The U.S. Pharmacopeial Convention (USP) Associate Director - Compendial Development Laboratory in Hyderabad, India
Summary of the Position
This is a supervisory position responsible for the modernization of monographs included in USP-NF, the development of new monographs/ iterative standards and providing support to general chapters. The incumbent in this role will be responsible for supervising different teams involved in the development and validation of analytical methods for small molecules (drug substances and drug products) and Excipients. Support to development/ modernization of monographs for FCC and supervision of team involved in Food ingredients may be required occasionally. The responsibilities in this position include supervising the entire life cycle (lab request, procurement, execution, and reporting) of monograph modernization/ new monograph development/ iterative standards/ general chapter projects. This position will directly impact USP’s mission of strengthening the global supply of quality medicine and becoming a definitive source of quality standards. The incumbent in this position needs to coordinate with internal customers such as Scientific Liaisons (SLs), CDL Specialists for ensuring strong project pipeline and other support functions such as procurement and quality assurance (QA).
Roles and Responsibilities:
Responsible for assigning projects to the teams and ensuring the timely execution of the projects.
Supervise and guide the teams in reviewing the lab request, and assessing the project scope, materials required, and project planning.
Supervise the team in coordinating and providing technical assistance to the procurement team for procuring the required materials for the assigned projects according to the sample acquisition request submitted by internal customers (Scientific Liaisons)/ PUT/ program and project coordinator.
Tracking the projects submitted by internal customers (SLs)/ PUT/ program and project coordinator. Arranging kick-off meetings to discuss on scope and timeline of the projects with SLs.
Supervise and guide the team members in the execution and report preparation (method development and validation) of the projects according to the operation manual.
Reviewing the final reports and ensuring timely completion of the projects according to the lab requests.
Ensuring timely circulation of the final reports to the internal customers (SLs) and quality assurance and addressing their comments.
Communicate and interact actively with global teams on project updates and other activities.
Participate and contribute to various on-site and global initiatives which are rolled out on a time-to-time basis.
Providing monthly inputs on the overall status of the projects (on-bench, procurement, completed) for the compilation of monthly reports/ status.
Identifying the training needs of the team members and coordinating with the supervisor to ensure staff is appropriately trained based on the job requirements.
Responsible for the overall quality compliance and coordinating with QA for all the necessary documentation required for maintaining the QMS system (ISO 9001 and ISO17025).
Guide team and provide support during internal and external quality audits.
Act as an internal QA coordinator of the department performing regular walkthroughs and check-ins for ensuring quality compliance.
Supervise and guide the team members to ensure the implementation of the quality management system (SOP, deviations, change controls, etc.,).
Should have hands-on experience in chromatography (HPLC, GC), mass spectrometry (LC-MS/MS, GC- MS/MS, HRMS, FTIR, Raman) techniques, and other wet chemistry techniques.
Should have experience in method development and validations (DS/ DP/ Excipients/ Food ingredients).
Supervise and guide the team for regular in-house maintenance of the instruments ensuring minimum downtime and optimum performance.
Ensure proper preventive maintenance of the instruments and scheduled periodic calibrations (review of calibration, IQ/OQ/PQ documents).
Responsible for introducing innovative strategies/ approaches for improving operational efficiencies and ensuring the cost-effectiveness of the projects.
Responsible for practicing and encouraging Diversity, Equity, Inclusiveness, and Belonging (DEIB) within teams and departments.
Actively participate in Global initiatives and ensure encouraging team members for active participation.
Provide support to EHS and ensure implementation of safety procedures.
Support other stakeholders (such as USP education, External affairs, etc.) Basic Qualifications
Ph.D. degree in Chemistry or Pharmacy or a relevant field.
Minimum of fifteen (15) years of experience in the field of analytical method development and validations for API and different dosage forms. Preferred Qualifications
Ph.D. in Chemistry (Analytical) or Pharmaceutical Sciences with at least 15 years of experience in a relevant field.
Experience in handling teams working on multiple projects.
Hand-on knowledge of USP General Chapters and monographs and other pharmacopeias.
Knowledge and exposure to analytical QbD approach of method development.
Excellent written, and verbal communication and presentation skills.
Technical and analytical skills required including the ability to interpret technical information.
Must have hands-on experience in handling instruments like HPLC, UHPLC, LC-MS, GC, GC-MS, IC, ICP-OES/MS, Dissolution, FTIR, UV-Visible, etc.
Knowledge and exposure of handling different dosage forms, complex generics and Extractables and Leachables is preferred.
Must have experience working in a GMP environment and have exposure to regulatory guidelines.
Ability to handle multiple priorities in a fast-paced environment.
Job Category Chemistry & Scientific Standards
Job Type Full-Time