About the Role
This is an exciting opportunity to join Pfizer's team as a Small Scale Flex Process Scientist at their state-of-the-art site in Dublin, Grange Castle. The role is for an 11-month Fixed Term Contract and offers hybrid working arrangements.
Job Description
The successful candidate will be a key member of the tech transfer team, working within site Technical Services to support the transfers of new products into the drug substance facility. This includes:
* Capturing all aspects of the existing process and equipment to ensure equivalent processes are transferred to Grange Castle.
* Technology Transfer, including Gap Analysis, Process Transfer Risk Assessment, process description, new material introduction support etc.
* Executing requisite process trials to facilitate transfer as required.
* Developing process validation protocols and leading their execution in conjunction with Operations.
* Generating process validation summary reports and associated filing submissions.
* Ensuring process automation meets the requirements of the process.
* Process input to equipment specification process, including equipment sizing, specification of key components, verification documentation and process instrumentation ranges.
* Liaising with site functions – logistics, planning, QA, QC, Operations, Regulatory Affairs to support the process transfer to GC.
Requirements
To be successful in this role, you will need:
* A minimum of 2-5 years' experience working in a manufacturing process; process development or tech transfer environment.
* Knowledge of technical transfer.
* Demonstrated aptitude for technical learning and problem solving.
* A strong background in mammalian cell culture, protein purification or validation.
* Good communication skills.
* Experience of FDA and EU licensing desirable.
* Knowledge of single use systems and new material introduction.
Skills
You will possess:
* Demonstrated technical capability and aptitude for technical learning.
* Strong evidence of problem-solving/trouble-shooting skills.
* An ability to independently plan and perform work assignments, interpret and present data.
* The 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 abilities.
* Effective communication (verbal, written) skills.
Salary
£60,000 - £80,000 per annum, dependent on experience.
Location
Grange Castle, Dublin, Ireland.
Duration
11 months Fixed Term Contract.