Manager, Analytical Laboratory Services (882-679)
This is a supervisory position with the primary responsibility of working with a team of analytical chemists directly supporting quality control (QC) testing of medicines and providing technical training to field laboratory staff in support of laboratory ISO 17025 accreditation and/or WHO prequalification. The incumbent supervises the testing of finished pharmaceutical products using various analytical techniques including HPLC, dissolution, TLC, and other spectroscopic and chromatographic techniques; and also lead independent research or collaborative research activities with external stakeholders. The position supports the USAID funded Promoting the Quality of Medicines (PQM) program implemented by the United States Pharmacopeia, under the Global Public Health department.
Roles and Responsibilities:
- Manages all PQM laboratory activities and interacts with clients as necessary
- Supervises and conducts testing of medicine samples using compendia test methods and utilizes his/her technical skills to ensure safe, efficient, and effective laboratory operations
- Takes the lead in working with other departments within the organization to solve both technical and process-related issues
- Provides leadership, guidance, training, and mentorship for scientists in the laboratory regarding technical knowledge, work ethic, and attitude
- Performs review of all PQM laboratory project reports and has responsibility for the scientific integrity of data generated by the PQM analytical services group
- Investigates new analytical techniques for analysis of medicine products
- Represents PQM at meetings involving the dissemination of laboratory results to stakeholders
- Reviews, interprets and evaluates scientific data; and presents laboratory results to a scientific audience
- Develops plans for success to help support project deadlines
- Organizes, implements, and evaluates collaborative studies in the laboratory
- Assists PQM Deputy Director in planning and implementing major PQM laboratory projects/programs
- Leads original research activities, including method development and validation
- Manages PQM programmatic work at country level such as training and providing technical training towards international quality standards accreditation
- Provides training in analytical techniques and in drug quality testing and GLP to laboratory staff at the country level
- Supports GMP inspection of pharmaceutical manufacturing QC labs
- Coordinates activities related to acquisition and development of USP monographs of interest to PQM, with the relevant USP departments and PQM program managers
- Develops a thorough knowledge of USP’s personnel policies and procedures an in-depth understanding of the USP and its revision process, and of the reference standard evaluation and development process
- Performs other duties as assigned
- Minimum of eight (8) years for Ph.D. (or 10 years for Master’s degree, or 15 years for a Bachelor's degree) of relevant quality assurance/quality control experience, preferably in a pharmaceutical or other related industry. Minimum of 3 years’ experience in direct supervision of a team of professional staff
- Degree in a physical science or health related field required; ideally in chemistry, chemical or biological engineering, pharmaceutical sciences, pharmacy, pharmacology, public health, medical science, or biology
- Demonstrated experience in project management. Previous experiences managing multiple projects simultaneously, working in multisector environment, and coordination of concurrent priority activities essential.
- Detailed understanding of GLPs, general understanding of current Good Manufacturing Practices (cGMPs)
- Demonstrated experience with testing using compendia methods (USP, BP, Pharm. Int., etc.)
- Understanding of ISO 17025, 9001, and WHO Prequalification; and general understanding of current Good Manufacturing Practices (cGMPs).
- Knowledge of analytical chemistry and quality assurance/quality control of medicines in the pharmaceutical industry required
- International health or development experience desirable (WHO, USAID programs); experience in working with international development organizations in lower and middle income countries desired.
- Excellent written and verbal communication skills.
- Excellent computer skills in Microsoft Office, particularly Power point and Excel. Competence in use of MS Office Suite.
- Demonstrated experience in supervision, and excellent interpersonal and organizational skills
- Demonstrated ability to multitask and manage competing priorities with minimal supervision.
- Detail oriented and demonstrated ability for high performance
- Knowledge of public health and pharmaceutical quality issues in developing countries a plus.
- Knowledge of principles of controlling diseases of priority public health importance is a plus.
- Language skills a plus (English, Spanish, or French)
- Ability to travel at least 30% of the time to international locations.
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