Scientist II, CDL

Description

Roles and Responsibilities

• Literature search for the USP/NF projects.
• To ensure the projects requirements by coordinating with the Group Leader.
• To involve in project execution, method development and validation of USP/NF projects.
• To coordinate with Group Leader to complete the USP/NF projects within timelines.
• To ensure the knowledge on different drug products handling and samples preparations.
• To give training to the new joiner about USP/NF projects and provide support to junior staff.
• Ensure the project updates are provided to the supervisor on regularly
• Help for the team members to resolve technical challenges and criticalities.
• Complete the projects as per the time lines.
• Ensure that the calibrations of the equipment are performed as per the schedule.
• Coordinate with Group Leader for the procurement of samples, standards, chemicals, columns, glassware, etc. as per the need and availability.
• Prepare and review of relevant SOPs.
• Support and co-ordinate for completion of IQ/OQ/PQ for new instruments.
• Provide hands-on training to the new joiners and existing scientists.
• Plan and coordinate with Group leader for internal audits, ISO-9001, ISO17025 audits and related activities.

Basic Qualifications

• Master’s Degree in Chemistry with 4-6 years of experience. Possess a fine understanding of USP/NF/FCC monographs/general chapters/general notices. Exposure to GMP/GLP/QMS environment and documentation procedures and champions the data integrity. Should be capable of performing analytical method developments and method validations using modern techniques and protocols. Good analytical skills in handling method development and Validations for small molecules (drug substance, drug products). Should have exposure to GMP/GLP environment and documentation procedures. Awareness of ISO/IEC 17025 is desirable.

Preferred Qualifications

• Master’s Degree in Chemistry (Analytical/Organic) or Pharmaceutical Sciences with 4-6 years of experience or PhD with at least 2-4 years of experience in relevant field. Exceptional breadth of pharmaceutical industry experience. Excellent technical writing and oral communication skills required. Must be able to communicate effectively with diplomacy and enthusiasm. Technical and analytical skills required including the ability to interpret technical information. Must have hands on experience in working with chemical methods and handling instruments like HPLC, UHPLC, LC-MS, GC, GC-MS, IC, ICP-OES/MS, FTIR, UV-Visible. Should have good understanding of GLP regulations and exposed to external regulatory audits.

Supervisory Responsibilities

NA

USP offers an impressive benefits package, including:

• Comprehensive individual and family health insurance plans

• Annual Master Health check-up plans

• Generous paid holidays, vacation leave

• Transportation services for office commute.

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit 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.

Being a part of USP means belonging to a diverse culture made up of more than 1,000 talented professionals working together at five international locations. We share our expertise in science, IT, human resources, quality assurance, communications, administrative management, and more...all to support an overall mission dedicated to making a difference by providing standards and programs that help improve the quality of medicines, dietary supplements, and foods worldwide.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

Job Category Chemistry & Scientific Standards

Job Type Full-Time