Description

Who is USP?

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities 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 1,300 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 Material Production position is a key management position responsible for operational aspects of Microbiology Reference Material (RM) production. The incumbent manages a production team, responsible for producing all USP Microbiology Reference Materials and provides strategic direction in the area of production planning, manufacturing, and fullfilment. This position is a critical component of USP’s core business and the incumbent is expected to provide leadership, achieve high quality standards, and maintain USP’s culture of safety.

How will YOU create impact here at USP?

In this role at USP, you contribute to USP's 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 Material Production has the following responsibilities:

• Responsible for the timely production of USP Microbiology Reference Materials and othermicrobiology laboratory products. This includes oversight of production planning and prioritization of tasks, projects, and activities completed by the RMP production teams. Critically evaluates throughout rates by monitoring production capacity to ensure timelines and market demand are met.

• Responsible for supply-chain management of input materials required for product manufacturing. Maintain relationships with critical suppliers and ensure integrity of seamlesssupply-chain. Oversee final product order fullfillment and product shipping activities.

• Oversee and maintain facility functionality to ensure efficient and timely production of qualitymicrobiology products. This includes proper qualification, calibration and maintenance ofequipment.

• Proactively involved in identifying solutions to critical technical problems related to RMproduction, including mechanical challenges, material issues, and process deviations.Collaborates with Quality Assurance and scientific staff to investigate critical product issues andestablish meaningful corrective actions. Provides guidance to staff on creation of deviation andinvestigation reports.

• Leads innovation and implementation of new processes and manufacturing capabilities thatallow for continuous improvement in the safe production of high-quality finished goods,including manufacturing scale-up activities. Serves in a cross-functional capacity with otherdepartments to develop and implement new processes. Reviews and approves change controls,calibrations/validations, and reports.

• Establishes training programs and develops individual and production team capability.Maintains and further develops technical expertise and provides training to staff in key aspects ofthe manufacturing process areas.

• Assists in the development and accomplishment of key departmental metrics. Ensures short/longterm goals are set and met within established timelines.

• Collaborate with scientific staff and subject matter experts on new product introductions andproduct development.

• Responsible for supervision of department production staff, providing leadership and mentoring for the safe, effective and efficient production of USP Microbiology Reference Materials. Develops and mentors staff not only in USP-related duties, but also in production expertise, communication skills, and workplace relationships.

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:

• Bachelor's degree in Microbiology, Chemistry, Engineering or a related scientific field and 5-7years of relevant experience.

• Minimum of one (1) yearof direct supervisory experience at the Manager level.

• Minimum of two (2) years of manufacturing experience.

• Proficiency in relevant computer applications (MS Word, Excel) and database experience.

• Strong communications skills, written and oral.

• Excellent critical thinking and problem solving skills.

• Ability to influence without direct authority.

• Excellent organizational skills and attention to detail.

Additional Desired Preferences

• Prior experience in a pharmaceutical manufacturing organization.

• Experience related to microbiology, molecular biology, or biochemistry.

• Understanding of ISO 9001, 17034 and 17025 guidelines, hazard communication and qualitysystems.

• Ability to manage multiple and complex projects while paying attention to detail, prioritizingassignments, and delegating tasks.

• Knowledge of DOT/IATA regulations.

• Demonstrated success as a strategic thinker, with the ability to make critical decisions using abroad, organization-wide perspective.

• Results driven with demonstrated successful outcomes.

• Demonstrated stakeholder collaboration experience, with the ability to quickly develop andmanage internal and external relationships and contacts.

• Successful experience training and mentoring staff in areas of technical expertise.

• Familiarity with the uses of Reference Standards, and with official compendia.

Supervisory Responsibilities

The incumbent will have management responsibilities for a team of 2 to 8 manufacturing staff.

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 $110,500.00 - $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