Job Title: Senior Scientist, Formulation - Biologics
Job Overview:
We are seeking a highly skilled and motivated Senior Scientist to join our Formulation Development team, focused on the development of Biologics including mAbs, ADCs, and fusion proteins. The ideal candidate will hold a PhD in a relevant scientific discipline, with a minimum of 2 years of industry experience in Biologics formulation. In this role, the Senior Scientist will be responsible for the design, optimization, and scale-up of protein formulations, stability studies, and drug product development for Biologic therapeutics.
Key Responsibilities:
- Lead formulation development efforts for biologics, including monoclonal antibodies (mAbs), ADCs, and fusion proteins, focusing on stability, solubility, and compatibility with various delivery systems.
- Design, execute, and analyze experiments to optimize protein formulations, including buffer selection, excipient compatibility, and process conditions.
- Conduct stability testing under accelerated, real-time, and stress conditions to assess formulation integrity, stability, and compatibility.
- Work closely with cross-functional teams, including Analytical Development, Process Development, and Quality Control, to ensure alignment and consistency of formulations through the product development lifecycle.
- Drive the development of scalable and robust formulations for clinical and commercial manufacturing, ensuring compatibility with large-scale production methods.
- Provide scientific leadership in the resolution of complex formulation challenges during early and late-stage development.
- Author technical documentation, including formulation protocols, study reports, and data analysis for internal and regulatory submissions.
- Stay current with scientific trends and industry developments related to biologics formulation, particularly in the areas of mAbs, ADCs, and fusion proteins.
- Mentor and guide junior scientists and associates in formulation development best practices.
Qualifications:
- PhD in Biochemistry, Molecular Biology, Chemical Engineering, Pharmaceutical Sciences, or a related field.
- Minimum of 2 years of industry experience in biologics formulation, with expertise in monoclonal antibodies (mAbs), ADCs, fusion proteins, or other protein-based therapeutics.
- Strong understanding of protein chemistry, stability, and formulation strategies.
- Proficiency in analytical techniques used for protein characterization and stability assessment (e.g., HPLC, SEC, DSC, DLS, FTIR, UV-Vis, etc.).
- Experience in conducting stability studies and interpreting data to assess shelf life, degradation pathways, and formulation performance.
- Familiarity with biopharmaceutical manufacturing processes, scale-up, and cGMP requirements.
- Ability to troubleshoot complex formulation issues and collaborate with cross-functional teams.
- Excellent written and verbal communication skills, with the ability to present complex data to internal and external stakeholders.
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