Drug Product Process Scientist
We are seeking a highly skilled Drug Product Process Scientist to join our team at Pfizer's state-of-the-art Dublin Grange Castle site.
About the Role:
The successful candidate will be responsible for providing process science support and new product technology transfer into the Parenterals Drug Product Manufacturing Suite.
Main Responsibilities:
* To be a 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.
* 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.
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).