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Job Location drjobs

Antioch, TN - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

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.


Remote Work :

No


Employment Type :

Contract

Employment Type

Contract

Company Industry

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