Senior Biopharmaceutical Scientist

About the role

The Biotechnology and Life Sciences Department at MITRE is dedicated to advancing pharmaceutical solutions that support U.S. defense and public health preparedness objectives. We provide technical expertise to accelerate the delivery of safe, effective Medical Countermeasures and ensure resilient pharmaceutical supply chains.

Responsibilities

• Lead the development of small molecule drug products supporting advanced research, development, manufacturing, and lifecycle management activities.
• Provide technical and strategic leadership across formulation development, process development, analytical characterization, manufacturing support, and supply chain resilience for various dosage forms.
• Support development of pharmaceutical products intended to meet Medical Countermeasures needs of the U.S. Department of Defense, including force health protection, emergency response, and operational readiness.
• Investigate supply chain dependencies, bottlenecks, and chokepoints to inform U.S. strategies and programs to establish and sustain resilient pharmaceutical supply chains.
• Collaborate with cross-functional teams in R&D, manufacturing, quality, regulatory, clinical, and program management to advance small molecule development programs.
• Identify, assess, and develop mitigation strategies for technical, business, and programmatic risks to medical countermeasure development.
• Analyze complex data to support formulation selection, process robustness, product quality, and shelf-life determination.
• Support scale-up, process transfer, and manufacturing readiness activities for pilot, clinical, and commercial production.
• Ensure work is conducted in compliance with applicable regulatory and quality standards, including cGMP, GLP, FDA regulations and guidance, and ICH guidelines.
• Monitor scientific, regulatory, and industry trends relevant to small molecule therapeutics, pharmaceutical technologies, and defense-focused Medical Countermeasures programs.
• Act as a trusted advisor to U.S. Government sponsors.

Qualifications

• MS + 5 years of experience or Ph.D. +3 years of experience in Pharmaceutical Sciences, Chemistry, Medicinal Chemistry, Chemical Engineering, Pharmaceutics, or related scientific field.
• 3-5 years of experience in small molecule pharmaceutical development, drug product development, or related CMC functions.
• Strong expertise in formulation development, preformulation, analytical characterization, and process development for small molecule products.
• Demonstrated experience leading complex development programs and working across multidisciplinary teams.
• Strong understanding of cGMP, FDA regulatory expectations, ICH guidelines, and pharmaceutical quality systems.
• Excellent technical writing, data interpretation, problem-solving, and communication skills.
• Eligibility for a collateral Secret security clearance.

Preferred Qualifications

• Experience supporting chemical, biological, radiological, or nuclear defense, epidemic response, or emergency preparedness medical countermeasure development programs.
• Experience with government-sponsored development environments, including collaboration with defense, public health, or federal R&D stakeholders.
• Experience supporting IND, NDA, or other regulatory submissions.
• Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).
• Knowledge of technology transfer, process validation, and manufacturing support in a regulated environment.
• Experience with rapid development timelines, product shelf-life extension strategies, or deployment-oriented pharmaceutical requirements.
• Ability to work effectively in a fast-paced, matrixed, mission-driven environment.