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$120k–$180k/yr
Full-time
postgraduate degree
Competitive Benefits, Professional Development Opportunities
Posted 36d ago
~40 hrs/week
Responsibilities
Lead the development of small molecule drug products, focusing on formulation, process development, and manufacturing support for medical countermeasures. Provide strategic technical leadership to ensure resilient pharmaceutical supply chains and support U.S. government national security needs.
Requirements
Requires an MS with 5 years of experience or a PhD with 3 years of experience in Pharmaceutical Sciences or a related field. Candidates must have expertise in small molecule development, knowledge of cGMP/FDA regulations, and be U.S. citizens eligible for a Secret security clearance.
Full job description
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.
Roles & Responsibilities:
We are seeking an experienced Senior Pharmaceutical Scientist to lead the development of small molecule drug products supporting advanced research, development, manufacturing, and lifecycle management activities. This role will provide technical and strategic leadership across formulation development, process development, analytical characterization, manufacturing support, and supply chain resilience for orally delivered, injectable, topical, or other small molecule prophylactic and therapeutic products. The ideal candidate will bring expertise in small molecule pharmaceutical development and experience supporting Medical Countermeasures programs aligned with the mission needs of the U.S. Government, including candidate assessment, preclinical development, clinical-stage development (including under the animal rule), manufacturing, and transition to sustainment of products intended to address operational, emergency preparedness, and national security requirements.
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
Basic 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
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.
This position requires a minimum of 50% hybrid on-site
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
This requisition requires the candidate to have a minimum of the following clearance(s):
None
This requisition requires the hired candidate to have or obtain, within one year from the date of hire, the following clearance(s):
Secret
Salary compensation range and midpoint:
$119,500 - $149,500 - $179,500 Annual
Work Location Type:
Hybrid
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Commitment to Non-Discrimination
All qualified applicants will receive consideration for employment without regard to disability, status as a protected veteran or any other status protected by applicable federal, state, local or international law.
MITRE intends to maintain a website that is fully accessible to all individuals. If you are unable to search or apply for jobs and would like to request a reasonable accommodation for any part of MITRE’s employment process, please email [email protected] for general support and [email protected] for intern positions. This service is for individuals requiring reasonable accommodation requests. Please note that vendor solicitations will not receive a reply.
Small MoleculePharmaceutical SciencesMedicinal ChemistryChemical EngineeringPharmaceuticsMedical CountermeasuresCMCcGMPGLPFDAICH GuidelinesINDNDARegulatory Affairs CertificationRACTechnology Transfer
MITRE is a nonprofit systems engineering, applied research, and advanced technology organization. We’re a leader in federally funded research, delivering deep technical integration, developing rapid prototypes, and innovating in the public interest.
We serve as a force multiplier across multiple U.S. government agencies to bring together the right technologies and partners. Addressing complex mission challenges, we strengthen our nation’s security, health, and prosperity.
Offices: 7515 Colshire Dr, McLean, VA 22102, US · 202 Burlington Rd, Bedford, MA 01730, US
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