Who is 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's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 hardworking professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Brief Job Overview
The Technical Director for Advanced Manufacturing Technologies (AMT) is a key scientific leadership position within USP's Global Health and Manufacturing Services (GHMS) Division passionate about executing the USP's AMT strategy. Within the next decade, USP will advance the supply of quality medicines manufactured using AMTs through groundbreaking research, commercial and government solutions, and standards.
The Technical Director for AMT leads USP's efforts to secure federal and private grant funding for research programs aimed at accelerating adoption of AMTs. To do so, the Technical Director will work with business development partners and science leaders inside and outside of USP to secure external funding. Finally, the Technical Director will act as either the principal investigator (PI) or program director for any donor funded programs in which they secured. This will be done in partnership with functional leaders across the organization in which the work is being done (e.g., USP Rockville laboratories, the USP Richmond AMT laboratory, USP India Flow Chemistry lab, etc.).
The current USP focus areas for AMT include pharmaceutical continuous manufacturing (PCM) (both drug product and drug substance), continuous bioprocessing and other biologics continuous manufacturing, additive manufacturing, and enabling advanced technologies such as process analytical technology (PAT) and digital modeling.
How will YOU build impact here at USP?
[40%] Securing donor funding
o Writes proposals for research grants, scientifically driven programs, and capability building initiatives focused in the AMT space. This includes state, federal, and international government opportunities and private donor funding
o Works closely with business development, government relations, and federal practice groups to identify and secure funding for AMT programs
o Works closely with the PCM science lead on targeting research grant programs to advance USP's long-term standard setting strategic plan
o Works closely with the PCM Programs Director on targeting grant programs to improve and support USP's solutions in the government and commercial sectors
[40%] Running donor-funded programs
o Leads the execution of grants won as either the identified Principal Investigator or as a technical program director when others in USP are the identified Principal Investigator
o Demonstrates results and impact of grant-funded programs for which the technical director is responsible and accountable
o Employ standard methodologies in good people management, program management, and diversity, equity, inclusion, and belonging (DEIB) to build and/or support hard-working teams in a matrixed management structure
[20%] Continuous program improvement
o Reports regularly to the PCM Governance Committee on grant and donor funding opportunities, operations, and opportunities for improvement
o Demonstrates knowledge and insights to continuously improve existing AMT programs, identify gaps, and work with program owners to address the gaps
o Develops strong working relationships USP's Digital and Innovation (D&I) division to support the transition of programs from D&I to grant-funded programming
Who USP is Looking For?
The successful candidate will demonstrate understanding of our mission, commitment to excellence through diverse and equitable behaviors and practices, ability to quickly build credibility with team members, along with the following competencies and experience:
- PhD in pharmaceutical science, chemistry, or chemical engineering or a related field required and 8- years' experience in pharmaceutical sector, or relevant master's degree with 12- years' experience. Alternate combinations of experience and education may be considered.
- Experience in grant writing and/or securing funding of US government programs.
- Experience in at least one of the identified AMT focus areas at a level to be a credible PI or program director (i.e., pharmaceutical continuous manufacturing (PCM) (both drug product and drug substance), continuous bioprocessing and other biologics continuous manufacturing, additive manufacturing, and enabling advanced technologies such as process analytical technology (PAT) and digital modeling).
- Experience leading multiple, complex, cross-functional projects; and doing so in a highly matrixed organization.
- Strong written and oral communication skills, including professional public speaking.
- Willingness to travel up to 20% of the time both domestically and internationally, adhering to COVID-19 protocols.
Additional Desired Preferences
In addition to the requirements above, the following are desired competencies and experience:
- Experience in 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
- Understanding of global dynamics impacting the supply of quality-assured pharmaceuticals and medical products)
- Strong understand of USP and the changing quality paradigms within the biopharmaceutical industry
- MBA in addition to listed scientific degrees
- No direct report employees currently
- Adding of director report employees may be needed as the AMT donor program develops
- Indirect or program management responsibilities are expected
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 is protected.
COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired:
As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work --from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
Note: 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 contractors legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Technical Programs
Job Type Full-Time