The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities 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 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Post : Senior Scientist II, Documentary Standards
Job Description
Brief Job Overview
This is a hands-on, non-supervisory, non-laboratory role in the India Biologics department. The incumbent will support the reference standard program within the Global Biologics department. The incumbent in this role will focus on supporting the suitability program, including preparing and reviewing CSU testing protocols, providing technical assistance to testing labs, reviewing analytical data and preparing summary reports to assist in confirming the continued suitability of USP Reference Standards (RS). The incumbent will also participate in the development of replacement and new reference standards /ARM in support of USP’s Mission and core business.
Roles and Responsibilities
• Works with key stakeholders to develop reference standards for biotechnology pharmaceutical products including proteins, peptides, heparins, antibiotics, and advanced therapies.
• Oversees and facilitates the development of standards and solutions to address analytical challenges associated with biological medicines.
• Supports day to day operations of the Stability program covering the USP Biologics RS catalog inventory.
• Reviews testing history and drafts test protocols for lab submission based off designated testing requirements and schedules.
• Assists laboratories to ensure testing is completed accurately and in timely manner.
• Reviews laboratory reports, evaluates results and compares to previous data and RS attributes to assess and conclude on RS suitability for use.
• Compiles current and historical data and summary assessment into Stability testing and trending reports.
• Maintains and updates various databases documenting laboratory data and program determinations on suitability and Stability interval updates.
• Supports the RS Laboratory, Quality Assurance and Reference Standard Evaluation with investigation of unexpected stability testing results.
• Works collaboratively with various USP departments as needed on test planning, data impact assessments and appropriate determination of next steps.
• Reviews protocols and/or reports of other Scientists as assigned by manager.
• Responds to stakeholder inquiries pertaining reference standards.
Candidate Profile
• 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 Biochemistry, Analytical Chemistry or Biological Sciences . Minimum of 7 to 10 years of post-educational work experience in recombinant therapeutic proteins, peptides and carbohydrates. (or )
• MSc. in Biochemistry, or Biological Sciences with minimum of 11 to 13 years of commensurate industrial experience.
• Hands-on experience with analytical techniques of recombinant therapeutic proteins, peptides, gene therapy, vaccines and carbohydrates, such as HPLC, LC-MS, CE, cIEF, ELISA, SPR, ddPCR/qPCR.
• 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.
• Excellent technical writing and oral communication skills required.
• Must be able to communicate effectively with both internal and external customers.
• Knowledge of USP products and services highly desirable.
• Operates collaboratively at all levels of the organization in a highly technical environment.
• Must be able to work in a fast-paced environment and respond to shifting priorities.
• Well-developed interpersonal, negotiation and listening skills.
• Must possess the ability to multi-task and to work effectively with a team.
• Takes personal responsibility to ensure work is delivered on time and is of the highest possible quality.
• Experience working in the compendial, pharmaceutical and/or biotechnology industry strongly preferred.
Additional Information
Experience : 5+ years
Qualification : MSc or Ph.D. degree
Location : Hyderabad, IND
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Documentary Standards
End Date : 30th December 2024
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