Job Information
The U.S. Pharmacopeial Convention (USP) Senior Scientist II, Documentary Standards in Hyderabad, India
Description
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 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, to the partnerships we build, to the conversations we foster, we affirm the crucial value of Diversity, Equity, Inclusion and Belonging in building a world where everyone can be confident of quality in health and healthcare.
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, 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.
Brief Job Overview
This position is a non-supervisory hands-on, technical role that supports the standard-setting activities of the USP-NF. The incumbent is responsible for revising and developing new USP-NF monographs for drug substances and drug products working in close collaboration with USP’s Small Molecules Expert Committees and our volunteers.
How will you create impact here at USP?
Oversees and facilitates all aspects of the development of documentary Standards for the USP-NF. Evaluates and analyzes supporting data and converts into USP style and format.
Collaborates with stake holders and sponsors for development of Documentary Standards.
Assists in the activities of the USP Expert Committees and Expert Panels, as needed.
Communicates and collaborates with USP departments on documentary standards development topics.
Participates in the development and/or review of USP’s professional education course materials and may serve as an instructor.
Provides general scientific-related support to other scientific and managerial staff.
Responds to inquiries pertaining to USP-NF monographs and General Chapters.
Writes general and specific subject correspondence pertaining to USP standards.
Keeps abreast of current trends and developments in related scientific fields.
Communicates and collaborates with USP Laboratories regarding projects related to validation studies, method development, and reference standards.
Serves as representative of USP at professional meetings (scientific meetings organized by USP and other organizations, meetings at other pharmacopeias or regulatory agencies etc.). Gives public presentations on USP matters (as assigned)
Performs other related duties as required.
Who USP is Looking For?
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
The candidate must have strong analytical chemistry knowledge with the ability to review, analyze, interpret and report effectively on data from a variety of analytical instrumental tests (e.g., GC, HPLC, NMR, ICP, AA, KF, UV, LC/MS, GC/MS). Well-developed organizational and interpersonal skills. A strong communicator (written and verbal) able to share information with scientific and non-technical staff and external stakeholders from the pharmaceutical industry, government, and academic institutions. Able to establish and nurture relationships with individuals of varying backgrounds, cultures and learning styles.
Experience Required:
Senior Scientist I: MSc with minimum 11 to 13 years relevant experience; or Ph.D. degree in Chemistry, Biochemistry, or a related scientific field with 7 to 10 years.
Senior Scientist II: MSc with minimum 13 to 15 years relevant experience; or Ph.D. degree in Chemistry, Biochemistry, or a related scientific field with 10 to 13 years
Additional Desired Preferences
Broad pharmaceutical industry experience in CMC development of active pharmaceutical ingredients and drug products.
Experience authoring reports used for ANDA/NDA or product applications for global submissions a plus.
Strong knowledge regarding the development, validation, and application of modern analytical techniques to the testing of pharmaceuticals.
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 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.
Expert knowledge on risk assessment and the establishment of control strategies for all classes of impurities in pharmaceutical drug substances and drug products a plus.
Supervisory Responsibilities
No
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.
Job Category Chemistry & Scientific Standards
Job Type Full-Time