Scientist IV, Pharmaceutical 3DP and Custom Formulation

Job Details

Description

Who is USP?

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide.

At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

Brief Job Overview

USP’s Advanced Manufacturing Technologies (AMT) team advances practical approaches for making and testing medicines in new ways. A major focus is desktop and distributed pharmaceutical 3D printing for nonsterile compounding, including the preparation of customized and patient-centered dosage forms closer to the point of care. The Scientist IV, Pharmaceutical 3DP & Custom Formulation is a senior individual contributor who applies compounding pharmacy practice and pharmaceutical formulation science to design, produce, and evaluate 3D-printed and conventionally manufactured dosage forms.

The position is expected to spend at least 50% of its time performing hands-on laboratory work in USP’s Rockville Advanced Technologies Laboratory, including operation of desktop pharmaceutical 3D-printing systems and supporting formulation and analytical instruments. The Scientist will lead technical work across internally funded projects conducted with Healthcare Quality and Safety (HQS), General Chapters, and other USP teams, as well as externally funded research and client projects. If the ARPA-H FASTPaSS project is awarded to USP, the role will support formulation, sample-production, and other activities within that program.

How will YOU create impact here at USP?

As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.

Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.

The Scientist IV, Pharmaceutical 3DP & Custom Formulation has the following responsibilities:

50% – Compounding-focused laboratory research, formulation development, and production

• Independently design and execute pharmaceutical compounding, formulation, and process-development studies using desktop 3D-printing platforms and other laboratory equipment.
• Develop, optimize, compound, and prepare customized and patient-centered dosage forms, printable formulations, pharmaceutical inks, feedstocks, conventional tablet comparators, and challenge materials for non-GMP research use.
• Operate, maintain, troubleshoot, and document use of 3DP equipment and relevant supporting instruments in accordance with laboratory procedures and safety expectations.
• Apply Quality by Design (QbD), design of experiments (DoE), risk assessment, and sound formulation science to evaluate relationships among material attributes, process parameters, dosage-form design, and product performance.
• Plan and conduct testing of raw materials, in-process materials, and finished dosage forms, including physical characterization, assay/content, content uniformity, disintegration, dissolution, friability, hardness/breaking force, moisture, and other fit-for-purpose tests as applicable.
• Generate traceable research data and maintain complete laboratory notebooks, electronic records, sample inventories, instrument records, and study documentation.

20% – Scientific leadership and project execution

• Serve as a technical subject-matter expert in nonsterile pharmaceutical compounding, desktop and distributed pharmaceutical 3D printing, formulation development, and custom dosage-form design.
• Lead defined technical work packages from study design and protocol development through execution, data analysis, interpretation, reporting, and closeout.
• Establish experimental plans, milestones, resource needs, technical risks, and acceptance criteria; communicate issues early and recommend practical corrective actions.
• Author or contribute to protocols, study plans, methods, SOPs, technical reports, manuscripts, conference materials, proposals, scopes of work, and funder or client deliverables.
• Ensure externally funded work is scientifically rigorous, delivered on schedule, and consistent with agreed scope, quality, confidentiality, and documentation requirements.

20% – Cross-USP and external collaboration

• Partner with HQS, General Chapters, compounding pharmacy stakeholders, analytical science, reference standards, and other USP teams to translate stakeholder needs into executable laboratory studies and useful scientific outputs.
• Work with pharmaceutical companies, children’s research hospitals, pharmacies, academic collaborators, technology providers, government agencies, and other stakeholders on sponsored and collaborative projects.
• Contribute technical content to funding proposals and support technical discussions with prospective sponsors and partners.
• If ARPA-H FASTPaSS is awarded to USP, support approved project activities involving formulation, production of representative or challenge samples, reference-truth testing, method execution, and technical documentation.

10% – Laboratory capability, quality, and knowledge building

• Help establish and improve laboratory workflows, fit-for-purpose methods, equipment qualification and maintenance practices, material controls, cleaning approaches, and safe operating procedures for 3DP and custom formulation work.
• Review scientific literature, emerging technologies, standards, and stakeholder input to identify research needs and opportunities for USP guidance, standards, training, or services.
• Mentor or train colleagues, interns, contractors, or project participants in relevant methods and laboratory practices without formal supervisory responsibility.
• Present scientific findings internally and externally and contribute to peer-reviewed or other appropriate dissemination of results.
• Other duties and projects assigned.

Who is USP Looking For?

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the competencies and experience below.

• Ph.D. with substantial hands-on experience in pharmaceutical compounding, formulation development, dosage-form preparation, and applied laboratory research, plus at least three (3) years of relevant experience. A Ph.D. in pharmaceutical sciences, pharmaceutics, industrial pharmacy, chemistry, chemical engineering, biomedical engineering, or a closely related field with at least three (3) years of relevant experience may also qualify; a master’s degree in one of these fields with at least five (5) years of relevant experience may be considered. Alternative combinations of education and relevant experience may be considered.
• Hands-on experience in nonsterile pharmaceutical compounding, pharmaceutical formulation development, and preparation or production of customized solid oral or other relevant dosage forms.
• Hands-on experience with desktop or distributed pharmaceutical 3D printing, additive manufacturing, automated compounding, hot-melt extrusion, semi-solid extrusion, binder jetting, fused-deposition modeling, or closely related drug-product manufacturing technology.
• Experience performing common dosage-form tests such as assay, content uniformity, disintegration, dissolution, friability, hardness/breaking force, dimensional measurements, and moisture testing.
• Ability to independently design experiments, troubleshoot equipment and formulation problems, interpret multivariable data, and make defensible technical recommendations.
• Experience developing and documenting methods, protocols, SOPs, study reports, and laboratory records in a quality-conscious research or regulated environment.
• Knowledge of formulation science, excipient functionality, material characterization, critical material attributes, critical process parameters, and critical quality attributes.
• Strong written and verbal communication skills and demonstrated ability to work across scientific disciplines and organizational boundaries.
• Ability and willingness to perform hands-on laboratory work for at least 50% of working time and to work on-site in Rockville as required by laboratory schedules.
• Ability to safely handle pharmaceutical ingredients and use required personal protective equipment in a laboratory environment.

Additional Desired Preferences

• Current or prior pharmacist licensure and practice experience in compounding pharmacy, including nonsterile compounding and individualized dosage forms.
• Experience in pharmaceutical development, compounding, hospital pharmacy, an academic pharmaceutics laboratory, a contract research organization, or a pharmaceutical manufacturing environment.
• Experience with 503A or 503B compounding operations and familiarity with applicable USP compounding chapters and dosage-form performance chapters.
• Experience with pediatric, geriatric, personalized, modified-release, multi-drug, or patient-centered dosage forms.
• Experience with analytical instruments such as HPLC/UPLC, UV-Vis, NIR, Raman, FTIR, particle-size analysis, rheology, thermal analysis, microscopy, and/or imaging tools.
• Experience applying DoE, QbD, statistical analysis, process modeling, process analytical technology, or non-destructive/in-process testing.
• Experience contributing to externally sponsored research, customer-funded projects, government awards, proposals, or deliverables.
• Experience collaborating with standards-setting, regulatory, industry, academic, pharmacy-practice, or healthcare stakeholders.
• A record of scientific presentations, publications, technical reports, patents, or other evidence of scientific contribution..

Supervisory Responsibilities

None. This is an individual contributor role. The position may provide technical guidance, training, or mentorship to project staff, interns, contractors, or collaborators.

Benefits

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

Compensation:

Base Salary Range: USD $ 86,860 – $117,018.00 annually.

Target Annual Bonus: % Varies based on level of role.

Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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