Principal Scientist, BioPhysical

Serve as the Principal Scientist responsible for the development and execution of highly complex method development and characterization studies related to the testing, characterization, and analysis of glycoproteins/biotherapeutics using biophysical instrumentation and methodologies.

• Functioning independently as the Principal Scientist and technical expert on highly complex studies, develop, perform, and troubleshoot laboratory experiments, tests, and procedures within accepted regulatory compliance for the characterization and analysis of biotherapeutics through use of biophysical instrumentation and methodologies.
• Generate and finalize high quality method and study protocols for sponsor and internal method characterization and sample testing programs. Ensure that study protocols are amended to accurately reflect any changes in scope of work or deliverables, in a timely fashion.
• Function as the primary contact for the planning and execution of Sponsor interaction related to proposal management, research, and method development, and for the design, scheduling, conduct and reporting of studies.
• Provide oversight of laboratories and mentor and/or supervise scientific staff in the development and execution of studies to generate high quality scientific data within accepted regulatory compliance.
• Provide mentoring and technical guidance to resolve challenges in a timely fashion.
• Implement techniques to improve productivity, increase efficiencies and maintain laboratory state-of-the-art practices.
• Perform routine testing in techniques such as the following with a high degree of reliability, efficiency and accuracy

• Analytical Ultracentrifugation (AUC)
• Size Exclusion HPLC-MALLS (SEC-MALLS)
• Differential Scanning Calorimetry (DSC)
• Intrinsic Tryptophan Fluorescence (ITF)
• Fourier Transform Infrared (FTIR)
• Dynamic Light Scattering (DLS)
• Protein Binding via SPR-Biacore
• Circular Dichroism (CD)

• At least seven (7) years of relevant experience within a contract research, academic or pharmaceutical industry, including experience in the core competencies of characterization and analysis of biotherapeutics.
• An equivalent combination of education and experience with contract research or the pharmaceutical industry may be accepted as a satisfactory substitute for the specific education and experience listed above.

• Demonstrated knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred.
• Ability to work on problems of moderate scope where analysis of situation or data requires a review of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Demonstrated ability to operate typical laboratory equipment, specifically HPLC, AUC, DSC, FTIR, DLS, Spectrometers and other laboratory equipment required.
• Ability to handle multiple projects, prioritize work and meet deadlines within a cGMP environment.
• Capable of data interpretation of basic characterization and analysis of biotherapeutics (glycoproteins and peptides) using biophysical laboratory tools and methodologies.
• Capable of anticipating and recognizing potential problems.
• Demonstrated independent analytical and problem-solving abilities.
• Must possess excellent interpersonal skills to maintain communication across functional groups.
• Ability to collaborate effectively within a group environment.
• Able to communicate (verbal and written) effectively in a small group or one on one setting.
• Computer proficiency in MS Word, Excel, Outlook, instrumentation, and analysis software.
• Ability to understand and use internal software programs such as LIMS required.