Senior Biopharmaceutical Scientist

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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

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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.

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