Scientist III/IV, Biologics (1033-679)
This is a highly technical, hands-on, and non-supervisory position in USP’s Biologics & Biotechnology (B&B) Laboratory. In this role, the scientist is responsible for method and new technology development and evaluation, characterization of biologics, and collaborative testing of biologics reference standards in support of the function and activities at USP and Biologics Department. The scientist will work closely with Scientific Liaisons and Reference Standard Scientists in the compendial group. The scientist will have mastered common techniques within the laboratory setting and is able to contribute to provide input and solutions to the challenging 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 methods such as bioassay, potency tests, ligand binding assays, enzymatic assays, immunoassays, protein and DNA analysis
- Develops and validates methods for the measurement of attributes of biologics
- Generates final reports and prepares data for presentations
- Performs peer-review of data and reports
- Uses existing databases to document progress of projects. Track and report the status of assignments to management at the regular basis
- Works with cross-functional teams within the organization to solve both technical and process-related issues.
- Demonstrates strong technical skill and expertise in specific laboratory methods and troubleshoots instrumentation within area of expertise
- 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
- Shares technical expertise with other lab staff and serves as a mentor for them
- Recommends and implements new approaches or processes to improve laboratory operations
- Assists lab head in planning, implementing and evaluating laboratory procedures/systems
- Attends scientific seminars and conference
- Performs additional tasks as required for the position
Scientist III: Ph.D. in biochemistry or related field, or an MS in biochemistry or related field with five (5) years of experience.
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.
An equivalent combination of education and experience may be substituted. Laboratory experience must include bioassay, potency tests, enzymatic assays, immunoassays, protein and DNA analysis in general. Candidate must be experienced in assay development and validation protocols and procedures following ICH, FDA, and USP.
- Great understanding and experience in functional assays for biologics, such as ELISA, potency tests, enzyme based assays, ligand binding assays, microbial assay, PCR-based amplification, and protein analysis
- Experience in cell culture techniques and cell-based bioassay. Knowledge in cell immunofluorescence methods including fluorescent microscopic based method and flow-cytometric method is a plus
- Able to analyze and interpret data using appropriate statistical methods for relative potency determination, including but not limited to, PLA methods
- Good understanding and working knowledge of common analytical methods and procedures, HPLC, LC-MS, UV/Vis spectroscopy and CE helpful
- Experience in validation protocols and procedures following ICH and ISO guidelines
- Experience working in the pharmaceutical and/or biotechnology industry strongly preferred
- 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 various 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.
- Must possess excellent written and verbal communications skills;
- Results driven with demonstrated successful outcomes.
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