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:
- Execute all downstream process operations in the MS&T laboratories, including column chromatography, UF/DF, filtration, and associated sample handling activities.
- Design, plan, and execute experimental studies to address manufacturing challenges, process deviations, and continuous improvement opportunities.
- Support upstream MS&T laboratories through bioreactor sampling, data collection, and documentation of experimental results when required.
- Provide support to process analytics MS&T laboratories through the execution of specific analytical assays and interpretation of analytical data.
- Analyze, trend, and summarize experimental and manufacturing data, preparing technical reports and presentations to support decision-making.
- Support troubleshooting of manufacturing process-related events, deviations, and investigations, utilizing scale-down models where appropriate.
- Participate in the evaluation, introduction, and qualification of new process technologies, materials, or equipment.
- 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.
- Contribute to technology transfer activities and process characterization studies as required.
- Ensure compliance with site safety standards, training programs, cGMP requirements, and regulatory expectations, maintaining a strong focus on data integrity and documentation practices.
- Assist with the preparation and review of SOPs, protocols, reports, and other controlled documents relevant to MS&T activities.
Requirements:
- Degree in Biological Sciences, Chemical Sciences, Biochemical Engineering, Chemical Engineering, or a related discipline is preferred.
- Minimum of 1 year of direct laboratory experience in a downstream processing environment (e.g., chromatography, UF/DF, filtration).
- Strong organizational skills with excellent attention to detail and the ability to manage multiple priorities in a fast-paced environment.
- Demonstrated ability to interpret, analyze, and clearly communicate scientific and technical data in both written and verbal formats.
- Ability to identify scientific or operational gaps and proactively propose practical, data-driven solutions.
- Self-motivated individual capable of working independently, while also contributing effectively within cross-functional teams.
- Familiarity with cGMP environments, regulatory expectations, and standard laboratory documentation practices is highly desirable.
- Experience supporting manufacturing operations or MS&T functions within biologics or pharmaceutical industries is an advantage.
#LI-PC2