Scientist IV/V (869-679)
This is a hands-on, non-supervisory position in USP’s Biologics & Biotechnology (B&B) Laboratory. In this role, the scientist delivers sustained contributions that result in innovative product and process technologies for USP. The scientist will contribute to the scientific expertise and work ethic of the laboratory through a broad range of technical knowledge. The scientist will have mastered many common techniques within the laboratory setting and is able to contribute their own observations and input to difficult projects. The scientist will execute 70% - 100% of their work at the bench level.
Roles and Responsibilities:
- Performs analysis of biopharmaceutical test samples using a variety of analytical methods such as HPLC, mass spectrometry (MS), capillary electrophoresis (CE), and gel electrophoresis;
- Develops and validates analytical methods used for the measurement of attributes of biologics, develops validation protocols and execute the validation plans;
- Performs peer-review of analytical data and reports;
- Prepares data for presentations and write final reports;
- Uses existing databases to document progress of projects. Track and report the status of assignments to management at the regular basis.
- Contributes to creating and distribution of detailed project status reports to all staff in department to facilitate decision making about new project assignments;
- Assists lab head in planning, implementing and evaluating laboratory procedures/systems;
- Works with other groups within the organization to solve both technical and process-related issues.
- Investigates, evaluates, and recommends the purchase of laboratory equipment;
- Demonstrates strong skill and expertise in specific laboratory methods;
- Troubleshoots instrumentation within area of expertise;
- Recommends improvements to methods and processes;
- Seeks out innovative ways to apply knowledge or skills to improve protocols and results;
- Actively engages overall project and ensures own work is aligned with overarching goals;
- Records experimental data, ensuring clear and accurate transcription of results and calculations;
- Shares technical expertise with other lab staff and serves as a mentor for them.
- Routinely applies personal experience, academic training, and technical insights to solve complex problems in the laboratory;
- Attends scientific seminars and conference;
- Recommends, and implements new approaches or processes to improve laboratory operations;
- Performs additional tasks as required for the position;
Scientist IV: Ph.D. in biochemistry or related field with five (5) years of relevant laboratory experience, or an MS in biochemistry or related field with seven (7) years of experience.
Scientist V: Ph.D. in biochemistry or related field with eight (8) years of relevant laboratory experience, or an MS in biochemistry or related field with ten (10) years of experience.
An equivalent combination of education and experience may be substituted. Laboratory experience must include chromatography, electrophoresis, and separation techniques in general. Candidate must be experienced in assay development and validation protocols and procedures following ICH, FDA, and USP.
- Background in spectroscopic methods or biological assays
- Individual must possess the ability to handle multiple priorities in fast-paced environment;
- Must possess excellent written and verbal communications skills;
- Results driven with demonstrated successful outcomes;
- Must possess excellent written and verbal communications skills;
- Strong background in protein chemistry, mass spectrometry and separation sciences;
- Experience in biotherapeutics characterization, intact protein analysis, peptide mapping, and post translational modification analyses. Desired expertise in HPLC, LC-MS( MALDI and Thermo Orbitrap), UV/Vis spectroscopy;
- Experience with SDS-PAGE, protein assays, Western Blot, Flow Cytometric assays;
- Experience working in the pharmaceutical and/or biotechnology industry strongly preferred;
- Working knowledge of common analytical methods and procedures, and expertise in calibrating and operating analytical instruments required;
- Good understanding of cell-based assays and enzymatic assays, as well as other general analytical chemistry and biological principles;
- Plans and conducts research projects independently and has the ability to build technical expertise in others by serving as a mentor.
- Ability to summarize and present data at department meetings
- Excellent communication as well as interpersonal skills required;
- Ability to work independently and as part of a team;
- Ability to learn new technologies and strong computer, scientific, and organizational skills.
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