Scientist III

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

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.

All your information will be kept confidential according to EEO guidelines.