Sr. Scientist - Analytical Development (Chromatography)

Job Summary:

The successful candidate will develop and manage chromatographic, electrophoretic and other relevant methods for the characterization and lot release of biopharmaceutical product candidates. The Senior Scientist will independently develop and qualify analytical methods to both characterize and lot release of biologics. The Senior Scientist will also effectively manage a small team of Scientists and Research Associates to carry out method development, biochemical and biophysical characterization of biologics, stability assessment, pre-formulation and formulation process development, optimization, and troubleshooting. The candidate must actively assist the biological analytical development group to communicate analytical data across multiple functional areas including analytical and formulation development, project management, and manufacturing.

The ideal candidate should have the following qualifications:

• Job Requirements: Ph.D. in Chemistry / Biochemistry or in related field with 5-8+ yrs. (or masters / bachelor degree in relevant field with 8-12+ yrs.) of relevant experience in analytical method development and structural characterization of biologics supporting CMC sections for IND, IMPD/CTA, and BLA submissions
• 2+ years of demonstrated team leadership of Research Associates / Scientists as well as project management
• Essential hands-on experience and in-depth knowledge of state-of-the-art instrumentation and modern analytical techniques (e.g., mass spectroscopy, peptide mapping, post-translational modification analysis including glycosylation/oligosaccharide characterization, HPLC, capillary electrophoresis, fluorescence spectroscopy, circular dichroism, light scattering, process residuals, and Compendial assays)
• Extensive experience with characterization of biologics (including process- & product-impurities/degradation product characterization), method development/qualification/validation, and tech transfer supporting early and late-stage development for proteins/peptides, monoclonal antibodies, protein conjugates (e.g., pegylation, etc.), antibody-drug conjugates, vaccines, etc.
• Clear understanding of formulation development and stability studies as well as upstream/downstream processing is desired
• Familiarity with cGMP-compliance and Quality/Regulatory Affairs, including a clear understanding of phase-appropriate CMC regulatory requirements is preferred
• Demonstrated ability to set clear and measurable goals for staff and prioritize tasks and resources to achieve superior work quality and efficiency
• Excellent presentation, oral and written communication skills, be able to communicate effectively to senior management, cross-functional teams, and collaborators/partners

Roles and Responsibilities

• Mentor and manage scientists at M.Sc./PhD level
• Work with partners to support complex scientific projects
• Manage projects scope, budget, and timelines