Scientist IV-V Reference Standards Laboratory (1039-679)
This is a key hands-on, leadership position in USP’s Reference Standards Laboratory. In this role, the Scientist IV/V shares technical responsibility for scientists conducting routine, non-routine, and investigative analyses of candidate reference materials and samples by appropriate analytical methods as part of USP’s collaborative testing program. The Scientist IV/V will work closely with the team members, provide technical oversight and solve technical problems, review data, and generate reports. They will also serve as the point of contact with Reference Standard Scientists for questions and comments. In addition, the incumbent is responsible for ensuring full utilization of assigned staff members, working closely with their supervisor to manage workloads. The Scientist IV/V provides input into the performance reviews of team members and serves as a mentor for the Scientists. When appropriate, the incumbent works hands-on, resolving technical problems and/or conducts testing as necessary to support project work. This Scientist IV/V may execute up to 35% of their work at the bench level under highly variable timelines.
Roles and Responsibilities:
- Provides technical oversight to assigned team of scientists, including assignment of tests, providing technical support, reviewing of data, and generating and issuing reports.
- Provides administrative oversight by ensuring full utilization of assigned staff, and through participation in the performance review process.
- Provides technical review support for the reference standard testing reports.
- Serve as a lead for specialty projects (example: Mass spectroscopy projects)
- Provides project and technical support within RSL, including managing project tasks via interacting with clients on activities related to the evaluation of candidate reference materials, investigative studies, and collaborating with RSL leaders, other departments, and/or customers to create an achievable work schedule within a defined response time.
- Participates in cross-functional teams involved in Reference Material Development, including development of test protocols, stability protocols, and investigative studies.
- Serves as a mentor for scientists in the laboratory.
- Shares technical expertise with Team Leaders and serves as a technical adviser for them.
- Initiates and coordinates Lab Investigations and Deviations when necessary through applicable processes and endeavors to determine and resolve root cause to issues.
- Represents RSL in internal customer meetings to receive/deliver information, requests and requirements.
- Takes the lead in working with other departments within the organization to solve both technical and process-related issues.
- Prepares study reports and presents data internally within USP and externally to customers; serves as the technical lead for deviation investigation, customer complaints, out-of-specification or aberrant results and process changes; troubleshoots assay and instrumentation issues. This aspect will involve data mining, trending and investigative analysis to identify problems or determine process controls.
- Reviews, interprets, and evaluates scientific literature.
- Investigates, evaluates, and recommends the purchase of laboratory equipment.
- Attends scientific seminars and presents publications.
- Proficient with testing involving compendial methods for raw materials and API (USP, BP, EP, etc.). Expert in HPLC and HPLC-MS (ThermoOrbitrap Elite and Waters Synapt G2-S HDMS /Maldi), GC, and GC-MS; proficient in other related analytical instrumentation (e.g., FTIR, ICP, TGA, DSC, XRD).
- Highly proficient in troubleshooting of various analytical methods; demonstrated ability to suggest alternative testing designs.
- Proficient in data and/or project reports review required.
- Ph.D. in science and 5 years of relevant laboratory experience; or MS in Science and 7 years of relevant laboratory experience.
- Ph.D. in Science and 8 years of relevant laboratory experience, or MS in Science and 10 years of relevant laboratory experience.
- Possesses experience and a proven track record of introducing new or innovative technologies to the laboratory.
- Proficient in project management with focus on evolving priorities and tasking resources to meet them.
- Excellent communication and presentation skills, both verbal and written.
- Demonstrate the ability to lead a team of scientists in bringing projects to completion with a high degree of scientific expertise.
- Highly proficient in method development/validation.
- Takes personal responsibility to ensure work is delivered on time and meets highest possible standards of quality.
- Demonstrates strong skills in anticipating, troubleshooting, and solving technical problems.
- Plans and conducts research projects independently and has the ability to build technical expertise in others by serving as a role model and mentor.
USP offers an impressive benefits package, including:
- Generous paid time off – 13 paid holidays, 10 sick days and 15 vacation days per year to start
- An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately
- Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles ($250/individual or $500/family)
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
Being a part of USP means belonging to a diverse culture made up of more than 1,000 talented professionals working together at five international locations. We share our expertise in science, IT, human resources, quality assurance, communications, administrative management, and more...all to support an overall mission dedicated to making a difference by providing standards and programs that help improve the quality of medicines, dietary supplements, and foods worldwide.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
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.Job Location Rockville, Maryland, United States Position Type Full-Time/Regular