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Cpl in partnership with our client Pfizer is 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 aims 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 role offers an ideal development opportunity to join a dynamic team that provides process science support and new product tech transfer into the Parenterals Drug Product Manufacturing Suite at Pfizer Grange Castle.
The jobholder will work within the Drug Product Technical Services team and must be flexible to move quickly between projects or manage multiple smaller projects simultaneously.
Our culture is hugely important at Grange Castle. It reflects how we act, lead, and engage daily. Our vision is to deliver life-changing medicines to patients together. Our success relies on the commitment, engagement, and excellence of all colleagues.
We Are Seeking Process Scientists whose role will include:
* Being a key member of the Drug Product tech transfer team within the Parenterals Manufacturing Suite.
* Capturing all aspects of existing process and equipment to ensure an equivalent process is transferred to Grange Castle.
* Managing Technology Transfer activities, including Gap Analysis, Process Transfer Risk Assessment, process description, and support for new material introduction.
* Executing process trials necessary for transfer.
* Developing process validation protocols and leading their execution with Operations.
* Generating process validation summary reports and managing related filings.
* Liaising with site functions such as logistics, planning, QA, QC, Operations, and Regulatory Affairs to support process transfer.
* Supporting major process investigations and implementing CAPAs.
* Providing technical training on process and technology areas as needed.
* Supporting site operational readiness, including equipment and process understanding.
* Delivering presentations to communicate results and progress effectively to technical teams, management, and leadership.
* Ensuring competence with Quality Systems, including Change Controls and Maintenance systems.
Requirements:
* Minimum of 2 years’ experience in Drug Product Manufacturing.
* Knowledge of technical transfers is preferable.
* Aptitude for technical learning and problem solving.
* Experience with FDA and EU licensing is desirable.
Skills:
* Demonstrated technical capability and aptitude for learning.
* Strong problem-solving and troubleshooting skills.
* Ability to plan and perform work independently, interpret, and present data.
* Ability to work in a multidisciplinary team environment.
* Strong interpersonal skills and ability to work independently across sites.
* Highly motivated, proactive, and persistent.
* Effective verbal and written communication skills.
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