The U.S. Pharmacopeial Convention (USP) Senior Scientific & Standards Liaison in Hyderabad, India
Roles and Responsibilities
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.
Plans and oversees necessary laboratory work for method development and verification, and reference standard evaluations as needed.
Communicates and maintains working relationships with other USP departments regarding projects related to validation studies, methods development, reference standards, and other cross-cutting activities.
Keeps abreast of current trends and developments in related scientific fields, particularly in the areas of advanced therapies, genomics and vaccines.
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 (as assigned).
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.
Science and Standard Liaison:
Ph.D. degree in Biochemistry, Biology, Pharmacy, or a related field and eight (8) years, or Master’s degree and ten (10) years of relevant experience in analytical development for biotherapeutics/vaccines/advanced therapies that includes at least 5 years in a regulated biopharmaceutical environment.
Senior Science & Standards Liaison:
Ph.D. degree in Biochemistry, Biology, Pharmacy, or a related field and ten (10) years of relevant experience in analytical development for biotherapeutics/vaccines/ advanced therapies that includes at least 5 years in a regulated biopharmaceutical environment. An equivalent combination of experience and education may be substituted.
Experience with pharmaceutical and biotechnology product development and characterization for advanced therapies, genomics and vaccines.
Experience with reference materials development is a plus.
Experience with analysis of recombinant therapeutic proteins, peptides, carbohydrates, vaccines etc.
Experience with analytical techniques such as HPLC, CE, MS 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.
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.
Practical experience in scientific analytical techniques.
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.
Experience and knowledge of the USP-NF is preferred.
Job Category Chemistry & Scientific Standards
Job Type Full-Time