Associate Principal Scientist - Analytical Development
Catalent
Catalent seeks an Associate Principal Scientist in Analytical Development to lead method development and characterization for biologics and advanced therapeutics. This technical leadership role requires expertise in analytical techniques and will involve scientific oversight of complex client programs, regulatory support, and team mentorship.
Responsibilities
- Lead analytical method development, optimization, qualification, and validation for biologics programs
- Serve as subject matter expert providing scientific guidance to internal teams and external clients
- Design and execute analytical studies applying AQbD and DoE methodologies
- Support characterization strategies for monoclonal antibodies, recombinant proteins, nucleic acids, and emerging modalities
- Mentor junior scientists and contribute to expanding departmental analytical capabilities
Requirements
- PhD in Biochemistry, Analytical Chemistry, Molecular Biology, Biotechnology, or related field with 6+ years experience; OR Master's with 10+ years; OR Bachelor's with 12+ years
- Hands-on proficiency with HPLC/UPLC, LC-MS, CE-SDS, or related chromatography and characterization methods
- Experience with method qualification, validation, and technology transfer
- Expertise in biologics analytical testing such as ELISA, potency assays, or nucleic acid characterization
- Strong technical report writing and regulatory documentation skills
- Demonstrated ability to apply Analytical Quality by Design and Design of Experiments principles
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