Director, Reference Standards Laboratory

United States Pharmacopeia
North Bethesda, MD
Closing date
Oct 4, 2023

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Pharmaceutical, Laboratory
Organization Type

Who is 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's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

Brief Job Overview

The Director, Reference Standards Laboratory (RSL), is a hands-on supervisory position responsible for overseeing a large team of scientific professionals performing chemical and physical testing of new candidate reference materials issued by the United States Pharmacopeia (USP). The incumbent assists in fostering an innovative, productive and achievement-based culture in the laboratory. The director will lead, motivate, and mentor their laboratory team members to achieve their maximum potential while meeting production goals. They ensure laboratory scientific policies and practices are followed and all work is performed with the highest possible quality. At the same time, the incumbent will look for continuous improvement opportunities to increase productivity, quality, and efficiency. They will also work closely with both internal and external USP stakeholders to exchange information, obtain resources, solicit input, and advance the work. The incumbent is also responsible for the maintenance and improvement of the lab management system.

How will YOU create impact here at USP?

[40 %] Laboratory Operations and Program Delivery

Provides leadership and management of the Reference Standards Laboratory at USP.

Provides leadership to scientists working in the area of collaborative testing of Reference Standard (RS) candidates, product investigations, and Continued Suitability of Use (CSU) and New Use (NU) studies in accordance with established SOPs, guidance documents, and business practices and procedures.

Establishes goals and metrics for the team, ensuring alignment with the laboratory and organizational goals, and evaluates performance against established goals.

Manages and plans projects, personnel, and schedules to perform specific projects according to deliverables and overall business priorities; provides updates to department head.

Takes the lead in working with other departments within the organization to solve both technical and process-related issues.

Develops and implements laboratory budget, including expenses for personnel, travel, supplies, and capital expenditures.

[30 %] Staff Development and Diversity, Equity, Inclusion, and Belonging (DEIB)

Recruits, develops, and mentors laboratory personnel to ensure full staffing and performance while cultivating a collaborative team culture, creative problem solving and result-driven operation.

Promotes the fundamental management philosophies of Safety, Quality, Efficiency, and Expense Management.

Understands and executes on individual professional development plans for each scientist by assuming an appropriate mix of training, mentoring, and stretch project activities.

Engages in activities consistent with USPs DEIB goals and objectives to make working for USP a place every staff member feels belonging and can bring their best, authentic professional self to work each day.

Develops staff and succession plans to meet the business needs of the organization.

[20 %] Quality Systems

Supports implementation, maintenance, and improvement of the USP Lab Management System.

Ensures the quality, safety, and operational procedures are created, updated, and followed to ensure effective running of the laboratory.

Maintain and improvement of Quality Management Systems.

[10%] New Initiatives

Leads the innovation and implementation of new processes and technologies that allow for continuous improvement.

Represents the laboratory at various scientific meetings, working groups, cross functional teams and new mission priorities.

Demonstrates a strong desire to continue learning and grow personal capability.

Participates on committees and task forces for strategic planning of the organization.

Who USP is Looking For?

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

Ph.D. or equivalent professional degree in chemistry with at least ten (10) years of broad analytical laboratory experience, or a M.S. in chemistry or equivalent professional degree with at least twelve (12) years of relevant experience. In addition, at least five (5) years of management and leadership experience is required. Direct supervisory experience in a laboratory setting, including effectively integrate mentorships, development programs, and DEIB initiatives. Demonstrated vast experience in analytical chemistry including method development, validation and & material characterization.

Additional Desired Preferences

Outstanding oral and written communication skills.

Works and communicates well with internal and external stakeholders to complete tasks.

Good understanding of chromatographic and spectroscopic analyses, as well as other general analytical chemistry principles.

Working knowledge of regulatory and quality guidelines applicable to pharmaceuticals and analytical testing, specifically ISO 9001/17025 and ICH.

Takes personal responsibility to ensure work is delivered on time and is of the highest possible quality.

Influential leader with the ability to drive problem resolution, transformation, and organizational change.

Demonstrated research, technical, and analytical skills, as well as the ability to take highly technical scientific information and make strategic recommendations quickly.

Experience working in a pharmaceutical and/or biotechnology laboratory strongly preferred.

Should have some familiarity with an industrial house standards program. Working knowledge of cGMP/cGLP, and other roles characterizing active pharmaceutical ingredients or excipients is preferred.

Proven leader in creating high-performance work teams; a strong team builder with the ability to delegate effectively and a track record of training and developing scientific staff.

A strong focus on quality improvement; excellent interpersonal skills and the ability to deal with multiple constituents, including senior scientists, government agency leaders, highly technical professional staff, and international colleagues and partners. Ability to handle national and international presentations to large groups.

Excellent listening skills. Superior interpersonal skills and ability to function in a team-oriented, highly collaborative environment are essential.

Supervisory Responsibilities
3-5 direct reports including Managers/Senor Managers and Senior Scientists.

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 is protected.

COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired):

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

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our workfrom the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

Note: 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.

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 contractors legal duty to furnish information. 41 CFR 60-1.35(c)

Job Category Laboratory/Production

Job Type Full-Time

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