Are you a seasoned pharmaceutical scientist passionate about advancing global health standards? The U.S. Pharmacopeial Convention (USP) is seeking a Sr. Scientist I or II to lead efforts in developing rigorous standards for complex generics, with a special emphasis on inhalation products. Based in Hyderabad, India, this full-time role offers a chance to collaborate with experts worldwide, drive innovation in generic drug development, and contribute to safer medicines for all. If you have deep expertise in inhalation product characterization and a commitment to equitable scientific practices, this position could be your next career milestone in the pharma industry.
Key Responsibilities
As a Sr. Scientist I/II in Documentary Standards for Complex Generics, you’ll play a pivotal role in shaping USP’s standards for inhalation products and other complex generics. Your duties include:
- Describing, building, and advancing a vision and roadmap for Complex Generics, particularly inhalation products like metered dose inhalers and dry powder inhalers.
- Participating in cross-functional groups to focus on high-impact topics such as particle size analysis, spray pattern, plume geometry, dissolution, permeability, delivered dose, aerodynamic sizing, and fine particle fraction.
- Determining deliverables, requirements, and timelines for standards development, ensuring tight integration with internal teams and external stakeholders like industry, academia, and regulators.
- Executing the roadmap by advocating for inhalation product standards across scientific and regulatory communities.
- Staying updated on industry trends through seminars, conferences, and consortia meetings, and representing USP at events or via publications.
- Collaborating with USP departments to promote standards through education, training, consulting, and lab services.
- Engaging in capability-building activities, including training and knowledge-sharing on Complex Generics.
Qualifications and Experience
USP seeks candidates with a strong background in pharmaceutical sciences and a dedication to inclusive, equitable practices. For Sr. Scientist I, a Ph.D. in Organic, Analytical, Pharmaceutical/Formulation Chemistry or related field with 7-10 years of experience (or M.Sc./M.Pharm. with 11-13 years) in USP-NF standards is required. Sr. Scientist II requires Ph.D. with 10-13 years (or M.Sc./M.Pharm. with 13-15 years). Equivalent combinations of education and experience are acceptable.
Essential skills include:
- Direct experience in Complex Generics, especially inhalation products, ophthalmics, or complex injectables.
- In-depth knowledge of inhalation product characterizations, including particle size analysis, spray pattern, plume geometry, dissolution, permeability, delivered dose, aerodynamic sizing, and fine particle fraction.
- Excellent written and verbal communication skills, with a focus on scientific writing for the pharma industry.
- Strong interpersonal abilities to build relationships with stakeholders.
- Preferred: Experience in inhalation generic drug development, CMC regulatory requirements, project management, and recognition in the Complex Generics community.
Benefits at USP
USP offers comprehensive benefits to support your well-being, including company-paid time off, healthcare options, and retirement savings. As an equal opportunity employer, USP fosters an inclusive environment with equitable access to mentorship, professional development, and leadership opportunities, ensuring fair, merit-based processes for all.
How to Apply
Ready to make an impact? Apply now for Req ID: SENIO003064. Visit USP’s career page or Pharmabharat.org for more details and to submit your application. USP is committed to providing reasonable accommodations for individuals with disabilities.