Scientist II, ARD (PREP HPLC)

Description

Who is USP?

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.The U.S. Pharmacopeial Convention (USP) is an independent scientific organization.

At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare.

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—an environment where every employee feels fully empowered and valued irrespective of, but not limited to, 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 for individuals with disabilities

Brief Job Overview

This is a non-supervisory position to support development of Reference materials. The successful applicant in this role will work on projects including isolation/ purification for synthetic lab and compendial development lab projects. The successful candidate will also work on isolation/ purification of known and unknown impurities/compounds by preparative HPLC and maintain safety & GLP environment in the lab.

How will YOU create impact here at USP?

In this role at USP, you contribute to USP's public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments

The Scientist II Has The Following Responsibilities

• [60%] Execute the Isolation projects. Support to reaction monitoring, scale up and final analysis of samples as per monograph / in-house procedures including method development if required. Prepare development reports for Synthetic Support projects. Involve in project acceptance.
• [15%] Prepare, execute, and complete IQ/OQ/PQ of new instruments. Indent the required glass ware, chemicals, and columns for the ARD projects. Maintain GLP & implement safety procedures while working in Lab. Perform other Projects whenever free from ARD activities. Perform other duties as assigned.
• [10%] Responsible for preparation of SOPs, protocols, reports, etc. Ensure the projects requirements by coordinating with the Purchasing department. Responsible for preparation of the records and documents. Ensure that the calibrations of the equipment’s are performed as per the schedule.
• [10%] Preparation and planning for ISO-9001 certification/recertification by participating actively, verification of protocols and related documents and take an active role in the internal as well as external QA audits and address the audit issues in a timely manner. Taking up any other additional responsibilities assigned by supervisor on a proactive basis and allotting additional responsibilities to the reporting staff in consultation with the supervisor. Participates in USP cross-functional teams as appropriate.
• [5%] Practice Diversity, Equity, Inclusion, and Belonging principles at USP India.
  
  

Who is USP 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. in Analytical Chemistry / Organic Chemistry/M. Pharm, having 3-6 years of experience in Analytical Research and Development.
• Must have hands on experience in working with chemical methods and handling instruments like Preparative HPLC, HPLC, FTIR, wet chemistry, etc.
• Must have experience in HPLC method development.
• Experience in analytical testing and development with focus on process analytical chemistry. Exposure to GMP/GLP environment and documentation procedures required.
• A comprehensive understanding of the science involved in the development of synthetic organic molecules and analytical chemistry.
• Excellent technical writing and verbal communication skills are required.
• Good interpersonal skills and proven ability to function in a team-oriented environment are necessary.
  
  

Additional Desired Preferences

• Knowledge of handling LCMS and other spectroscopic techniques will be an added advantage.
• General chapter information, ELN, Empower and NuGenesis will be an added advantage.
• Able to communicate effectively with both internal and external customers. Preferably familiar with electronic notebook documentation of experimental procedures.
• Good interpersonal skills and proven ability to function in a team-oriented environment are necessary.
• Desired preferences are to showcase any additional preferred levels of expertise to perform the role. Supervisory Responsibilities NA Benefits USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.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
  
  

Job Category Chemistry & Scientific Standards

Job Type Full-Time