Scientist, Analytical Development
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 expertise in protein analytics. 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: Develop new and optimize existing analytical test methods for the characterization of Seqirus products. Qualify developed test methods to demonstrate their robustness and suitability for future validation and GMP use. Search the scientific literature and apply innovative experimental strategies to expand and enhance analytical capabilities for the characterization of Seqirus products. Design and execute 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 5 years of related experience; M.S. degree and 3 years of related experience; Ph.D. degree and 0-1 year of related experience in Biophysics, Biochemistry, Analytical Chemistry.
- Possesses theoretical background in protein biochemistry/biophysics from academic and/or industry settings.
- Demonstrate expertise 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
- Ability to work independently and collaboratively in a fast-paced environment.
Responsibilities
- Develop new and optimize existing analytical test methods for the characterization of Seqirus products.
- Qualify developed test methods to demonstrate their robustness and suitability for future validation and GMP use.
- Search the scientific literature and apply innovative experimental strategies to expand and enhance analytical capabilities for the characterization of Seqirus products.
- Design and execute 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Ph.D. or professional degree
Number of Employees
1,001-5,000 employees
