Senior Process Manager
- Ireland, Dublin
- Contract
- Life Sciences
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:
- Support the design, construction and qualification of upstream & downstream equipment
- 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
- Lead and support various manufacturing science and technology organisational initiatives as needed
- Maintain continuous focus on quality and safety compliance and unflinching focus on the customer
About you:
- Directly related experience in academia, pharmaceutical or biotechnology company – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practice
- Self-starter and results focused
- Excellent oral and written communication skills
- Bachelor's degree or higher in Biological Sciences/Chemical Engineering/Chemistry
- Proven track record in delivering excellence
- Experience with upstream cell culture and/or downstream purification of biological molecules.
- Experience with tech transfer, regulatory filling and commercial drug substance manufacturing of biologics is a plus
- Working knowledge of statistical methods of DOE design and data analysis
Interested in this role? Apply today!
#LI-DH1
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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Dawn
I manage this role.