The United States Pharmacopeia (USP) is a non–governmental, official public standards–setting authority for prescription and over–the–counter medicines and other healthcare products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years.
Post: Director - Analytical Research and Development (MC)
Job Description:
Function of the Position:
This is a supervisory position in which the incumbent is responsible for overseeing the Analytical Research and Development (ARD) laboratory facilities which includes analytical method development and compendial analytical method validation, as well as managing all daily operations of the ARD Lab. To lead and manage USP-India’s ARD Laboratory to promote good quality therapeutic products globally. USP India is a self-sufficient unit conducting business and science activities as part of USP’s global public health mission. The specific area is to make significant contributions to the credibility and enforceability of USP and NF standards; energizes and establishes a science-based culture of quality and productivity.
Job Duties:
• Responsibilities for ensuring that Lab adheres to USP’s mission, goals, objectives of the organization.
• Responsible for creating and managing a self supporting unit aligned with USP corporate culture, mission, and public health programs.
• Coordinates technical support with the home office for the USP-NF and USP reference standards in India/South Asia.
• Develops annual budgets, and projects resources, capital, personnel needs for the organization, and operation and maintenance of ARD laboratory.
• Implements laboratory budget, including expenses for personnel, travel, supplies, and capital expenditure.
• Coordinates with HR to recruit laboratory personnel to ensure full staffing and performance.
• Ensures productivity and quality of laboratory work.
• Develops staff and succession plans to meet the business needs of the organization.
• Participates on committees and task forces for strategic planning of the organization
• Directs efforts of the laboratory in development of reference standards and development and validation of analytical methods.
• Establishes and monitors priorities consistent with the organization’s priorities.
• Develops and implements research and development strategies and program definition subject to USP Reference Standards Committee policies through coordination with the USP Headquarters, Rockville, MD, USA.
• Overall responsible for the ARD activities, with a team of scientists.
• To review the Project requirements e & to give approvals.
• To complete the ARD Projects within timelines.
• Responsible for preparation/review and implementation of SOPs, Protocols, reports etc.
• Responsible in executing the development & validation reports for ARD projects.
• To plan for ISO-9001 & ISO-17025 Recertification Verification of Protocols
• To identify the training needs of the team & to take up some training classes.
Candidate profile:
Ph.D in Analytical Chemistry with not less than 12 years of working experience in the field of analytical research and development, which includes method development and validation. Should have thorough knowledge and exposure to implement and maintain GMP/GLP environment and documentation procedures.
Knowledge, Skills, Abilities:
Broad experience working for a research and development labs, in a multinational pharmaceutical company is desirable. Having prior experience in setting-up new laboratory and thorough knowledge in implementing Quality Management Systems is desirable. Must have hands on experience in guiding a team of chemists who handles various analytical instruments like HPLC, GC, FTIR, UV-Visible etc. Should have strong interpersonal skills with technical writing and verbal communication skills are a must. Must be able to communicate effectively with both internal and external customers. Working knowledge of computer applications, such as MS Word and Excel are required. Proven leadership and staff management skills a must.
Additional Information:
Experience: min. 12 years
Location: Hyderabad-India
Education: Ph.D
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
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End Date: 20th Sept, 2012
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