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The U.S. Pharmacopeial Convention (USP) Senior Manager, Incubation - Product Quality & Analytical Method in Rockville, Maryland

Description

Summary of the Position

The Product Quality and Analytical Methods (PQQM) Department has an immediate opening for a Senior Incubation Manager. This position will be a core member of PQAM and as such, They/Them will play a leading role in the identification, evaluation, prioritization and management of incubation projects and initiatives. As such, this position requires a high level of scientific skill and expertise, insight, and creativity as we work toward identifying emerging and evolving technologies and applications for the medium to long term opportunities for USP’s role in the future. As a core member of the team, together, we will explore the leading edge of tomorrow as we progress toward the continual growth and expansion of USP and its core mission of Public Health and Quality of Medicines for all. This position will focus on providing scientific expertise, leadership, and guidance for incubation projects as well as with other departments within D&I and USP. In addition, this position will also provide for the exploration of independent research interests including opportunities for laboratory activities as appropriate. This is a hybrid position and will follow USP’s policy for hybrid positions.

The Product Quality and Analytical Methods Department (PQAM) within the Digital and Innovation (D&I) Division, supports USP’s Mission by identifying and promoting emerging opportunities, initiating, and conducting early research and incubation of projects (laboratory and non-laboratory) and initiatives focused on exploring emerging technologies and trends that may impact USP or its industry stakeholders. These are accomplished through close collaborations with the Early Research Pipeline and Informatics Incubation departments as well as other departments within D&I and throughout USP. The research incubation projects are typically led by PhD level Scientists with various levels of experience requiring they/them to provide scientific leadership but also guidance in navigating them through the requirements and processes of USP. Examples of incubation projects include expanding the use and applications of qNMR using benchtop NMR instruments, evaluating small vessel capabilities for dissolution testing, DNA analysis for Botanical Identification, evaluating polymer material characterization technologies and spectroscopic data comparability approaches using handheld Raman instruments. In addition, PQAM will also continue to expand the Microgrant program that aims at promoting and provide seed funds for innovation projects throughout USP. In collaboration with the Director, PQAM, and appropriate staff, this will involve the reviewing/approving projects submitted by USP staff, working the recipients on progress of the projects, and developing mechanisms to publicize their results and to further promote the Microgrant program. PQAM’s approach, in collaboration with appropriate D&I and USP departments, follow a typical product development funnel starting at ideation, proof of concept (PoC), and project incubation. PQAM collaborates with both internal and external partners to ensure the successful graduation of new concepts. Our areas of interest range from advanced therapies, new analytical technologies, to informatics and digital innovation applications as well as emerging technologies and applications for manufacturing, production, and distribution.

This position has three primary areas of responsibilities:

  • Management of Scientific Fellows . They/them will be responsible for management of PhD level Scientific Fellows. This includes the design, development, initiation, and execution of accepted projects. They/Them will manage the coordination of the project(s) with appropriate departments and divisions and to communicate status and updates as requested by Director PQAM and other Senior Leaders. These projects may be primarily laboratory based in nature but is not limited to only laboratory based projects.

  • Identification, evaluation, and prioritization of future opportunities . They/Them will be expected to provide their scientific and experiential knowledge and expertise through active participation within D&I such as the Early Research Pipeline and Informatics Incubation departments as well as other appropriate divisions / departments and Program Unit Teams (PUT) for the identification and prioritization of future opportunities and to work to initiate projects as appropriate.

  • Establishing area of research interests . They/Them will have opportunities to identifying and spearhead independent research areas of interest, furthering their scientific and innovation ideas and goals as they pertain to the overall goals and strategy of USP. This provides an excellent opportunity for those looking to expand on their interest and to work with various groups and leadership teams throughout USP to bring ideas and opportunities forward for potential development. This person will take the lead, building internal and external support and network to explore and expand the interest throughout USP as appropriate. This may, as appropriate, also include hands-on laboratory activities as well.

