The U.S. Pharmacopeial Convention (USP) Compendial Development Laboratory Specialist in Hyderabad, India
Summary of the position
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.
This is a hands-on, non-supervisory position responsible for planning, coordinating, and ensuring consistent flow of standard development projects for ADL/ CDL staff globally. The incumbent is responsible for project activities which collaborates with small molecules PUT to identify and follow up on projects to fill the project pipelines. The incumbent helps monitor the progress, completion and release of method development and validation reports for development of documentary standards. This position will directly impact USP’s Analytical/ Compendial Development Laboratory projects. The incumbent will also coordinate reporting, analyze data, monitor project activities, provide status updates to various groups, and maintain documents and reports. The ideal candidate will be detail-driven, self-motivated, and able to work independently while collaborating effectively with colleagues at all organizational levels.
Roles and Responsibilities
Coordinate with internal stakeholders to define process for selection of projects for ADL/ CDL in collaboration with small molecules PUT.
Proactively identify roadblocks and alerts GLTO management team to ensure strong project pipeline.
Manage sample inventory changes—coordinate with RMA/ procurement department to ensure availability of samples for initiation of projects in labs.
Assist in developing models and analyzing work load capacity vs. demand in all areas of method / standard development projects
Track, report and ensure milestones are met for Documentary Standards including New Use Testing, Early Procedure Evaluation, Collaborative Testing, CSUs etc.
Collaborate with DSS and PPM staff to optimize and document development processes
Update multiple, operation-critical reports.
Create reports and presentations to communicate performance vs. targets for ADL/ CDL projects.
Work toward automated generation of reports
Perform in-depth root-cause analyses in case of weak project pipeline.
Identify and report data trends that indicate opportunities for improved resource capacity management
Create and deliver ad hoc reports, documents and presentations to GLTO staff
Works with management and peers to develop, improve, and standardize project-related processes
Supports cross-departmental and cross-divisional activities as related to ADL/ CDL projects
Recognizes and escalates issues potentially requiring upper management awareness and input
Manages, tracks, compiles forecasts and projections for ADL/ CDL projects.
Creates presentations documenting USP’s progress in Documentary Standards development.
Provides assistance for special projects, upon request.
- Bachelor’s Degree with minimum of eight (8) years of relevant experience or an equivalent combination of training and experience.
Bachelor’s Degree with 10-15 years of relevant experience or an equivalent combination of training and experience. Science degree is preferred.
Superior interpersonal skills: professionalism, accountability, helpfulness, delegation, and customer service
Excellent facilitation, conflict resolution, and team building skills in the management of cross-functional teams
Comfortable working with internal and external professionals.
Demonstrated ability to successfully manage multiple concurrent projects in a timely manner.
Advanced computer competence (MS Office programs, MS Project or similar)
Excellent verbal and written communication skills
Excellent critical thinking and problem solving skills
Strong time management skills
Strong organizational skills and attention to detail
Excellent presentation and reporting skills
Familiarity with scientific/technical terminology preferred.
USP experience and/or experience in the pharmaceutical industry a plus.
Job Category Chemistry & Scientific Standards
Job Type Full-Time