Senior Scientist, Analytical Research and Development – Onsite Full-time

Senior Scientist

The Materials and Biophysical Characterization group in Analytical Research and Development is seeking a highly self-motivated and innovative scientist with deep knowledge and problem-solving skills in biotherapeutics characterization. The Materials and Biophysical Characterization team is responsible for building the mechanistic understanding of the interplay between formulation composition, stability, device, and process to ensure robustness and quality of drug substances and drug products in the biotherapeutics pipeline.

As a Senior Scientist, you will be contributing to projects in a diverse biotherapeutics pipeline by developing and implementing biophysical and particle characterization assays and collaborating with process, formulation and device functions as part of the CMC development team. You are expected to use your scientific expertise to find creative solutions to challenging problems which require deep analytical insight and critical thinking. Additional responsibilities include authoring technical reports and regulatory documents, presenting technical data, and project management. You will have the opportunity to conduct independent research, publish research findings, present at scientific conferences, and engage with various external scientific societies/organizations. This is an excellent growth and learning opportunity to work in an exciting, collaborative environment with a wide array of scientists from different divisions and make significant contributions towards our life-saving medicines.

Education Minimum Requirement:

• Ph.D. in Biophysics, Biochemistry, Chemistry, Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline
• OR M.S. in Biophysics, Biochemistry, Chemistry, Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum 4 years of relevant industry experience.

Required Experience and Skills:

• Experience in the analysis of biologics, protein/peptide stability, protein-protein interactions
• Experience with subvisible and submicron particle characterization tools (e.g. flow imaging microscopy, backgrounded membrane imaging (BMI), flow cytometry, dynamic light scattering (DLS))
• Hands-on experience in biophysical characterization of proteins and peptides (e.g. Circular Dichroism (CD), Infrared Spectroscopy (IR), Differential Scanning Calorimetry (DSC), Analytical Ultracentrifugation (AUC))
• Understanding of protein aggregation mechanisms and link between analytical methodologies for analysis
• Ability to deliver complex objectives under aggressive timelines in a rapidly changing environment
• Demonstrated ability for taking initiative, creativity, and innovative problem solving.
• A strong team player with excellent oral and written communication skills; ability to work both independently and cross-functionally

Desired Experience and Skills:

• Experience with characterization of lyophilized protein formulations
• Experience with Small Angle Xray Scattering
• Experience with molecular modeling.
• Experience with biological formulation development and analytical method development.
• Experience with various biologics modalities including peptides, mAbs, ADC, fusion proteins

Required Skills:

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