Technical Services Chemist
Pfizer Pharmaceuticals, Little Island
The facility manufactures synthetic chemicals of bulk active pharmaceutical ingredients (API) for use in the pharmaceutical industry. Pfizer has recently completed 50 years in Cork and it's an exciting time for you to be a part of their API site as you will be supporting the new projects whilst gaining experience working in a matrix environment.
The Technical Services Chemist will have detailed chemistry knowledge of the various site products / processes and will provide relevant process & analytical technical advice to various site functions to ensure optimal performance of the product / process on plant.
Scope of Responsibilities:
- Ensure detailed chemistry knowledge of designated processes is available and understood to ensure full support of production campaigns is provided. This includes detailed understanding of research development studies and experiments completed in determining critical and key parameters of various processes.
- Design, perform and analyse experiments / studies to mitigate issues prior and during manufacturing campaigns. When necessary, provide analytical support, in addition to QC, for process related investigations and campaign start-ups.
- Take ownership for delivering improved robustness of designated processes from a quality, safety and cost perspective.
- Take responsibility for the design, development and maintenance of validation / qualification procedures, protocols and reports, including writing documents, performing and supporting validation & qualification processes.
- Design, develop and maintain cleaning evaluation reports, cleaning validation procedures, protocols, and reports.
- Support Process Team(s) through active, core team membership, including writing campaign reports, contributing to periodic product reviews (APRs) and supporting day-to-day process team activities
- Support transfer of products/ processes in and out of the site and adapt processes where necessary to best suit the LI site equipment. Liaise with sending / receiving locations on product transfers and implementing changes and improvement to current processes.
- Provide technical and hands-on support to manufacturing and QC department to ensure process understanding is shared across all departments. When necessary, provide training to relevant colleagues on-site.
- Devise, implement and maintain process controls, including process analytical technology and / or in-process testing to mitigate issues from manufacturing processes.
- Perform chemical process investigations as required to support changes in regulatory/ corporate standards and ensure compliance with applicable GMP, EHS, and PQS standards.
- Provide technical support to ensure safe use and management of chemicals, including chemical reaction hazard identification, testing and evaluation.
- Design, develop and maintain a mass balance and a Master Raw Material List as appropriate.
Minimum Qualification Requirements:
PhD degree desirable with 1+ years' experience in an API manufacturing environment.
Kindly contact me at Shyni.Fernandez@cpl.ie to learn more about this opportunity !