Scientist III, Analytical Research and Development

The U.S. Pharmacopeial Convention (USP) is a scientific non-profit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. USP promotes Diversity & Inclusion at Workplace and encourages Equal Employment Opportunity and Affirmative Action

This is a non‐supervisory position in USP‐India’s Analytical Research & Development Laboratory. In this role, the Scientist‐III works on Synthetic R & D and Collaborative projects as per ISO/IEC‐17025. The Scientist‐III performs a variety of non‐routine and routine analytical tests, including evaluation of reference standards, ensure the projects requirements by Coordinating with the supervisor and general research in analytical chemistry

Roles and Responsibilities

 Prepare for & execute the Synthetic R & D and collaborative testing projects as per ISO/IEC 17025.

 Ensure the projects requirements by Coordinating with the supervisor
 Ensure the availability of chemicals, standards and test licenses.
 Involve in project acceptance & approvals.
 Execute projects per the approved test protocols if assigned.

 Responsible for preparation of SOPs, protocols, reports, etc.

 Ensure the projects requirements by coordinating with the Purchasing department.

 Complete ARD‐ (USP‐NF & CDL) and collaborative testing projects within timelines by coordinating with Manager.

 Responsible for preparation of the records and documents.

 Ensure that the calibrations of the equipment’s are performed as per the schedule.

 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

 Preparation and planning for ISO‐9001 & ISO‐ 17025 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.

 Participates in USP cross‐functional teams as appropriate

Required Skills

• Proficient with pharmaceutical testing requirements involving compendial methods for reference materials.
•  Expert in HPLC and GC analysis and troubleshooting, proficient in other related analytical instrumentation (IR, KF, UV, and thermal analysis techniques etc.).
•  Knowledge of handling LCMS and GCMS will be added advantage.
•  Working knowledge of computer applications, such as MS Word and MS Excel are required.
•  Good interpersonal skills and proven ability to function in a team‐oriented environment are necessary.
•  Proven track record of consistently delivering projects on time and with high quality.
•  Prior experience in a high volume pharmaceutical ARD laboratory or contract pharmaceutical analytical laboratory testing organization is a plus.
•  Takes personal responsibility for delivery of projects to customers.
•  General chapter information, Empower and NuGenesis will be preferred.

Required Experience

•  M.Sc. in Analytical Chemistry / Organic Chemistry, from a well‐recognized University in India or abroad and required not less than 6‐8 years’ experience in Analytical lab.
   Must have hands on experience in working with chemical methods and handling instruments like HPLC, GC, FTIR, UV‐Visible, wet chemistry, etc. Must have experience with electronic notebook documentation of experimental procedures (LMS) and QMS system.
   Good technical writing and verbal communication skills are required. Good interpersonal skills and proven ability to function in a team‐oriented environment are necessary. Understanding of GMP / ISO‐IEC 17025 Guidelines is a requirement