The successful candidate has experience in the analysis and characterization of biologics using one or more technologies such as chromatographic, electrophoretic, mass spectrometric, LC-MS, biophysical or biological methods. The Research Scientist will, independently or collaboratively, develop and qualify analytical methods to both characterize and lot release of biologics. The Research Scientist will also effectively mentor or manage a small team of Research Associates to carry out method development and characterization of biologics, stability assessment, pre-formulation and formulation process development, optimization, and troubleshooting using LC-MS and MS/MS. 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 1-5 yrs. (or master’s degree in relevant field with 5-8 yrs.) of relevant experience in analytical method development and structural characterization of biologics supporting CMC sections for IND, IMPD/CTA, and BLA submissions
- 1+ years of demonstrated leadership of mentoring Research Associates
- 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, UPLC, 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.
- 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
- Work with partners to support complex scientific projects
- Manage projects scope, budget, and timelines
- Manage and maintain analytical instruments along with troubleshoot the instrument problems
- Develop analytical methods to characterize biologics
- Ability to conceptualize, develop and implement new mass methods to characterize biologics using mass spectrometry