(Associate) Scientific Liaison, Compounding (968-679)

7 days left

Location
Rockville, Maryland, United States
Posted
Oct 12, 2017
Closes
Oct 31, 2017
Hours
Full Time

This is a non-supervisory position responsible for assisting in the coordination and execution of the Compounding Expert Committee’s (CMP EC) work plan, focusing on the standards development related to sterile and nonsterile compounding, compounding for investigational studies, and handling of hazardous drugs. In addition, this position facilitates healthcare practitioner input into all USP’s Expert Committees standards-setting activities. The incumbent in this role will be responsible for assisting in compounding related activities including preparing for Compounding Expert Committee meetings, coordinating critical evaluation of relevant literature, reviewing analytical method development, validation and stability studies to support compounded preparation monograph development, and supporting education and outreach of compounding standards. This individual will support development and revision of USP compounding standards, engage in outreach and promote adoption of these standards, and support additions to the USP Compounding Compendium. This position will also work closely with the Science Program Manager and support the development of new compounded preparation monographs through the Compounded Preparation Monograph Donation Program (CPM Donation Program).

Roles and Responsibilities:

  • Provide assistance and advice on issues related to compounding and USP standards. Keep abreast of current trends and developments in compounding, investigational studies, and handling of hazardous drugs.
  • Provide support to Science Marketing Program Operations to develop implementation tools for USP compounding standards including course development and Mobile App support.
  • Engage with stakeholder organizations to promote USP compounding standards which includes presenting at national meetings and participating in relevant discussions.
  • Support the Science Program Manager in seeking donations and forming relationships with potential donors to support development of compounded preparation monographs.
  • Work with the Program Manager on contract laboratory studies for the development of compounded preparation monographs. Evaluate and analyze method validation and stability reports for suitability; summarize data and coordinate Expert Committee review; translate specifications into USP editorial style and format; and assist in moving proposed monographs for approval through USP process for publication.
  • Provide needed guidance on general and specific subject correspondence pertaining to compounding monographs, general chapters and various USP policy issues both internally and externally. Provide responses to inquires related to USP compounding standards.
  • Assist in development and revision of USP compounding general chapters based on Expert Committee recommendations, stakeholder input, and scientific evidence.
  • Assist in planning and organizing activities of subcommittees and form Expert Panels as needed to guide the development and revision of compounding standards.
  • Provide guidance, support, and resources to the subcommittees and Expert Panels on special compounding topics
  • Act as USP liaison for governmental inter-agency activities.
  • Perform other related duties as assigned.

Basic Qualifications: 

Associate Scientific Liaison level:

  • Pharmacist with a doctoral degree in pharmacy, chemistry or pharmaceutics and 5 years or MS and 7 years, respectively, of relevant experience preferably in compounding; alternatively pharmaceutical, biotechnology or life science industry experience may be applicable.
  • An equivalent combination of experience and education may be substituted (eg., RPh, MPH, MS in Nursing, Pharmacy or Healthcare related field).

Scientific Liaison level:

  • Pharmacist with a doctoral degree in pharmacy, chemistry or pharmaceutics and 8 years or MS and 10 years, respectively, of relevant experience preferably in compounding; alternatively pharmaceutical, biotechnology or life science industry experience may be applicable.
  • An equivalent combination of experience and education may be substituted (eg., RPh, MPH, MS in Nursing, Pharmacy or Healthcare related field).

 

Preferred Qualifications: 

  • Experience in analytical chemistry and compounding is a plus.
  • Understanding and knowledge of organizational development within the context of non-profits.
  • Operates collaboratively at all levels of the organization in a highly technical environment.
  • Possesses knowledge of applicable Federal Food, Drug and Cosmetic laws, regulations, and/or codes as they relate to compounding. Possesses knowledge of the FDA’s Drug Quality and Security Act of 2013, Compliance Policy Guide (CPG) for both human and animal drug use, OSHA regulations on hazardous drugs, and NIOSH Alerts on exposure to antineoplastic drugs.
  • Understanding of USP standards-setting processes and compendial terminology. Expertise in contemporary compounding practices and associated professional activities. Knowledge of global pharmaceutical and healthcare industries and related trade associations.
  • Well-developed organizational, interpersonal communications, negotiation, writing, attention to detail, and strong listening skills.
  • Strong analytical skills and ability to work on basic processes as well as strategic initiatives required. Expertise in evaluating research of evidence-based information. Demonstrates creativity, flexibility, and the ability to develop and review effective Expert Committee and Expert Panel work plans consistent with organizational mission and objectives. 
  • Strong presentation and overall communication skills, both written and oral.
  • Able to effectively prioritize and efficiently manage multiple programs.
  • Able to operate independently where appropriate, yet understand when to escalate issues and how to establish effective working relationships in a team setting.
  • Must be proficient in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet).

Supervisory Responsibilities:

No supervisory responsibilities

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