Job Summary:
Product Development Science and Technology (PDS&T) is seeking a motivated Scientist to support parenteral drug product process development scaleup and technology transfer to commercial manufacturing sites. This role will focus on the development of robust manufacturing processes for clinical and commercialphase products with an emphasis on antibodydrug conjugates (ADCs).
The Scientist will independently design and execute laboratory studies generate and analyze precise and reproducible data and contribute to crossfunctional 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. freezethaw cycles mixing filtration filling and lyophilization) on product stability and performance.
- Interpret experimental results identify significant deviations and propose and execute followup studies to refine process parameters.
- Support scaleup activities and technology transfer to commercial manufacturing sites.
- Prepare technical reports regulatory documentation and presentations to communicate findings effectively.
Requirements:
- Bachelors degree in chemistry Chemical Engineering Pharmaceutical Sciences or a related field with 7 years of relevant experience. OR
- Masters 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.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract