(Senior) Manager, Reference Standards Laboratory (1030-679)
The (Senior) Manager, RSL position is a key supervisory position in the RSL Department, responsible for several aspects of reference standards and monograph evaluations and qualification operations. This includes project management, administrative supervision, technical leadership, and training and development of RSL employees. The incumbent in this role will utilize his or her technical expertise, knowledge of the pharmaceutical development process and current regulatory guidelines, and strong organizational and communication skills to ensure safe, high-quality, efficient and effective laboratory operations. The (Senior) Manager will be responsible for coordinating laboratory project prioritization for collaborative testing studies, Continued Suitability for Use, analytical procedure evaluation, new uses, and product investigations across RSL, working with other lab managers and monitoring and ensuring the prompt completion of critical projects in the lab as needed. This position is a critical component of USP’s core business that oversees the collaborative testing of USP’s reference materials, and the incumbent is expected to provide leadership and achieve high quality results.
Roles and Responsibilities:
- Prioritize and coordinate laboratory testing projects across the lab;
- Monitor and ensure effective completion of critical projects;
- Leads, manages, and directs laboratory team activities in the testing of reference materials (raw materials, APIs, drug products – small molecules, dietary supplements, and food ingredients);
- Manages laboratory resources with the philosophy of safety, quality, integrity, efficiency, and expense management;
- Sets daily priorities and holds employees accountable for results;
- Integrates internal and external best practices to facilitate the delivery of superior results;
- Leads the innovation and implementation of new processes and technologies that allow for continuous improvement;
- Proactively involved in identifying solutions to technical problems;
- Reviews and approves change controls, training documents, calibrations, SOPs, and reports;
- Ensures short/long term goals are set and met within timelines;
- Works with internal clients, manages projects appropriately, and ensures impeccable work-product delivery;
- Develops and mentors group staff;
- Assists in the accomplishment of key departmental metrics.
- Minimum of 2 years of direct supervisory experience.
- Working knowledge of common analytical methods and procedures (examples include: Infrared Spectroscopy (IR), Ultraviolet Spectroscopy (UV), Chromatography (TLC, HPLC, GC)), and expertise in calibrating and operating analytical instruments are required. Extensive understanding of chromatographic analyses, as well as other general analytical chemistry principles required. Proven track record of consistently delivering projects on time and with high quality. Ability to rapidly assemble the appropriate expertise to identify, define, and solve technical issues.
- Bachelor's degree in Chemistry, Pharmacy, or a related scientific field and 15 years of relevant laboratory experience or Master’s degree in Chemistry, Pharmacy, or a related scientific field and 12 years of relevant laboratory experience or D. in science and 10 years of relevant laboratory experience.
- Bachelor's degree in Chemistry, Pharmacy, or a related scientific field and 18 years of relevant laboratory experience or Master’s degree in Chemistry, Pharmacy, or a related scientific field and 15 years of relevant laboratory experience or D. in science and 12 years of relevant laboratory experience.
Skill to increase the knowledge, abilities, and contributions of staff. Proficient with testing involving compendial methods for reference materials (USP, BP, EP, etc.). Expert in HPLC and GC method development and troubleshooting, proficient in other related analytical instrumentation (ICP, AA, KF), hands-on knowledge of LC/MS or GC/MS preferred. Takes personal responsibility for delivery of projects to customers. Ability to embrace and lead change. Extremely adaptable. Excellent communication skills, both written and verbal. Strong presentation skills. Prior experience in a high volume pharmaceutical manufacturing QC laboratory or contract pharmaceutical analytical laboratory testing organization is a plus. Must be a U.S. Citizen or Lawful Permanent Resident.
Yes, this position has three direct reports (Team Leaders)
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