Chemistry Senior Scientist Vacancy @ USP – Apply Online
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Job Title: Senior Scientist I – Doc and Reference Standards
Location: Hyderabad, India
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.
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.
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