The U.S. Pharmacopeial Convention (USP) Team Lead, Principal Scientist in Hyderabad, India
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.
Brief Job Overview
This is a supervisory management as well as individual contributor role that serves as the liaison between the biopharmaceutical industry, regulatory agencies, USP departments and USP Expert Committees. The Liaison facilitates the development of the USP documentary standards and reference 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, Oligonucleotides and carbohydrates, 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?
Roles and Responsibilities
Lead, manage and perform supervisory role to ensure delivery of projects towards development of Reference Standards, Documentary Standards, new initiatives in Biologics, outreach and USP's programs and services.
Direct, manage and mentor staff as assigned. Perform supervisory role such as goal setting, performance review, staff development and career counselling.
Responsible for monograph development, revision and reference standard development for USP-NF. Plans collaborative studies and data compilation and report preparation of the collaborative study.
Responsible for preparing all the technical documents necessary for the reference standard development which includes collaborative study test kit documents, RSCEP etc.
Works with key stakeholders to develop new and innovative standards for biotechnology pharmaceutical products including advanced therapies, genomics and vaccines.
Oversees and facilitates the development of standards and solutions to address analytical challenges associated with the next generation of biological medicines.
Develop relationships and partnerships with key stakeholders, within the research, manufacturing and regulatory communities.
Writes general and specific subject correspondence pertaining to documentary standards, reference materials, and various USP policy issues. Evaluates and analyzes scientific reports and supporting validation data and translates specifications and test methods into USP documentary standards.
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.
Takes part in EP and EC meetings as required. Provides assistance in conducting Expert Committee and Panel meetings.
Serves as representative of USP at professional scientific meetings organized by USP and other organizations.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, as needed.
Designs and oversees the execution of collaborative testing once a candidate material has been sourced. Prepares data summary and analysis from collaborative studies.
Participate in education activities like PE courses as course developer, reviewer and course instructor.
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:
• MSc/Ph.D. in Biochemistry/Biotechnology/Life Sciences or any related stream with deep domain knowledge and strong practical skills working with Biologics product class for more than 20 years of work experience. The candidate should have minimum of 10 years of people/team management experience and excellent collaboration skills to interact and work with global teams.
• A comprehensive understanding of the science involved in the development of biopharmaceutical standards and reference materials is required.
• Hands on experience with analysis of recombinant therapeutic proteins, peptides, carbohydrates, vaccines, CGT etc. Experience with analytical techniques such as HPLC, CE, MS, GC, SEC -MALS, CD, SPR and advanced PCR technology is desired
• Ability to write technical reports related to material characterization, references standard evaluations, and method development
• Experience in method development and characterization of products and impurities using a variety of physicochemical techniques and biological assays
• Knowledge of the pharmaceutical industry and the associated regulatory framework is essential
• Deep Knowledge and experience in analytical R&D and molecular characterization of Biologics along with implementation of QMS is essential, understanding of Compendial requirements and has had a track record of delivering on the same.
• Proven track record in leading and managing team of scientists besides excellent collaborative, interpersonal and coordination skills is essential. Excellent technical writing and verbal communication and presentation skills are required.
Additional Desired Preferences
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.
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.
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.
Additional Desired Preferences
Job Category Chemistry & Scientific Standards
Job Type Full-Time