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