Manager, Reference Standards Evaluation (RSE)

Description

Who is USP?

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USPs fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare.

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 work—an environment where every employee feels fully empowered and valued irrespective of, but not limited to, 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.

Brief Job Overview

The Manager, Reference Standards Evaluation, is a supervisory position that will provide technical leadership as well as staff development and mentoring. Reference Standards Evaluation manager is responsible for the training, development, and management of scientists who primarily work on reference standards and related activities in support of reference standards procurement, qualification, authoring and/or reviewing protocols and reports. The position works in collaboration with documentary standards, reference standards lab, reference standards acquisition, technical operations, production etc. The incumbent will utilize their technical expertise and knowledge of the reference standard and materials development process and current regulatory guidelines, and strong organizational and communication skills to ensure development of high-quality reference standards and materials.

How will YOU create impact here at USP?

In this role at USP, you contribute to USPs public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.

The Manager, Reference Standards Evaluation, has the following responsibilities:

• Supervises a group of 3-5 BS to Ph.D. level scientists.

• Provides scientific and professional leadership to scientists working in the areas of reference standard evaluation, in accordance with established SOPs, business practices and procedures.

• Monitors and follows up as necessary the progress of collaborative studies and reference standards candidate evaluation packages (RSCEP) for reference materials.

• Manages and tracks group’s day-to-day activities, workload, deliverables and output; provides updates to the department head.

• Supports product investigations by reviewing the protocols, working in close collaboration with reference standard labs scientists and/or management.

• Authors, updates, reviews and / or approves SOPs, manuals.

• Initiates and /or reviews the deviations, determines the root cause and comes up with actions plans to minimize deviations.

• Reviews and /or approves early procedure evaluations prior / during the publication of monographs in the Pharmacopeial Forum, works in close collaboration with the New Use group to determine the new uses for the existing reference standards.

• Advises direct reports on corrective actions and path forward related to reference standards and materials development.

• Authors, reviews and/or approves reference standards test protocols, reference standards candidate evaluation packages (RSCEP), in compliance with USP policies, operational manuals, SOPs.

• Works with other groups/departments, as needed, to identify and resolve issues related to Reference Standards.

• Develops goals and related performance plans for direct reports.

• Prepares and conducts performance reviews for direct reports.

• Represents the Reference Standards Evaluation at Expert Committee, joint standards setting sub-committee meetings.

• Performs other duties as assigned.

Who is USP 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. in Chemistry or related field with at least 8 years of relevant experience or MS in Chemistry or related field with at least 10 years of relevant experience or BS in Chemistry or related field with at least 12 years of relevant experience.

• A minimum of 4 years of people management experience.

Additional Desired Preferences

• Ability to create good working, inclusive, safe and engaging environment.

• Thorough understanding of analytical technology such as NMR, qNMR, Mass Spec., IR, DVS, chromatographic techniques such as HPLC, GC, IC etc.

• Good understanding of the impact of reference standards in compliance setting.

• Familiarity with ISO standards and guides related to development of reference materials.

• Basic knowledge / familiarity with statistical analysis.

• Excellent written and verbal communications skills. Ability to communicate effectively and influence others.

• Ability to operate independently where appropriate yet understand when to escalate issues.

• Skills on establishing effective working relationships.

• Must have ability to prioritize and manage multiple, concurrent projects in a fast-paced and high-volume environment with changing deadlines and priorities.

• Able to work flexible hours when needed to meet the project timelines.

• Strong skills in troubleshooting and solving technical problems.

• Experience with, and knowledge of the USP-NF and use of reference standards.

Supervisory Responsibilities

Yes, 3-5 Scientists. Titles include Scientist, Sr Scientist, Principal Scientist.

Benefits

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

Compensation

Base Salary Range: USD $110,000.00 – $144,000.00 annually.

Target Annual Bonus: 13% Varies based on level of role

Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons.

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 contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Job Category Chemistry & Scientific Standards

Job Type Full-Time