The strategic plan for PQAM, includes identifying advanced analytical technologies and trends, assessment/prioritization for concept development and project initiation and graduation. They/them will have the scientific and technical skills to understand issues and challenges as well as creativity in overcoming challenges. They/them, in concert with the Director, will provide the scientific and leadership skills for the assessment of future technologies as well as its integration into USP.

The position is based in USP's corporate headquarters in Rockville, MD.

Roles and Responsibilities:

PQAM Innovation Strategy and Execution:

  • In collaboration with Director

  • Identify operational/strategic needs and opportunities for growth/expansion of PQAM activities

  • Creation, communication, execution, and adaption of PQAM strategy

  • Collaboration with the Early Research Pipeline, Informatics Incubation Departments and other USP divisions/departments to provide technical assessments, evaluations and input on emerging technologies and trends and their potential impact to USP

  • Identify and evaluate technologies with respect to timing and potential impact on the industries USP works in, how USP develops standards, and the way those standards may be used

  • Prioritize identified technologies and prepare proposals for submission as potential incubated projects.

Scientific Leadership

  • Collaboration with appropriate USP laboratory and non-laboratory staff with respect to initiation and on-going activities of incubation projects and initiatives as appropriate.

  • In collaboration with Director, PQAM, Facilities and other appropriate staff, identify, internal and/or external, laboratory capacity for projects.

  • Ability, if appropriate, to perform laboratory experiments using analytical technologies and methodologies.

Project Oversight

  • Direct supervision and guidance of Scientific Fellows for both laboratory and non-laboratory -based projects, developing projects plans, identification of needs and constraints, ensuring execution and successful completion of projects.

  • Understand internal and external requirements and constraints with respect to USP processes and policies for projects and initiatives.

  • Initiate, develop, and track work plans, including dashboards, timeframes, milestones, key research activities and employ appropriate communications for presenting and disseminating progress.

  • Communicate, both written and oral, with respect to project updates and progress, technology evaluation, requirements, applications, and potential impact to a wide range of audiences including technical and non-technical backgrounds and expertise as well as various levels of management.

USP Integration

  • Initiate, and establish avenues of communications with appropriate Divisions and Departments with respect to incubation project status, progress updates and risks.

  • Identify impacted groups and develop working relationships and lines of communication

  • Work with appropriate departments and divisions, science, and non-science, to promote, initiate and develop integration plans for graduation of incubated projects

  • Establish and promote relationship and communications with departments and divisions to ensure projects meets the needs for future integration and graduation

  • Other duties as assigned.

Basic Qualifications:

Education and Experience:

PhD with 3 years or Master with 5 years of experience within an appropriate field of science such as Chemistry or Biology. Experience in technology assessment and evaluating organizational impact. Experience in working in a diverse groups and environments that include scientific and non-scientific participants. Experience in working within a matrixed management and with direct reports focusing on driving projects to completion.

Preferred Qualifications

The ideal candidate will also have exhibited the following soft skills:

  • High degree of emotional intelligence, enthusiasm, and curiosity.

  • Good at working with multiple stakeholders and skill levels.

  • Excellent verbal, written and presentation skills.

  • Leadership skills; demonstrated negotiation, planning, and project management skills.

  • Initiative-taker and curious with the desire for continual learning

The ideal candidate will have knowledge and demonstrated success in:

  • Laboratory experience in performing experiments, critical analysis of acquired data and laboratory operations.

  • Communicating technical information to a broad-based audience.

  • Ability to quickly learn innovative technologies in sufficient detail to provide insight and guidance to subject matter experts conducting research, and other concept development activities.

  • Assessing potential impact(s) of technologies with respect to USP

  • Determining impacted groups and developing working relationships with those groups to ensure smooth transitions

  • Management of Direct Reports

  • Ability to manage multiple research projects in parallel

Other Qualifications include

  • Managing and executing projects

  • The ability to influence others without direct authority

  • Results driven with demonstrated successful outcomes

  • Ability and desire to collaborate well with diverse employees and customers in a cooperative and friendly manner

  • Ability to manage multiple priorities in a fast-paced environment

  • Excellent written and verbal communications skills.

Supervisory responsibilities

None

COVID Provisions

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

Benefits

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 are protected.

About 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 brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements 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.

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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