This is a non-supervisory scientific leadership position in the Small Molecules department within the Global Science and Standards Division. The incumbent is responsible for developing and advancing USP’s impurities strategy to support documentary standards development. The incumbent will lead cross-function teams to address existing and novel challenges for USP-NF documentary standards development related to impurities. In addition, the incumbent will contribute to the development of USP standards including monographs and general chapters for inclusion in the USP-NF..
Roles and Responsibilities
- Collaboratively leads cross-functional teams working with USP staff, USP volunteers, consultants, regulators, industry, and other external stakeholders to develop and advance USPs impurity strategy.
- Provides scientific direction and expert guidance on impurities strategy execution to USP’s Scientific and cross-functional leadership.
- Advocates effectively both internally and externally to align stakeholders and achieve consensus on approaches to impurities standards.
- Represents USP at scientific conferences/meetings, outreach visits and other events sponsored by USP and/or pharmaceutical industry and regulatory agencies.
- Develops new monographs and revises existing monographs based on expert evaluation and application of supporting data, monograph tests, procedures, and acceptance criteria.
- Prepares manuscripts for publication by USP (e.g., stimuli articles) or in peer-reviewed journals.
- Participates in the development and/or review of USP’s professional education course materials and may serve as an instructor, as needed.
- Principal Scientist: D. in Chemistry, Biochemistry or allied field with a minimum of 10 years of relevant experience; or MS with 12 years
- Senior Principal Scientist: D. in Chemistry, Biochemistry or allied field with a minimum of 13 years of relevant experience; or MS with 12 years
- Broad pharmaceutical industry experience in CMC development of active pharmaceutical ingredients and drug products with significant experience in the control of pharmaceutical impurities.
- Expert knowledge on the establishment of control strategies for all classes of impurities in pharmaceutical drug substances and drug products, including mutagenic impurities.
- Strong knowledge of modern analytical techniques including their development, validation, and application to the testing of pharmaceuticals, such as HPLC.
- Knowledge of global regulatory requirements and guidance (e.g. FDA, ICH, etc.) relevant to pharmaceutical products
- Able to lead and coordinate high performing cross-functional teams. Able to prioritize tasks and manage multiple projects simultaneously.
- Able to distill large amounts of information into executable strategies and workplans
- Able to adapt landscapes, strategies, and workplans based on organizational/stakeholder needs and constraints
- Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills.
- Must be able to share technical information with non-technical or non-scientific staff, and to communicate effectively with representatives from pharmaceutical companies, government, and academic institutions.
- Able to establish and nurture relationships with individuals of varying backgrounds, cultures and learning styles.
- Able to operate independently yet understands when to escalate issues and how to establish effective working relationships.
- Strong presentation and communication skills (written and oral).
- Expertise in site-to-site transfer of methods and method equivalency.
- Experience authoring reports for the CMC section of the CTD used for IND or product applications for global submissions a plus.
- Experience with advanced manufacturing technology (AMT), process analytical technology (PAT) a plus.
- Experience with the development and/or commercialization of complex generics products a plus.
- Expert knowledge of organic chemistry especially with regards to formation of impurities 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.