The U.S. Pharmacopeial Convention (USP) Director, Biologics Pipeline Development in Rockville, Maryland
Summary of the Position
A comprehensive pipeline of next-generation of biological standards to cover the different therapeutic areas is critical for the implementation of the biologics strategy. The Director, Biologics Pipeline Development, is a hands-on supervisory position responsible for the development and delivery of a suite of portfolio and pipeline reports to inform and support decision-making on standards setting priorities. The incumbent will lead a team of scientific staff that focuses on identifying opportunities for standard development and designing and conducting studies to assess feasibility and proof of concept for standards development initiatives in biologics.
Roles and Responsibilities
• Develops and leads strategies and processes for the elaboration of a steady pipeline for standards to support the analytical evaluation of different classes of biotherapeutics.
• Collaborates with the biologics team and other USP departments, to gather insights based on internal and external data and perform analyses to inform on opportunities for further exploration.
• Contributes to the program unit annual strategic planning for portfolio and pipeline commitment goals. identifies and prioritizes the use of internal and external resources for the execution of the development work.
• Provides guidance and mentorship to the team of scientists responsible of pipeline development and coaches them on approaches to engagement of internal and external stakeholders.
• Supports the planning and execution of 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.
• 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 leads for eventual handoff leading to planning and initiation of standards development projects.
• Develops partnerships with key stakeholders from academia and industry to engage in collaborations in early pipeline development projects.
• Leads efforts to identify partners and contract research laboratories, decides on the collaborative framework and works closely with legal team to implement the appropriate agreements and contracts.
• Oversees preparation of documentation and discussions to support decision making and effective prioritization of projects. Designs and tracks metrics related to deliverables of scientific programs.
• Supports USP to build its external presence through presentations at conferences and publications
• Ph.D. or M.S. degree in Biochemistry, Biology, Pharmacy, or a related field and ten (10) years of relevant experience in analytical development for biotherapeutics. An equivalent combination of experience and education may be substituted.
• Minimum of 5 years of experience supervising, leading teams, training, or mentoring of other staff members, including scientific staff.
• Strong experience in the areas of characterization and analysis of biopharmaceuticals.
• Knowledge of compendial standards related to biopharmaceutical products/industry.
• Strong understanding of the regulatory guidelines applicable to biopharmaceuticals, specifically the chemistry and manufacturing control (CMC) requirements
• Demonstrated success in a people leadership role. Strong business acumen combined with both management and leadership ability.
• Effective coach and mentor to staff. Ability to identify and develop talent.
• Demonstrated stakeholder collaboration experience, with the ability to quickly develop and manage internal and external relationships and contacts.
• Excellent written and verbal communication skills, including ability to develop and deliver presentations to Senior Management and the entire organization.
• Demonstrated research, technical, and analytical skills, as well as the ability to take highly technical scientific information and make quick strategic recommendations.
• Ability to lead in a fast paced environment with changing deadlines and priorities
Senior scientific staff (4-6)
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.
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.
The following COVID-19 provisions will apply to selected candidate(s) hired:
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.
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