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BioPharma Consulting JAD Group
Carolina, Carolina, PR
Source: BioPharma Consulting JAD Group careers · View original posting
From BioPharma Consulting JAD Group's posting. “We” and “our” refer to the employer.
Under limited supervision the Technical Services / Manufacturing Science (TS/MS) Scientist – Dry External Manufacturing will performe the following tasks and duties:
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.
Participating in root cause investigations to support Corrective Actions and Preventive Actions (CAPA) closure Activities within the expected timeline.
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 by review technical transfer documentation, participate in process qualifications activities and support validation campaigns.
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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