Website Karwell Technologies
Karwell Technologies
Company : Karwell Technologies
Job Description:
- 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 analyse 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 analyse data, troubleshoot experiments, and optimize processes.
- Excellent scientific writing and verbal communication skills.