Scientist III - Katalyst CRO : Job Details

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Job SummaryProduct Development Science and Technology (PDS&T) is seeking a motivated Scientist to support parenteral drug product process development, scale-up, and technology transfer to commercial manufacturing sites. This role will focus on the development of robust manufacturing processes for clinical and commercial-phase products, with an emphasis on antibody-drug conjugates (ADCs).

Job SummaryProduct Development Science and Technology (PDS&T) is seeking a motivated Scientist to support parenteral drug product process development, scale-up, and technology transfer to commercial manufacturing sites. This role will focus on the development of robust manufacturing processes for clinical and commercial-phase products, with an emphasis on antibody-drug conjugates (ADCs).The Scientist will independently design and execute laboratory studies, generate and analyze precise and reproducible data, and contribute to cross-functional product development and Chemistry, Manufacturing, and Controls (CMC) teams.Responsibilities

• Design and execute studies to develop and optimize manufacturing processes for parenteral drug products.
• Conduct stability assessments of biologics by evaluating their chemical and physical properties under various conditions, including pH, ionic strength, temperature, light, and moisture exposure.
• Assess the impact of manufacturing process stresses (e.g., freeze-thaw cycles, mixing, filtration, filling, and lyophilization) on product stability and performance.
• Interpret experimental results, identify significant deviations, and propose and execute follow-up studies to refine process parameters.
• Support scale-up activities and technology transfer to commercial manufacturing sites.
• Prepare technical reports, regulatory documentation, and presentations to communicate findings effectively.

Requirements:

• Bachelor's degree in chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field with 7+ years of relevant experience. OR
• Master's degree with 3+ years of experience. OR
• PhD with 0+ years of experience.
• Strong background in parenteral drug product development, particularly ADCs.
• Experience with formulation stability studies and analytical techniques for biologics.
• Demonstrated ability to analyze data, troubleshoot experiments, and optimize processes.
• Excellent scientific writing and verbal communication skills.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionResearch, Analyst, and Information Technology

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