(Senior) Principal Scientist, Microbiology

The U.S. Pharmacopeial Convention (USP)

Rockville, MD 20851

Posted 1 month ago

Job Description

**Description**


**Summary of the Position**


These positions are non-supervisory hands-on, highly technical roles that supports the standard-setting activities of the USP-NF. The incumbent is responsible for revising and developing new USP chapters associated with microbiology techniques working in close collaboration with USP’s Expert Committees.


**Roles and Responsibilities**


• Oversees and facilitates all aspects of the development of documentary Standards for the USP-NF. Evaluates and analyzes supporting data and converts into USP editorial style and format.


• Collaborates with Reference Standards Laboratories, Publications, Executive Secretariat, Compendial Affairs, and other departments on documentary standards -related issues


• Participates in the development and/or review of USP’s professional education course materials and may serve as an instructor


• Assists in the activities of the USP Expert Committees and Expert Panels, as needed.


• Provides general scientific related support to other scientific and managerial staff.


• Responds to inquiries pertaining to USP-NF monographs and General Chapters.


• Writes general and specific subject correspondence pertaining to USP standards


• Keeps abreast of current trends and developments in related scientific fields.


• Communicates with other USP departments regarding projects related to validation studies, method development, and reference standards.


• Serves as representative of USP at professional meetings (scientific meetings organized by USP and other organizations, meetings at other pharmacopeias or regulatory agencies etc.). Gives public presentations on USP matters (as assigned)


• Performs other related duties as required


**Basic Qualifications**


**Principal Scientist:**


• Ph.D. degree in Biology, or a related field, and five (5) yrs. of relevant experience, or


• M.S. degree in Biology, or a related field, and seven (7) yrs. of relevant experience, or


• Combination of relevant work experience and education may be substituted


• Knowledge of the pharmaceutical industry and the associated regulatory framework is essential.


• Direct, practical experience in the microbiology field in the pharmaceutical industry.


• In-depth knowledge of microbiological procedures for both sterile and non-sterile products.


**Senior Principal Scientist:**


• Ph.D. degree in Biology, or a related field, and eight (8) yrs. of relevant experience, or


• M.S. degree in Biology, or a related field, and ten (10) yrs. of relevant experience, or


• Combination of relevant work experience and education may be substituted


• Knowledge of the pharmaceutical industry and the associated regulatory framework is essential.


• Direct, practical experience in the microbiology field in the pharmaceutical industry.


• In-depth knowledge of microbiological procedures for both sterile and non-sterile products.


**Preferred Qualifications**


• Knowledge on alternate and rapid microbiological methods.


• Excellent written communication skills required with a focus on scientific writing for the pharmaceutical industry.


• Excellent verbal communications skills required including the ability to speak with authority and respect.


• Good interpersonal skills required including the ability to form strong relationships with team members and industry stakeholders.


**Supervisory Responsibilities**


None


**Benefits**


USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.


**About USP**


The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements 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.


The following COVID-19 provisions will apply to selected candidate(s) hired:


As a condition of employment with United States Pharmacopeial Convention’s (USP) duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after July 1st, 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.


Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities


The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)


**Job Category** Chemistry & Scientific Standards


**Job Type** Full-Time



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