Senior Biopharmaceutical Scientist

The MITRE Corporation•New Bedford, MA

3d•$119,500 - $179,500•Hybrid

About The Position

Why choose between doing meaningful work and having a fulfilling life? At MITRE, you can have both. That's because MITRE people are committed to tackling our nation's toughest challenges—and we're committed to the long-term well-being of our employees. MITRE is different from most technology companies. We are a not-for-profit corporation chartered to work for the public interest, with no commercial conflicts to influence what we do. The R&D centers we operate for the government create lasting impact in fields as diverse as cybersecurity, healthcare, aviation, defense, and enterprise transformation. We're making a difference every day—working for a safer, healthier, and more secure nation and world. Our workplace reflects our values. We offer competitive benefits, exceptional professional development opportunities for career growth, and a culture of innovation that embraces adaptability, collaboration, technical excellence, and people in partnership. If this sounds like the choice you want to make, then choose MITRE - and make a difference with us. Department Summary: MITREs Biotechnology and Life Sciences Department is a mission-focused scientific department dedicated to advancing pharmaceutical solutions that support U.S. defense and public health preparedness objectives. The department provides technical expertise accelerate the delivery of safe, effective Medical Countermeasures and ensure resilient pharmaceutical supply chains. Working across multidisciplinary teams, we support rapid development, technical problem-solving, and transition of drug products to meet operational, emergency response, and national security needs.

Requirements

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
Experience with one or more dosage forms such as oral solids, sterile injectables, liquids, semi-solids, or modified-release systems
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
Per the U.S. Government’s eligibility requirements, you must be a U.S Citizen to be considered for a security clearance.

Nice To Haves

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

Responsibilities

Develop and evaluate technical and programmatic strategies for developing small molecule pharmaceutical products from preformulation through clinical and commercial readiness
Provide subject matter expertise related to formulation development, excipient compatibility, process scale-up and optimization, stability, dissolution, bioavailability, manufacturability, quality, and analytical method development for small molecule drug candidates
Support development of pharmaceutical products intended to meet Medical Countermeasures needs of the U.S. Department of War, including products relevant to 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.
Provide technical leadership for drug product development activities involving tablets, capsules, suspensions, solutions, lyophilized products, injectables, or other small molecule dosage forms including combination products
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
Author and review technical reports, development plans, study protocols, specifications, validation documents, deviation investigations, and regulatory submission content
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
Serve as a trusted advisor to U.S. Government Sponsors.
Monitor scientific, regulatory, and industry trends relevant to small molecule therapeutics, pharmaceutical technologies, and defense-focused Medical Countermeasures programs