The U.S. Pharmacopeial Convention (USP) Director, Pharmaceutical Continuous Manufacturing Programs in Rockville, Maryland
Summary of the Position
The Pharmaceutical Continuous Manufacturing (PCM) Program Director is a key technical, leadership position within USP’s Global Health and Manufacturing Services (GHMS) Division focused on executing the USP’s PCM strategy. Within the next decade, USP will advance the supply of quality medicines by being a leading provider of services, standards, and solutions to industry and regulators seeking to use continuous manufacturing in their manufacturing and public policies. The PCM strategy accomplishes our mission objectives through three pillars – Science and Standards, Service Centers of Excellence (CoE), and Consulting. The PCM Director provides strategic leadership and influence across all three pillars as a member of the PCM Governance Committee and is specifically responsible for operational execution of the Service CoE pillar.
The Director will develop, gain support for, launch, and run programs focused on reducing barriers to adoption of PCM. This includes, but is not limited to, the USP CM Knowledge Center, USP CM analytical method development programs, and USP flow chemical process development programs. The Director will work with partners inside and outside of USP to seek government, donor, and/or commercial funding for PCM programs. Finally, the PCM Programs Director will advance USP’s thought leadership in CM by representing USP at various external stakeholder engagement events and fora, interactions online and in-person, and through trade press.
Roles and Responsibilities
• Leads a portfolio of programs focused on reducing barriers to adoption of CM within the pharmaceutical industry.
• Collaborates with the Compendial Science Group to execute standard setting program for PCM; in particular, work closely with the PCM science lead on translating learning from PCM programs into advances in science, standards, and best practice guidelines.
• Collaborates Pharmatech Associates – USP’s consulting subsidiary, on identifying, executing, and supporting consulting engagements with clients.
• As a member of the PCM Governance Committee, ensure that all three pillars of the PCM strategy are aligned, reinforced, accountable, and cohesively executed.
• Works closely with business development, government relations, and federal practice groups to identify and secure funding for PCM programs.
• Leverages knowledge and insights to continuously improve existing PCM programs, identify gaps, and develop plans to address those gaps.
• Create and manage external strategic stakeholder relationships relevant to key PCM developments and emerging strategic markets of interest for USP.
• Develop strong working relationships with internal and relevant external stakeholders at all organizational levels.
• Provides thought leadership internally and externally on new and emerging manufacturing technologies.
• Build and manage a small program team with expertise across manufacturing of active pharmaceutical ingredients, finished dosage forms, and biologics.
• Employ best practices in good people management, diversity, equity, inclusion, and belonging to build and/or support a high-performing team.
• Performs other duties as assigned.
• PhD in pharmaceutical science, chemistry, or chemical engineering or a related discipline required and eight (8) years’ experience in pharmaceutical sector, or relevant Master's degree with ten (10) years’ experience. Alternate combinations of experience and education may be considered.
• demonstrated understanding of the technical and economic decisions companies use when determining the viability of employing continuous manufacturing or other novel technologies.
• Experience leading multiple, complex, cross-functional projects.
• Experience working with external stakeholders is required.
• Experience in grant writing and securing funding of US government programs.
• Experience with continuous manufacturing technologies.
• Demonstrated thought leadership and technical expertise in advanced manufacturing technologies in the biopharmaceutical industry.
• Strong written and oral communication skills, inclding professional public speaking.
• Willingness to travel up to 20% of the time both domestically and internationally, adhering to COVID-19 protocols.
• Experience in at least one of the following areas: flow chemistry, control strategy development for pharmaceuticals using continuous manufacturing, or finished dosage form manufacturing using continuous manufacturing with preference for finished dosage form experience.
• MBA in addition to listed scientific degrees preferred.
• Understanding of global dynamics impacting the supply of quality-assured pharmaceuticals and medical products.
• Experience working in a matrixed environment, with a demonstrated ability to influence subject matter experts to successfully deliver projects.
Initially one (1) direct report – Senior PCM Manager. Additional direct reports may be added as programs develop. Indirect, supervisory responsibility over individuals involved in PCM programs, including internationally based programs.
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 Technical Programs
Job Type Full-Time