Cpl in partnership with our client Pfizer are seeking a Drug Product Process Scientist to join the team for an 11 month fixed term contract at their state of the art Dublin Grange Castle site. This is a hybrid working role.
Parenterals Technical Services works to anticipate and deliver on the process technology needs of the business, including sustaining ongoing operations, technical transfers, cleaning validation, process optimization, and major investigation support. This is an ideal development opportunity to join a dynamic team who provide process science support/ new product tech transfer into the Parenterals Drug Product Manufacturing Suite at Pfizer Grange Castle.
The jobholder works within the Drug Product Technical Services team and requires the flexibility to move from one project quickly or to work on multiple smaller projects at the same time.
Our Culture is hugely important to us at Grange Castle. It is the embodiment of how we act, lead, and engage with people every day. Our vision is, together, we deliver life changing medicines to our patients. Our success is achieved through the commitment, engagement, and excellence of all our colleagues.
We Are Seeking Process Scientists whose Role Will Be:
· Key member of the Drug Product tech transfer team within the Parenterals Manufacturing Suite.
· Capture all aspects of the existing process and equipment to ensure that an equivalent process is transferred to Grange Castle.
· Technology Transfer, including Gap Analysis, Process Transfer Risk Assessment, process description, new material introduction support etc.
· Execute requisite process trials to facilitate transfer as required.
· Develop process validation protocols and lead their execution in conjunction with Operations.
· Generate process validation summary reports and associated filing submissions.
· Liaise with site functions – logistics, planning, QA, QC, Operations, Regulatory Affairs to support the process transfer to GC.
· Support major process investigations as requested and support the implementation of CAPAs.
· Provide technical training on process and technology areas as required by the project.
· Support site operational readiness (equipment, process understanding etc.).
· Deliver presentations that distil complex ideas and proactively communicate results and progress to technical teams, management, and business leadership.
· Be competent with Quality Systems, including Change Controls, Commitments and Maintenance systems.
Requirements
· Minimum of 2 years’ experience of Drug Product Manufacturing.
· Knowledge of technical transfers preferable.
· Demonstrated aptitude for technical learning and problem solving.
· Good communication skills.
· Experience of FDA and EU licensing desirable.
Skills:
• Demonstrated technical capability and aptitude for technical learning.
• Strong evidence of problem-solving/trouble-shooting skills.
• Ability to independently plan and perform work assignments, interpret and present data.
• Capability of working in a multi-disciplinary team environment.
• Strong interpersonal skills with an ability to work independently across sites and teams.
• Highly motivated, proactive, and persistent.
• Effective communication (verbal, written).