Scientist, Biology-Discovery Full-time NEW

Formulation Scientist

We are seeking a highly motivated and skilled scientist to join our team in the formulation development and stability testing of therapeutic monoclonal antibodies and related biologics. This hands-on, laboratory-based role is responsible for designing and developing robust, scalable, and stable formulations to support product development and regulatory submissions. The successful candidate will lead execution of formulation screening and stability studies while collaborating cross-functionally with process development, analytical, and manufacturing teams.

Key Responsibilities:

• Design and execute experiments to screen excipients and stabilizers for liquid formulations of monoclonal antibodies.
• Develop formulations by selecting appropriate excipients, buffers, surfactants, pH conditions, and other components based on the physicochemical properties of the antibody product.
• Optimize formulations through data-driven iteration to achieve desired stability and performance.
• Plan and conduct accelerated stability studies, including stress and forced degradation testing, to evaluate formulation robustness and understand degradation pathways.
• Perform real-time and accelerated stability testing across various stages of product development (e.g., BDS, DP, reference standards, intermediates).
• Utilize analytical and biophysical techniques for protein characterization and stability assessment, including but not limited to HPLC/UPLC, CE, DLS, DSC, and spectrometry.
• Author technical reports and study protocols. Maintain accurate and detailed records in electronic laboratory notebooks.
• Conduct routine laboratory work and maintain laboratory equipment.
• Present experimental findings and project updates to internal teams and stakeholders.
• Collaborate with internal teams to assess protein quality and support analytical needs across departments.
• Work cross-functionally with teams in process development, analytical sciences, and manufacturing.

Qualifications:

Education:

• Bachelor's degree in Pharmaceutical Sciences, Biochemistry, Chemistry, Chemical Engineering, or a related discipline required.
• Master's degree in Pharmaceutical Sciences, Biochemistry, Chemistry, Chemical Engineering, or a related discipline preferred.

Required Experience and Skills:

• Minimum of 5 years of experience in formulation development of recombinant proteins.
• Hands-on experience in developing liquid formulations for biologics, particularly monoclonal antibodies or antibody-like products.
• Proficiency in designing and executing real-time and accelerated stability studies.
• Strong technical expertise in analytical and biophysical characterization techniques (e.g., HPLC/UPLC, CE, DLS, DSC).
• Excellent problem-solving, communication, and teamwork skills.
• Ability to work independently and manage multiple projects in a fast-paced environment.

Preferred Experience and Skills:

• 3–5 years of experience in antibody therapeutic discovery or development.
• Deep understanding of protein chemistry, degradation mechanisms, and stabilization strategies.
• Experience in formulation development across diverse therapeutic areas.
• Familiarity with high-throughput formulation screening approaches.
• Experience in forced degradation studies and defining critical quality attributes (CQAs) from stability data.
• Knowledge of regulatory guidelines and requirements for biologics formulation and stability testing.