating companies to facilitate the application of learning and to ensure that individuals acquire necessary competencies to perform at their job.
This position will be based at Singapore Tuas site, under MSAT (Cell Gene Therapy) team.
What you'll get:
An agile career and dynamic working culture
An inclusive and ethical workplace
Daily company bus from the MRT location near your home to and from the Tuas site
The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits
Lonza · Sg - Tuas, Singapore