The U.S. Pharmacopeial Convention (USP) Senior Scientist I - Doc and Reference Standards in Hyderabad, India
Brief Job Overview
This is a hands-on, non-supervisory role that serves as the liaison between the biopharmaceutical industry, regulatory agencies, USP departments and USP Expert Committees. The Sr. Scientist facilitates the development of USP standards used by the global pharmaceutical industry. In this role, the incumbent will provide expertise, leadership, and guidance to USP Expert Committees and Expert Panels in the areas of therapeutic proteins, peptides, and vaccines, by facilitating the exchange of highly technical information and working collaboratively to improve and promote public health.
How will YOU create impact here at USP?
Works with key stakeholders to develop new and innovative standards for biotechnology pharmaceutical products including therapeutic proteins, peptides, and vaccines.
Oversees and facilitates the development of standards and solutions to address analytical challenges associated with the next generation of biological medicines.
Plans and oversees necessary laboratory work for method development and verification, and reference standard evaluations.
Communicates and maintains working relationships with other USP departments regarding projects related to validation studies, methods development, reference standards, and other cross-cutting activities.
Responds to stakeholder inquiries pertaining to USP-NF documentary and reference standards.
Serves as representative of USP at professional scientific meetings organized by USP and other organizations. Gives public presentations on USP matters.
Prepares standards proposals and provides assistance, as needed, for the USP Expert Committees and Expert Panels of the Council of Experts – e.g., helps with the development of monograph proposals for decision, provides requested background information and coordinates laboratory work.
Designs and oversees the execution of collaborative testing, once a candidate material has been sourced. Prepares data summary and analysis from collaborative studies.
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:
· Ph.D. degree in Analytical Chemistry, Biochemistry, or Biological Sciences . Minimum of five (5) years of post-educational work experience in bioanalytical development for biotherapeutics.
· MSc. in Analytical Chemistry, Biochemistry, or Biological Sciences with minimum of 10 years of commensurate industrial experience.
Experience with pharmaceutical and biotechnology product development and characterization
· Hands-on experience with bioanalytical technologies, such as HPLC, LC-MS, CE, ELISA, and qPCR
· Preferable experience with analytical techniques of recombinant therapeutic proteins and/or vaccines
Additional Desired Preferences:
Ability to write technical reports related to material characterization, references standard evaluations, and method development.
· Knowledge of the pharmaceutical industry and the associated regulatory framework is essential.
· Knowledge of national and international regulatory filings approaches. Familiarity with regulatory guidance documents from WHO, FDA, ICH and other international organizations.
· Able to establish and nurture relationships with individuals of varying backgrounds and learning styles.
· Able to operate independently where appropriate, yet understands when to escalate issues and how to establish effective working relationships.
· Strong presentation and communication skills (written and oral).
· Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills.
· Project management skills. Must have ability to prioritize and manage multiple, concurrent projects with often long life cycles.
· 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. Ability to persuade corporations to collaborate with USP on various projects.
Supervisory Responsibilities: No
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 US
Job Category Chemistry & Scientific Standards
Job Type Full-Time