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Promoted
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Katalyst Healthcares & Life SciencesAntioch, Tennessee, USA
14 days ago
Job description
Responsibilities :
Develop and optimize parenteral (injectable) formulations and related manufacturing processes to support clinical and commercial development.
Work with manufacturing unit operations including ultrafiltration diafiltration freeze drying spray drying mixing filling and sterile filtration to ensure robust and scalable production.
Design and execute experiments to evaluate process parameters stability and product quality.
Utilize analytical techniques such as SECHPLC icIEF Karl Fischer titration viscometers fluorescence DSC and UVVis to characterize formulations and monitor process performance.
Apply statistical data analysis tools including Design of Experiments (DoE) using Minitab or JMP to optimize formulations and processes.
Develop and apply process modeling and scientific programming approaches to support process understanding and scaleup.
Independently troubleshoot formulation and process development challenges analyzing data and providing recommendations.
Collaborate with crossfunctional teams including analytical regulatory quality and manufacturing groups to ensure successful product development.
Requirements :
Level II : BS with 46 years of relevant industry experience or MS with 03 years of experience.
Level III : MS or PhD with 5 years of industry experience.
Handson experience with parenteral product formulation and / or process development.
Working knowledge of at least one or more manufacturing unit operations (e.g. ultrafiltration diafiltration freeze drying spray drying mixing filling sterile filtration).
Experience with analytical techniques for protein therapeutics (e.g. SECHPLC icIEF Karl Fischer titration viscometers fluorescence DSC UVVis).
Strong statistical data analysis skills including DoE experience (Minitab JMP).
Ability to work independently troubleshoot complex challenges and drive projects forward.
Experience with process modeling and scientific programming is a plus.
Additional Information :
All your information will be kept confidential according to EEO guidelines.