Senior Development/ MSAT Scientist
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there is no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
The role will independently lead the technical transfer of multiple concurrent manufacturing processes (either Cell Culture and/or Purification – USP/DSP) from Process Development, Pilot Scale and other sites of manufacture to GMP operations in Hayward. This role will be a recognized process expert. Supporting multiple customer project teams to deliver manufacturing processes in negotiation with external customers as well as other internal cross-functional teams. This role has the opportunity to develop an extensive internal network.
- Working collaborately within the Cell Therapy management team:
- Ensures department functions and personnel comply in accordance with site EHS standards (policies, rules and regulations).
- Manages recruitment and co-ordinates training to maintain budgeted headcount.
- Sets individual personal development goals and provides appropriate coaching and performance feedback.
- Inputs into salary and promotion review. Pro-actively manages (with HR) inadequate performance following site procedures.
- Develop and continuously improve template for rapid, efficient and accurate tech transfer execution.
- Lead a team of MSAT Process Engineers in executing timely and successful transfer of customer’s manufacturing process into the Lonza Bioscience Singapore production facility.
- Work collaborately with:
- Lonza global MSAT and customer SME representatives
- Manufacturing team on training and resource planning for execution of pilot runs/engineering runs/ non-clinical study runs.
- Supply Chain Management team on reviewing material package for raw materials requirements and bill of materials (BOM) setup.
- Project Management team on project deliverables and customer communications.
- Quality Assurance (QA) team on regulatory and compliance requirements of the manufacturing process.
- Quality Control (QC) team on developing sampling plan.
- Design and direct analysis 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 direct experiments on scale down process in MSAT lab to support process technology transfer. Follow all applicable lab safety policies.
- Define, review and approve process-related documents i.e. Process overview, APS protocols, development/ investigative protocols and reports.
- Identify and define training programs and requirements to facilitate integration of new manufacturing process into Lonza Bioscience Singapore production facility.
- Lead customer technical team meetings and serve as technical lead and SME at Joint Project Team meetings.
- Provide technical input/ assessment on batch records, process SOPs, deviations, change controls, training documents, protocols, development/ investigative reports, CAPAs.
- 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 pre-campaign preparation activities.
- Maintain active team presence on the production floor to provide support and review of operations.
- Maintain team oversight of on-going trainings to ensure alignment between training and process requirements.
- Lead manufacturing run process data collection, analysis and discussion with customer technical experts to identity issues, trends or opportunities for improvement.
- Lead strategy, preparation and discussions during inspections and audits by customer and regulatory authorities as required.
- Lead plant start-up and pilot/clinical/commercial run.
- Direct technical investigations and generate/approves technical reports to support close-out of deviations, trouble-shoot process excursions/issues in operations.
- Generate and/or perform assessment for process related change controls.
- Motivate and direct MSAT team to ensure above responsibilities are met
- Any other duties assigned by your Manager.
- Degree in Chemical Engineering, Biotechnology, Chemistry or a related discipline with strong technical background.
- Significant years’ of experience in Biotechnology process development, process support, research or a related manufacturing environment is advantageous.
- Strong knowledge of and experience with mammalian cell culture experimental techniques and equipment.
- Knowledge of Excel as well as Statistical Data Analysis tools.
- Experience in troubleshooting processing related issues and/or equipment.
- Excellent communication skills, outstanding action orientation, and ability to work well in a fast pace, cross-functional technical environment.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.