Scientist IV, Pharmaceutical 3DP and Custom Formulation

USP•Rockville, MD

1d•Onsite

About The Position

USP’s Advanced Manufacturing Technologies team advances practical approaches to making and testing medicines, with a focus on desktop and distributed pharmaceutical 3D printing for nonsterile compounding and customized, patient-centered dosage forms. The Scientist IV 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. At least 50% of the role is hands-on laboratory work in USP’s Rockville Advanced Technologies Laboratory, including operating desktop pharmaceutical 3D-printing systems and supporting formulation and analytical instruments. The role leads technical work across internally funded projects with Healthcare Quality and Safety, General Chapters, and other USP teams, as well as external research and client projects. If USP is awarded the ARPA-H FASTPaSS project, the Scientist will support formulation, sample production, and related program activities. The position also builds laboratory capabilities, collaborates with internal and external stakeholders, and contributes to scientific reports and other research outputs. This is an individual-contributor role with no formal supervisory responsibilities, though it may provide technical guidance, training, or mentorship.

Requirements

Ph.D. with substantial hands-on experience in pharmaceutical compounding, formulation development, dosage-form preparation, and applied laboratory research, plus at least 3 years of relevant experience; or a Ph.D. in a relevant field with at least 3 years of relevant experience; or a master’s degree in a relevant field with at least 5 years of relevant experience. Alternative combinations of education and relevant experience may be considered.
Relevant fields include pharmaceutical sciences, pharmaceutics, industrial pharmacy, chemistry, chemical engineering, biomedical engineering, or a closely related field.
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.
Demonstrated understanding of USP’s mission and commitment to excellence through inclusive and equitable behaviors and practices, and ability to build credibility with stakeholders.

Nice To Haves

Current or prior pharmacist licensure and compounding pharmacy practice experience, 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, 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.
Scientific presentations, publications, technical reports, patents, or other evidence of scientific contribution.

Responsibilities

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 3D-printing equipment and supporting instruments in accordance with laboratory procedures and safety expectations.
Apply Quality by Design, design of experiments, risk assessment, and formulation science to evaluate relationships among material attributes, process parameters, dosage-form design, and product performance.
Plan and conduct fit-for-purpose testing of raw materials, in-process materials, and finished dosage forms, including physical characterization, assay/content, content uniformity, disintegration, dissolution, friability, hardness/breaking force, and moisture testing.
Generate traceable research data and maintain laboratory notebooks, electronic records, sample inventories, instrument records, and study documentation.
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 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 and recommend 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, on schedule, and consistent with scope, quality, confidentiality, and documentation requirements.
Partner with USP teams and stakeholders to translate needs into executable laboratory studies and useful scientific outputs.
Collaborate 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 the ARPA-H FASTPaSS project is awarded to USP, support approved activities involving formulation, representative or challenge-sample production, reference-truth testing, method execution, and technical documentation.
Help establish and improve laboratory workflows, fit-for-purpose methods, equipment qualification and maintenance practices, material controls, cleaning approaches, and safe operating procedures.
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.
Perform other assigned duties and projects.