Associate Principal Scientist, Materials and Biophysical Characterization

Associate Principal Scientist

The Materials and Biophysical Characterization group in the Pharmaceutical Analysis and Digital Technologies organization 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 an Associate Principal Scientist, you will be contributing to projects in a diverse biotherapeutics pipeline by developing and implementing biophysical and particle characterization tools 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 with a minimum of 4 years of relevant industry experience.
• OR
• M.S. in Biophysics, Biochemistry, Chemistry, Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 8 years of relevant industry experience.

Required

Experience and Skills:

• 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))
• 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, back grounded membrane imaging (BMI), flow cytometry, dynamic light scattering (DLS))
• Experience with biological formulation development and analytical method development.
• 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 characterization of protein-interface interactions (e.g. interfacial rheology, QCMD)
• Experience with characterization of combination products for protein therapeutic delivery (e.g. autoinjectors)
• Experience with molecular modeling.
• Experience with various biologics modalities including peptides, mAbs, ADC, fusion proteins

Required Skills:

Biomedical Engineering, Biophysics, Chemical Engineering, Circular Dichroism (CD), Differential Scanning Calorimetry (DSC), Infrared Spectroscopy, Pharmaceutical Sciences, Protein Analysis, Protein Interactions, Spectrophotometry, Spectroscopy, Technical Data Analysis

Preferred

Skills:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

The salary range for this role is $ - $. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful…