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
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.