(Associate) Reference Standards Manager - Biologics

U.S. Pharmacopeia

Location: Rockville, Maryland-Montgomery County 20852
Posted on: 10/30/2009 6:25:06 AM
Postion type: Full time
Job Code: BW10516
Required Education: Master's Degree
Salary:

DESCRIPTION
Calling all biologics and biotechnology leaders! USP wants YOU! If you are seeking an opportunity to leverage your considerable technical skills AND your outstanding leadership capabilities, we encourage you to read on.

The United States Pharmacopeia (USP) is an official public standards–setting authority for all prescription and over–the–counter medicines and other health care products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years.

The Reference Standards Manager is a key supervisory position providing project management and technical leadership as well as staff development and mentoring. Reference Standards Managers are responsible for the training, development, and management of Reference Standards Evaluation (RSE) employees. The incumbent will utilize his or her technical expertise, knowledge of the pharmaceutical reference standard development process and current regulatory guidelines, and strong organizational and communication skills to ensure development of high quality reference standard materials. This is a critical role within the organization that oversees the operations of USP’s reference materials evaluation team.

Roles and responsibilities:
•Proactively involved in identifying solutions to the most critical technical problems related to the development of testing protocols and the analysis of data;
•Develops and mentors staff not only in USP-related duties but also in scientific expertise, communication, and workplace relationships;
•Ensures consistency, timeliness, and the highest quality in all group outputs;
•Develops and integrates internal and external best practices to facilitate the delivery of superior results;
•Reviews and approves training documents, SOPs, and internal/external reports and communications;
•Sets group priorities and holds employees accountable for results;
•Leads, manages, and directs group activities (literature review, collaborative testing protocol development, troubleshooting of analysis methods, communication with internal and external customers);
•Leads the innovation and implementation of new processes that allow for continuous improvement;
•Ensures short/long term goals are set and met within timelines;
•Works with internal clients, manages projects appropriately, and ensures impeccable work-product delivery;
•Assists in the accomplishment of key departmental metrics; and
•Represents RSE products and scientific expertise at internal and external meetings, scientific symposia, industry forums, and Expert Committee meetings.

REQUIREMENTS:
Ph.D. in Biology, Biochemistry, Microbiology, Chemistry or related field and 8 years or MS and 10 years of relevant experience. Minimum of 5 years project lead and/or scientific reviewer experience required. Previous supervisory/mentoring experience with the ability to demonstrate superior leadership through interaction and communication, urgency, planning, and technical ability. Proven track record of consistently delivering projects on time and with high quality. Ability to rapidly assess technical complications to identify, define, and solve technical issues. Skill to increase the knowledge, abilities, and contributions of staff and promote staff development. Broad knowledge of projects, internal experts, and technologies within and outside the laboratory. Proficient with testing involving analytical methods for raw materials. Proficient in related analytical analysis and instrumentation (HPLC, CE, NMR, ICP, AA, KF, UV, LC/MS, GC/MS). Ability to review, analyze, interpret and report on data from various analytical tests. Ability to embrace and lead change. Extremely adaptable. Excellent communication skills, both written and verbal. Strong presentation skills. Prior experience in biological reference standard development, testing, or production is a plus. Experience with the development of biological pharmaceuticals and refining specifications during the development cycle. Knowledge of and experience with stability programs.

To learn more about this opportunity, please visit www.usp.jobs and apply online today!

We are proud to be an AA/EEO employer M/F/D/V. Women, minorities, veterans, and disabled persons are encouraged to apply. If you are interested in applying for employment with the United States Pharmacopeia and need special assistance or an accommodation to apply for a posted position, please contact our Human Resources department at 301-816-8242 or humanresources@usp.org.

Local candidates preferred. Relocation assistance provided.

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