U.S. Pharmacopeia (USP) is an independent, scientific, nonprofit organization that improves public health by setting standards for the identity, strength, quality, and purity of medicines, dietary supplements, and food ingredients that are manufactured, distributed and consumed worldwide. USP’s medicines quality standards are enforceable in the United States by the Food & Drug Administration, and these standards are developed and relied upon in more than 140 countries. Since its founding in 1820, USP has helped secure the quality of the American drug supply. Building on that legacy, USP today works with scientists, practitioners, and regulators of many nations to help protect public health worldwide. To learn more visit www.usp.org
Summary of the Position
- This is a supervisory position in Reference Standards Laboratory (RSL), responsible for technical review and delivering of Reference standard collaborative projects by managing a group of scientists, maintaining a GLP environment in the Laboratory. The incumbent will utilize his or her technical expertise, knowledge of pharmaceutical analysis in guiding and mentoring the team members for the qualification of Reference standards through efficient and effective laboratory operations.
Roles and Responsibilities
- Responsibilities for ensuring that Lab adheres to USP’s mission, goals, objectives of the organization.
- Lead the group and team leads to deliver the Lab projects following GLP and safety practices.
- Initial review, verification and approve the project related Test protocols and Test kits received from RSE/CSU departments in USP-Rockville and any other supporting work from another team on a needy basis.
- Accountable to deliver the project as per the timelines and troubleshoot the scientific aspects of the projects on a need basis.
- Responsible for the preparation and review of SOP’s protocols, completing IQ/OQ/PQ of new instruments.
- Ensuring that the chemicals and column etc. are available for the projects and forward the purchase requisitions.
- Ensure all lab safety and GLP practices are maintained in the lab and participate actively in the internal and external audits and certification.
- Allotment of tests to the individual scientists in the absence of team leader based on the priority of the projects.
- Monitoring the project progress from receipt, under Process, review, report, archival, Disposal etc.to ensure minimum turn-around time.
- To coordinate with Quality Assurance to ensure the review of projects within the timelines.
- 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 on a timely manner.
- Ensures productivity and quality of laboratory work by minimising Lab errors and close monitoring of the regular activities of the team.
- Develop and work on a succession plan by identifying, grooming, and encourage subordinates to take up additional responsibilities.
- Participate in strategic initiatives for process improvements and others as appropriate to improve morale, culture, and productivity of the team.
- Active participation in cross-functional support activities like conducting PE courses, development, and review of course content and speaker assignment in training initiatives.
- Taking up any other additional responsibilities assigned by the supervisor on a proactive basis and allotting additional responsibilities to the reporting staff in consultation with the supervisor.
Proficient in pharmaceutical analysis with in-depth knowledge of theoretical concepts in Active pharmaceutical ingredients (API). Exposure in techniques like HPLC, GC, Ion Chromatography, IR, KF, UV, DSC. TGA, sorption analyser, ICP MS, ICP-OES, etc. for hands-on experience and troubleshooting. Takes personal responsibility for the delivery of projects to customers. Must have handled a team of 15-20 scientists for at least 02 years. Must have exposure to ISO 9001 and ISO 17025 requirements. Ability to embrace, lead change helping colleagues to grow by sharing targeted, actionable feedback, and new insights regularly. Extremely adaptable and consistently delivers on goals and deadlines while maintaining a high level of quality and accuracy. Excellent communication skills, both written and verbal. Having knowledge of Empower software, ELN, ERP, QR coding system are added advantages. Prior experience in a high-volume pharmaceutical manufacturing QC laboratory or contract pharmaceutical analytical laboratory testing organization is a plus
- Ph.D., in Analytical/Organic Chemistry with a minimum of 12 years of relevant laboratory experience or
- Master’s degree in pharmaceuticals/chemistry with a minimum of 12-15 years of relevant laboratory experience.