Senior Research Associate/ Scientist, Drug Product Process Development and Manufacturing

Responsibilities

• Perform hands-on formulation and drug product process development for mRNA-LNP therapeutics, with additional involvement in AAV gene therapy and protein drug product development.
• Design and execute experiments to develop stable and effective drug product formulations, including excipient selection, concentration optimization, and compatibility studies.
• Build internal drug product process development capabilities and produce materials to supply non-clinical studies.
• Develop and scale up drug product manufacturing processes, considering critical process parameters (CPPs) and critical quality attributes (CQAs).
• Apply statistical analysis and experimental design to optimize process parameters and maximize product yield and quality.
• Conduct stability testing to assess the long-term integrity of drug products under various storage conditions and identify potential degradation pathways.
• Collaborate with Contract Development and Manufacturing Organizations (CDMOs) to optimize and improve drug product manufacturing processes, support scale-up, and contribute to in-process control strategies.
• Provide technical support for Good Manufacturing Practices (GMP) manufacturing activities, including document review.
• Maintain accurate laboratory records, document experimental protocols and results, and contribute to development reports and regulatory submissions.
• Stay current with industry trends, emerging technologies, and regulatory guidelines to support continuous process improvement and compliance.
• Actively contribute to a team culture of continuous improvement, ownership, professional growth, and inclusion.

Qualifications

• Scientist Level Requirement: Ph.D. in chemical engineering, biochemical engineering, biotechnology, pharmaceutical sciences, or a related field with 2–3 years of relevant industry experience.
• Senior Research Associate Requirement: Master’s degree in a related discipline with a minimum of 6 years of relevant industry experience in drug product process development.
• Hands-on experience with mRNA-LNP formulation and/or process development is strongly preferred.
• Experience with protein therapeutics and/or AAV gene therapy formulation development is a plus.
• Experience with formulation development, process optimization, and drug product development.
• Understanding of the physical and chemical stability of biologics and how process-related stresses impact product quality.
• Strong problem-solving skills with the ability to independently design experiments, interpret complex data sets, and communicate findings clearly.
• Ability to thrive in a dynamic, fast-paced environment, adapting readily to shifting priorities with a willingness to develop new technical skills and to work across multiple therapeutic modalities.
• Excellent written and verbal communication skills; ability to collaborate effectively in a diverse, global, cross-functional organization and a commitment to diversity, equity, and belonging.