U.S. Pharmacopeial Convention Jobs

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The U.S. Pharmacopeial Convention (USP) Principal Scientist in Rockville, Maryland

Description

Summary of the Position

A comprehensive pipeline of next generation biological standards to cover the different therapeutic areas is critical for the implementation of the biologics strategy. The Principal/Senior Scientist in Biologics Pipeline Development is a hands-on non-supervisory role that will be responsible for identifying and evaluating opportunities for new biological standards. The role includes collaborating with key stakeholders and thought leaders in the industry, to identify and prioritize opportunities, design feasibility and proof of concept studies, and liaise with both internal and external partners throughout development.

Roles and Responsibilities

  • Identifies opportunities for new standards and solutions to address analytical challenges associated with the next generation of biological medicines. Plans and executes industry and regulatory roundtables aimed to gather input from stakeholders. Works with technical writers and marketing teams on delivery and posting of summaries and white papers as applicable.

  • Participates in the development of strategies and processes for the elaboration of a steady pipeline of standards.

  • Develops relationships with key stakeholders from academia and industry to engage in collaborations in early pipeline development projects. Initiates, defines, and leads collaborative projects.

  • Plans and oversees necessary laboratory work for feasibility and proof of concept studies. Evaluates and analyzes scientific reports and identifies next steps and key challenges. Engages and builds relationships with internal and external laboratories to participate in round robin studies in support of feasibility and proof of concept studies.

  • Partners with the standards production team for eventual handoff leading to planning and initiation of standards development projects. Collaborates with the biologics program unit team, specifically the strategic marketing and business development teams, to gather insights based on internal and external data to inform on opportunities for further exploration. Communicates and maintains working relationships with other USP departments, as applicable

  • Supports USP to build its external presence through presentations at conferences and publications

  • Keeps abreast of current trends and developments in related scientific fields, particularly in the area of cell and gene therapy.

Basic Qualifications:

Principal Scientist

  • Ph.D. degree in Biochemistry, Biology, Pharmacy, or a related field and ten (10) years, or M.S. degree and twelve (12) years of relevant experience in analytical development for biotherapeutics.

  • Experience in process development, analytical characterization, and chemistry and manufacturing control (CMC) for cell and/or gene therapies

Senior Scientist II

  • Ph.D. degree in Biochemistry, Biology, Pharmacy, or a related field and eight (8) years, or M.S. degree and ten (10) years of relevant experience in analytical development for biotherapeutics.

  • Experience in process development, analytical characterization, and chemistry and manufacturing control (CMC) for cell and/or gene therapies

Preferred Qualifications

  • Strong scientific, technical, and regulatory understanding of Cell and/or Gene Therapy development

  • Knowledge of reference standards related to biopharmaceutical products/industry.

  • Experience in method development and characterization of biological products, impurities, and raw materials using a variety of physicochemical techniques and biological assays

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

  • Knowledge of the global regulatory requirements and their applicability to advanced therapies

  • Strong writing skills and experience drafting technical reports related to material characterization, method development and reference standard evaluation.

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

  • Ability to establish and nurture relationships with individuals of varying backgrounds and learning styles.

  • Excellent presentation and communication skills (written and oral).

  • Ability to communicate technical information with non-technical or non-scientific staff, and to interact effectively with representatives from pharmaceutical companies, government, and academic institutions. Ability to persuade corporations to collaborate with USP on various projects.

  • Effective at operating independently where appropriate yet understands when to escalate issues and how to establish effective working relationships.

  • Able to perform in a fast-paced environment with changing deadlines and priorities. Ability to manage and prioritize multiple, concurrent projects

  • Experience with reference materials development is a plus.USP offers an impressive benefits package, including:

  • Generous paid time off – 15 paid holidays, 10 sick days and 15 vacation days per year to start

  • An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately

  • Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles.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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