Job Description
The GMT Analytical Scientist role, within Global Manufacturing Technologies - Analytical (GMT-A), is responsible for supporting the provision of analytical technical services. This role supports GMT on projects such as analytical method transfer exercises (AMTE), analytical method development and validation of analytical test methods for in-process and final product testing for biopharmaceutical products. This role also supports technical investigations of analytical methods associated with testing of recombinant antibodies for use in the veterinary field and regulatory submissions relating to analytical methods.
This role involves highly collaborative interaction with other stakeholders to contribute to projects and timelines including external contract testing service providers and global teams.
Position Responsibilities
Support of routine operations:
- To support the development, optimization and validation of analytical test methods, either inhouse or in collaboration with external service providers.
- Support AMTE to and from Zoetis Tullamore site
- Work closely with all teams and departments to ensure work practices and targets are achieved in line with the business targets and objectives.
- Operate, monitor, and maintain technical equipment to ensure optimal performance and longevity, ensure equipment usage is documented and the required technical servicing is arranged/supported.
- Communicate, collaborate, and cooperate with all stakeholders to support AMTE and new assay and product introduction.
- Authoring of technical documents, including relevant test methods, SOPs, training material, testing protocols and reports.
- Troubleshooting complex analytical methods and supporting investigations in QC and GMT as required.
- Authoring of and supporting deviations, change controls, validation events, system suitability failures as required Assist with the implementation of corporate global policies, site and business specific guidelines within the site GMT-Analytical team.
- Involvement in the compilation of regulatory submissions and the response to questions from regulators.
- Training of other analysts in analytical methods.
- Communication and presentation of technical information.
- Acts as a role model for the G M T Analytical team and the wider organization in adherence to the Zoetis corporate core values and local site shared commitments/behaviors.
- Follows all site H&S guidelines , ensure all tasks applicable to the role are carried out in a safe manner, and report incidents in ·required timelines.
Compliance and Continuous Improvement:
- Assist with regulatory inspection and internal audits to meet the GMT-A teams targets and goals, as applicable.
- Develop a strong understanding of current Good Manufacturing Practices (GMP) and required Good Documentation Practices ( GDP).
- Ensure documentation meets the relevant GMP and GDP requirements to ensure department compliance / readiness, as applicable.
- Participate in and identify new continuous improvement initiatives.
Organisational Relationships
- Reports to the GMT Analytical Team Leader.
- Strong working relationships with Tullamore QC, QA, Operations, GMT and support teams including Global GMT transferring laboratories and VMRD teams as required.
- Provides OJT to colleagues within GMT and QC.
Resources Managed
Supervision
• N/A - this role does not have direct reports.
Education and Experience
- BSc, MSc in a relevant discipline (e.g. biochemistry, protein chemistry, analytical chemistry) or equivalent experience.
- 2+ years' relevant experience in laboratory analysis (e.g. QC , bio-analytical in-process / final product in relevant analytical methods such as LC, CE -SDS, ELISA, glycan analysis).
- Technical writing skills to support writing of a range of documents including reports, protocols, test methods and SOPs.
- Ability to learn quickly and take responsibility for tasks/projects.
- Knowledge of and/or experience n analytical method transfer and validation.
- Working knowledge of operating in a GMP environment.
Technical Skills Requirements
- Laboratory skills in a range of analytical methods (may include pH, appearance, measurement of protein concentration, ELISA, LC-based methods, CE-SDS, clEF).
- Excellent interpersonal, verbal, and written communication skills.
- Able to think critically and demonstrate troubleshooting and problem solving skills.
- Self-starter and self-motivated; organised with good attention to detail.
- Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities.
- Results oriented, with the ability to manage multiple priorities in a short period of time.
- Attention to detail, process and procedural compliance, and results driven.
Physical Position Requirements
Role is based at the Tullamore, Ireland.
Normal activities would include, but are not limited to, some minor lifting of small items, sitting/standing at a desk working on documents/reports/protocols/reviewing data etc, some standing while working in laboratories or observing/reviewing process or procedures, walking around and between laboratories and buildings, ability for some travel (minor), support / attend limited department and GMT meetings outside of normal local business hours (to support international / global projects / goals).
Full timeLegal statement as below
This job advert indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent. Incumbent may be asked to perform other duties as required. Additional position specific requirements/responsibilities are contained in approved training curricula.
Visa status re must be eligible to work and live in Ireland as below
Colleague must be legally eligible to live and work in Ireland.
Summary of our Benefits
In addition, to being part the world leading animal health company focused on the needs of those who raise and care for animals we offer a range of benefits such as competitive salary, bonus, 25.5 days holiday per annum plus public holidays, a defined contributory pension plan, private medical insurance for you and your family and empowered flexible working, to name a few. Please note that the benefits outlined are subject to change based on organization decision.