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.
Post: Manager, Compendial Development Laboratory
Job Description
Function 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 supervisory position in the Compendial Development Laboratory (CDL) within Global Laboratory Operations. The incumbent will be responsible for guiding a team of scientists involved in USP/NF/OTC/DSC method development and method validation projects and maintaining safety and GLP environment in the lab. This position is a component of USP’s core business and the incumbent is expected to support monograph modernization initiatives.
Roles and Responsibilities:
- Supervise literature search, plan and execute compendial projects as per protocols, guidelines and established SOPs. The incumbent will be responsible for ensuring the output on development of modern, rugged and transferable methods.
- Ensure the projects requirements are met by coordinating with the supervisor and respective scientific liaisons by proving input to run the activities.
- Engage in project planning, execution, method development and validation of projects according to set standards as USP general chapters, guidelines, SOPs and protocols.
- Monitor each stage of development closely and coordinate with supervisor to complete the projects within time.
- Responsible for review of the records and documents and archival of projects records. In addition, facilitate peer review system and provide unbiased feedback on data and reports.
- Responsible for preparation and review of SOPs, Protocols, reports etc.
- Ensure that the calibrations of the equipment are performed as per the schedule and take part in preparation, execution and completion of IQ/OQ/PQ for new instruments.
- Indent the required glass ware, chemicals and columns for the projects and guide the lab ERP coordinator to maintain the inventory of chemicals and LC columns.
- Work professionally and collaboratively with fellow lab scientists, scientific liaisons, and other relevant departments in the review and development of documentary standards.
- Implement and maintain key quality systems such as deviations, investigations, and CAPA’s Maintain GLP & safety procedures while working in Lab.
- Identify and implement solutions to technical problems related to the development and analysis of the data.
- Monitor the projects steps such as inward, under process, archival, disposal, etc. and review the records.
- Assist in target setting process and appraisals of the team with the supervisor.
- Co-ordinate with supervisor to identify training needs of the team & take training classes.
- Provide hands-on training to the new joiners and existing scientists, and ensure that the team follows USP Policies and Procedures.
- Coordinate with HR, Purchase, Accounting, departments for related activities.
- Plan and coordinate for ISO-9001 and ISO/IEC17025 audits and related activities, and respond to QA observations.
- Demonstrate initiative with ability to navigate through project unknowns and complex situations.
- Strong leadership, stakeholder management, conflict resolution, communication and organization skills.
- Advanced critical thinking and problem solving skills and possess high accountability and drive for results.
- Demonstrated ability to understand and deliver on scientific and business objectives.
- Capable of concurrent big-picture understanding and strong attention to detail
- Able to effectively prioritize and efficiently manage multiple programs and versed with project management tools.
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Required Skills
Education and Experience:
Ph.D. Degree in Chemistry (Organic / Analytical) or Pharmaceutical Sciences with 8-10 years of experience. Possess a fine understanding of USP’s monographs/general chapters/general notices. Able to handle a team of talented scientist and motivate them for high productivity and quality work. 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 APIs and Formulations. Should have exposure to GMP/GLP environment and documentation procedures. Awareness of ISO/IEC 17025 is desirable.
Knowledge, Skills and Abilities:
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 fair understanding of GLP regulations and exposed to external regulatory audits. Working knowledge of computer applications, such as MS Word and MS Excel and exposure to lab software such as e-LNB, NuGenesis, Autochrome, Zenith, Empower, and PPM tools would be advantageous.
Frequent Contacts:
All Laboratory Staff, Vice President- R&D, Director – CDL Lab, Director and Staff– Lab Operations, Director and Staff – QA, and other internal staff.
Additional Information:
Experience: 8-10 years
Tracking Code: 406-679
Location: Hyderabad, Andhra Pradesh, India
Education: Ph.D. Degree in Chemistry (Organic / Analytical) or Pharmaceutical Sciences
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: QA
End Date: 10th September, 2015
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