Principal Scientist, Analytical Development

CSL•Holly Springs, NC

About The Position

The Opportunity: CSL Seqirus is seeking a skilled and motivated Analytical Scientist to join our Molecular Characterization and Analytical Development team in Holly Springs, NC. This role is ideal for scientist with deep expertise in protein analytics, and a strong team player with excellent oral and written communication skills. You will serve as a subject matter expert (SME), driving innovation and excellence in Technical Operations to support company programs from early development through commercialization. This position collaborates cross-functionally with multiple groups working on product development. The Role: Lead comprehensive analytical projects to characterize vaccine compounds, developing new analytical test methods, and optimizing existing ones. Design and evaluate all parameters required for test method qualification to ensure method robustness and suitability for future validation and GMP use. Transfer analytical test methods to Seqirus external partners and coordinate analyses conducted by third-party partners. Search the scientific literature and apply innovative experimental strategies to expand and enhance analytical capabilities for the characterization of Seqirus products. Design analytical experiments in support process development, MS&T, and AS&T teams. Generate high-quality documentation suitable for publication and regulatory review. Perform peer reviews of data and reports related to method development, qualification, and/or validation.

Requirements

B.S. degree and 10 years of related experience; M.S. degree and 7 years of related experience; Ph.D. degree and 5 years of related experience in Biophysics, Biochemistry, Analytical Chemistry.
Possesses a strong theoretical background in protein biochemistry/biophysics from academic and/or industry settings.
Possess strong working knowledge of pharmaceutical drug substance and drug product development.
Possess experience in managing outsourced analytical projects with CMO/CRO partners.
Solid experience in developing, qualification, and/or validation analytical methods for proteins and glycans characterization, such as HPLC/UPLC, Capillary Electrophoresis, Bio-Layer Interferometry, Immunoassays, and/or Mass Spectrometry.
Demonstrates strong experience in searching scientific literature and applying discovered insights to develop new methods and improve existing methods.
Excellent communication skills and ability to present complex data to diverse audiences.
Ability to work independently and collaboratively in a fast-paced environment.

Responsibilities

Lead comprehensive analytical projects to characterize vaccine compounds, developing new analytical test methods, and optimizing existing ones.
Design and evaluate all parameters required for test method qualification to ensure method robustness and suitability for future validation and GMP use.
Transfer analytical test methods to Seqirus external partners and coordinate analyses conducted by third-party partners.
Search the scientific literature and apply innovative experimental strategies to expand and enhance analytical capabilities for the characterization of Seqirus products.
Design analytical experiments in support process development, MS&T, and AS&T teams.
Generate high-quality documentation suitable for publication and regulatory review.
Perform peer reviews of data and reports related to method development, qualification, and/or validation.