Job Summary:
Our client, a world-renowned Biologics company, is seeking to recruit a Scientist within Manufacturing Science and Technology (MS&T) to support the operation of the downstream laboratory on a 12 month contract. This role will also provide cross-functional support to upstream MS&T and process analytics teams as business needs require. The successful candidate will play a key role in supporting manufacturing operations, process understanding, and continuous improvement initiatives within a cGMP environment.
Responsibilities:
1. Execute all downstream process operations in the MS&T laboratories, including column chromatography, UF/DF, filtration, and associated sample handling activities.
2. Design, plan, and execute experimental studies to address manufacturing challenges, process deviations, and continuous improvement opportunities.
3. Support upstream MS&T laboratories through bioreactor sampling, data collection, and documentation of experimental results when required.
4. Provide support to process analytics MS&T laboratories through the execution of specific analytical assays and interpretation of analytical data.
5. Analyze, trend, and summarize experimental and manufacturing data, preparing technical reports and presentations to support decision-making.
6. Support troubleshooting of manufacturing process-related events, deviations, and investigations, utilizing scale-down models where appropriate.
7. Participate in the evaluation, introduction, and qualification of new process technologies, materials, or equipment.
8. Collaborate cross-functionally with Manufacturing, Quality Assurance, Quality Control, Regulatory, Supply Chain, and Engineering to support facility fit assessments, specification changes, technical evaluations, and change management activities.
9. Contribute to technology transfer activities and process characterization studies as required.
10. Ensure compliance with site safety standards, training programs, cGMP requirements, and regulatory expectations, maintaining a strong focus on data integrity and documentation practices.
11. Assist with the preparation and review of SOPs, protocols, reports, and other controlled documents relevant to MS&T activities.
Requirements:
12. Degree in Biological Sciences, Chemical Sciences, Biochemical Engineering, Chemical Engineering, or a related discipline is preferred.
13. Minimum of 1 year of direct laboratory experience in a downstream processing environment (e.g., chromatography, UF/DF, filtration).
14. Strong organizational skills with excellent attention to detail and the ability to manage multiple priorities in a fast-paced environment.
15. Demonstrated ability to interpret, analyze, and clearly communicate scientific and technical data in both written and verbal formats.
16. Ability to identify scientific or operational gaps and proactively propose practical, data-driven solutions.
17. Self-motivated individual capable of working independently, while also contributing effectively within cross-functional teams.
18. Familiarity with cGMP environments, regulatory expectations, and standard laboratory documentation practices is highly desirable.
19. Experience supporting manufacturing operations or MS&T functions within biologics or pharmaceutical industries is an advantage.
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