Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Job Summary:
Product 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.