What are the responsibilities and job description for the Formulation Scientist – Injectable Drug Product Development position at Katalyst?
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 SEC-HPLC, icIEF, Karl Fischer titration, viscometers, fluorescence, DSC, and UV-Vis 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 scale-up.
- Independently troubleshoot formulation and process development challenges, analyzing data and providing recommendations.
- Collaborate with cross-functional teams, including analytical, regulatory, quality, and manufacturing groups to ensure successful product development.
- Author technical reports, regulatory documents, and presentations to communicate findings and support regulatory submissions.
Required Qualifications:
- Level II: BS with 4-6 years of relevant industry experience, or MS with 0-3 years of experience.
- Level III: MS or PhD with 5 years of industry experience.
- Hands-on 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., SEC-HPLC, icIEF, Karl Fischer titration, viscometers, fluorescence, DSC, UV-Vis).
- 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.
Job Type: Contract
Pay: $35.00 - $40.00 per hour
Schedule:
- Monday to Friday
Work Location: In person
Salary : $35 - $40
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