Scientist
Contract ExecutiveJob Overview
We are seeking a highly skilled Scientist in Technical Services / Manufacturing Science (DRY-EM TS/MS) to provide scientific and technical support for manufacturing operations. This role is responsible for ensuring manufacturing processes are reliable, compliant, and capable of consistently delivering high-quality products, particularly within spray drying and solid dosage manufacturing environments.
The position requires strong collaboration with cross-functional teams and external partners to support process performance, resolve issues, and drive continuous improvement.
Key Responsibilities
- Provide technical oversight for spray dry, solid dosage manufacturing and packaging
processes, leveraging a strong technical foundation and previous experience supporting these processes. - Participate in resolution of technical issues, including those related to control strategy and manufacturing.
- Possess excellent technical writing capabilities, including authoring of deviations and change controls.
- Employ excellent communication skills to manage internal and external relationships with external partners, site management, and cross-functional teams.
- Build and maintain relationships with development and central technical organizations.
- Ensure that manufacturing processes are compliant, capable, in control, and maintained in a validated or qualified state.
- Understand, justify, and document the state of process validation with data that evaluates the capability of the manufacturing process to meet its stated purpose.
- Maintain processes in a state of compliance with US and global regulations, including cGMPs and applicable global regulatory manufacturing guidance.
- Support ongoing manufacturing at External Partners through process monitoring, issue response, and process improvements where necessary.
- Support technical transfer and validation activities to external partners manufacturing and packaging sites.
- Work cross-functionally within the site and other functions to deliver on technical objectives.
- Some flexibility may be required to support 24/7 operations and issue resolutions with external partners across different time zones.
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