U.S. Pharmacopeial Convention Hiring Senior Scientist

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 I, Documentary Standards (Biologics)

Job Description
This is a hands-on, non-supervisory, non-laboratory role in the India Biologics department. The incumbent work collaboratively in the reference standard/ARM development program within the Global Biologics department. The incumbent will participate in the development of replacement and new reference standards /ARM in support of USP’s mission and core business. The incumbent will also 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 need to be excellent team player with good collaboration/Liaising skills to complete assigned projects in timely manner.

Roles and Responsibilities
• Maintain smooth collaboration and works closely with key stakeholders across the globe to develop reference standards for biotechnology pharmaceutical products including proteins, peptides, heparins, antibiotics, and advanced therapies.
• Works to draft protocols, reports and address scientific and technical queries from internal and external stakeholders in timely manner pertaining to reference standards/ARMs
• 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 (CSU) program covering the USP Biologics RS catalog inventory.
• Reviews RS testing history and drafts test protocols for collaborative studies and CSU studies and submits to labs based on designated testing requirements and schedules.
• Liaisons and Assists laboratories to ensure collaborative testing/CSU 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 Stability testing data assessment and prepare stability trend reports.
• Maintains and updates various databases documenting laboratory data and program determinations on suitability and Stability interval updates.
• Filing and closure of QMS elements as per QMS system when required and 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.
• Prepare, present and discuss regular work updates with Team Lead and other team members
• Reviews protocols and/or reports of other Scientists as assigned by manager.

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:

Preferred Qualifications
• Hands-on experience with state-of-the-art analytical techniques for the characterization of recombinant therapeutic proteins, peptides, gene therapy, vaccines and carbohydrates, such as UPLC/HPLC, LC-MS, CD, Fluorescence spectroscopy, FTIR, DSC, SEC-MALS, CE-SDS (Reducing and Non-reducing), icIEF, ELISA, SPR, ddPCR/qPCR etc.
• Strong ability to evaluate and compile analytical testing data, ability to write technical reports related to material characterization, references standard evaluations, and method development.
• Demonstrated experience in analytical method development, method qualification/validation and characterization of biological products and impurities using a variety of physicochemical techniques and biological assays.
• Excellent technical writing, presentation and oral communication skills are required.
• Must be excellent team player and able to work amicably and communicate effectively with both internal and external stakeholders.

Sr. Scientist I
• 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.
• in Biochemistry, or Biological Sciences with minimum of 11 to 13 years of commensurate industrial experience.

Additional Desired Preferences
• Knowledge of USP products and services is 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, conflict-resolution and listening skills.
• Must possess the ability to multi-task and to work effectively with a team.
• Takes ownership and 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 : 7 to 10 years
Qualification : Ph.D. degree in Biochemistry, Analytical Chemistry or Biological Sciences
Location : Hyderabad, IND
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Documentary Standards (Biologics)
End Date : 30th June 2025