Senior Process Manager - Life Sciences - 11-months - Dublin
Do you want to be part of one of the top 10 best companies to work for in Ireland? If so, this could be your chance One of our global pharmaceutical clients is looking for a Senior Process Manager to join their team in Dublin for their new large-scale facility.
This is a fantastic opportunity to be part of fast-paced project; with lots of opportunities to work with and learn about cutting-edge technologies, in addition to developing your own skills.
This is a truly exciting project, which when complete will contribute to the manufacturing of a life changing treatment.
Responsibilities:
1. Support the design, construction and qualification of upstream & downstream equipment
2. Support establishment of the commercial process and routine manufacturing by:Supporting experimental design, execution, data analysis and interpretation. 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 deviation management.Supporting change control prioritisation and implementation.Authoring and reviewing of batch documentation, technical reports and global regulatory submissions.Supporting multidisciplinary teams for process improvement and troubleshooting with end-to-end product focus.Applying LeanSixSigma tools by:Securing continuity of an appropriate LSS/CEM level of knowledge.Facilitating problem solving & risk assessment (FMEA) projects/meetings.Making problems visible and strive for continuous improvement.Serving as a key member during internal audits and external inspections/audits
3. Lead and support various manufacturing science and technology organisational initiatives as needed
4. Maintain continuous focus on quality and safety compliance and unflinching focus on the customer
About you:
5. Minimum of 5 years' (for MSc) or 7 years' (for BSc) directly related experience in academia, pharmaceutical or biotechnology company – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practice
6. Self-starter and results focused
7. Excellent oral and written communication skills
8. Bachelor's degree or higher in Biological Sciences/Chemical Engineering/Chemistry
9. Proven track record in delivering excellence
10. Experience with upstream cell culture and/or downstream purification of biological molecules.
11. Experience with tech transfer, regulatory filling and commercial drug substance manufacturing of biologics is a plus
12. Working knowledge of statistical methods of DOE design and data analysis
Interested in this role? Apply today
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