U.S. Pharmacopeial Convention Jobs

Job Information

The U.S. Pharmacopeial Convention (USP) Senior Director, Biologics Science & Standards in Rockville, Maryland

Description

This position is critical for the implementation of the USP biologics strategy, including the development and launch of a comprehensive pipeline of next generation of biological standards and solutions to cover the different therapeutic areas, enabling manufacturers to develop and release biological medicines.

The Senior Director, Science – Global Biologics, is a hands-on supervisory position responsible for executing and overseeing the organization’s scientific approaches for advancing public health through the development, update and implementation of documentary and reference standards. The candidate will maintain strong working relationships with key stakeholders in the biopharmaceutical industry as well as the US and international regulatory agencies, as well as global Pharmacopeial organizations.

The incumbent leads and develops his/her staff through mentoring and coaching to cultivate future science leaders. The individual will be part of the global biologics leadership team and will lead a global team of scientific staff that focuses on the development and the production of standards; he/she will collaborate with senior biologics staff, marketing, and strategic customer development teams to deliver the USP biologics industry solutions.

Roles and Responsibilities

  • Develops and executes the USP biologics strategy for documentary and reference standards development to support the USP-NF. Expands the scope of standards while aligning with the USP science quality framework

  • Implements processes for the new generation of biologics documentary standards, including novel approaches to stakeholders’ engagement and supports the evolving compendial approaches

  • Lead the development of physical standards including oversight on management of materials acquisition and scope of collaborative studies, as well as support to process improvement and modernization to support the new generation of biological reference standards

  • Drives resolution of technical and/or compendial issues related to documentary and reference standards in accordance with the Rules and Procedures of the Council of Experts, USP guidelines, standard operating procedures and other established USP practices.

  • Drives the achievement of USP’s ambition of continuously modernizing and strengthening USP-NF and eliminating the backlog of standards requiring modernization. Ensures that the team is aware of the strategy and ambition aligns goals and objectives accordingly.

  • Drives resolution of technical and/or compendial issues related to monographs and reference standards in accordance with the Rules and Procedures of the Council of Experts, USP guidelines, standard operating procedures and other established USP practices.

  • Supports the integration of global biologics activities including laboratory resources and support to education and training. Aligns on key strategies and resource prioritization, and compromises to find fair trade-offs between competing interests if necessary

  • Executes on USP’s ambition to becoming the definitive source of standards, strengthening USP-NF and eliminating the backlog of standards requiring modernization. Ensures that the teams are aware of the strategy and ambition; and aligns goals and objectives accordingly.

  • Establishes and maintains productive relations with the Council of Experts, Expert Committees, and Expert Panels to ensure the highest quality documentary and reference standards.

  • Collaborates closely with all USP staff /departments for establishing new processes and/or process improvement initiatives in areas of interest.

  • Supports the development of annual workplan and budget for revenue, expenses, and operating change targets for the focus areas, and ensures adherence to budget. Identifies solutions to budget constraints to ensure goals and objectives are not hindered.

  • Collaborates with the biologics industry solutions lead and the product development teams to grow USP’s biologics solutions offerings, supporting our customers in the life science and biopharma industries.

  • Develops and maintains relationships between USP, regulatory bodies, stakeholders, and other pharmacopeias.

  • Drives the effective achievement of the organization’s goals relating to productivity, quality, and efficiency. Tracks and reports frequently on the status of all department activities

  • Leads and develops staff within the department, encourages professional development by assisting in identifying opportunities for learning and professional growth.

Basic Qualifications

  • Bachelors degree or equivalent in a field of chemistry, biology, pharmaceutical science, or other relevant scientific field of study

  • Minimum of 12 years of industry experience including a minimum of 7 years of people management experience leading groups of senior scientific staff

Skills Sought

  • Track record and success as analytical scientist at a director level, including training and developing team members

Preferred Qualifications

  • Doctoral degree or equivalent in a field of chemistry, biology, pharmaceutical science, or other relevant scientific field of study

  • Demonstrated expertise in biopharmaceutical analysis including biological assays, separation science and other impurities-assessment techniques

  • Established knowledge of the biologics regulatory landscape and requirements

  • Understanding of USP standards-setting processes and compendial terminology

  • Knowledge of global biopharmaceutical industry and related trade associations

  • Demonstrated leadership and management capabilities

  • Ability to manage a global, diverse, and multi-faceted staff including, directors, scientists, and support staff

  • Ability to solve complex problems with keen instincts and organizational experience

  • Demonstrated ability to communicate complex ideas clearly and concisely

  • Demonstrated ability to collaborate and align across disciplines and departments

  • Excellent interpersonal skills, ability to develop important relationships with customers and key stakeholders, good conflict management skills

  • Demonstrated ability to translate strategy into action

  • Strong influence, negotiation, teamwork, and presentation skills

  • Global mindset and ability to travel, as needed

Supervisory Responsibilities

Team of directors and managers of laboratory and standard development teams

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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