Compendial Development Laboratory Specialist
- United States
- 10 - 15 years
- Hyderabad
- 3 years ago
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Job Description
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.
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Proactively identify roadblocks and alerts GLTO management team to ensure strong project pipeline.
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Manage sample inventory changes coordinate with RMA/ procurement department to ensure availability of samples for initiation of projects in labs.
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Assist in developing models and analyzing work load capacity vs. demand in all areas of method / standard development projects
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Track, report and ensure milestones are met for Documentary Standards including New Use Testing, Early Procedure Evaluation, Collaborative Testing, CSUs etc.
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Collaborate with DSS and PPM staff to optimize and document development processes
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Update multiple, operation-critical reports.
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Create reports and presentations to communicate performance vs. targets for ADL/ CDL projects.
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Work toward automated generation of reports
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Perform in-depth root-cause analyses in case of weak project pipeline.
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Identify and report data trends that indicate opportunities for improved resource capacity management
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Create and deliver ad hoc reports, documents and presentations to GLTO staff
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Works with management and peers to develop, improve, and standardize project-related processes
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Supports cross-departmental and cross-divisional activities as related to ADL/ CDL projects
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Recognizes and escalates issues potentially requiring upper management awareness and input
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Manages, tracks, compiles forecasts and projections for ADL/ CDL projects.
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Creates presentations documenting USP s progress in Documentary Standards development.
- Provides assistance for special projects, upon request.
Basic Qualifications
- Bachelor s Degree with minimum of eight (8) years of relevant experience or an equivalent combination of training and experience.
Preferred Qualifications
- 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
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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
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Excellent critical thinking and problem solving skills
- Strong time management skills
- Strong organizational skills and attention to detail
- Excellent presentation and reporting skills
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Familiarity with scientific/technical terminology preferred.
- USP experience and/or experience in the pharmaceutical industry a plus.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area: IT Software - Application Programming, Maintenance,
Role Category: Project Management
Role: Project Management
Employement Type: Full time
Education
Under Graduation: Any GraduatePost Graduation: Any Postgraduate
Contact Details:
Company: United StatesLocation(s): Hyderabad
Keyskills: Validation Procurement Communication Skills Customer Service Problem Solving Adl Scientific Ms Project Method Development
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