· Supporting and executing experimental design, execution, data analysis and interpretation.
· Executing satellite runs of the large scale batches
· Interpreting trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
· Supporting and resolving complex deviations
· Authoring and reviewing development operating procedures and technical reports.
· Supporting global regulatory submissions as needed.
· Leading process improvement and troubleshooting with end-to-end product focus.
· Supporting the industry 4.0 initiative to navigate operations in a digital environment.
· Applying LeanSixSigma tools in the Process Sciences group by:
o Securing continuity of an appropriate LSS/CEM level of knowledge.
o Facilitating problem solving & risk assessment (FMEA) projects/meeting.
o Making problems visible and strive for continuous improvement.
· Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.
· Lead and support various organizational initiatives as needed (examples include; technology, safety, financial forecasting, work standardization, etc).
· Represent the organization and present technical and strategic outcomes at scientific and professional forums.
· Keep up to date with scientific and technical developments.
· Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
· Minimum of 3 years directly related experience in academia, pharmaceutical or biotechnology company - along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
· Master's degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry,
· A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams. The successful candidate will also have demonstrated the ability to deliver what is needed on-time, holding self and team accountable for commitments, decisions, actions and behaviours.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists