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 - Therapeutic Protein & Microbiology
Job Description
Function of the Position:
This is a supervisory management position in which the incumbent applies scientific principles and practical laboratory experience to manage the Therapeutic Protein Group & Microbiology Laboratory and staff of the Biologics and Biotechnology Division of USP-India. Oversees daily operation of the laboratory and interactions with other USP departments, lead and manage the Protein and Microbiology Group to promote good quality therapeutic products globally.
Roles and Responsibilities:
- Responsible to ensure that lab adheres to USP’s mission, goals and objectives.
- Direct and conduct research in Bioanalytical and Bioassay relevant to public standards in the areas of Therapeutic proteins
- Proposes annual budgets, projects resources, capital and personnel needs for the Therapeutic Protein and Microbiology Groups
- Assist in the USP-MC activities for Monograph and Reference Standard development in the area of Therapeutic Proteins
- Coordinate different collaborative projects, training projects in the area of Therapeutic proteins and Microbiology both at National and International Level
- Assist VP in planning, implementing and evaluating laboratory procedures/systems
- Reviews data and edit reports from Therapeutic Protein and Microbiology groups
- Assist VP in expansion plan with proper recommendations
- Supervise staff as assigned. Performs supervisory duties such as performance reviews, objective setting, staff development, and career counseling
- Responsible for preparation/review and implementation of SOPs, Protocols etc.
- Participates in USP cross-functional teams as appropriate.
- Supports and helps improve the USP-India quality management system.
- Demonstrates a strong desire to continue learning and grow personal capability.
- Pursues, recommends and implements new approaches or processes to improve Group’s operations
- Performs other related duties as required
Required Skills
Minimum Requirements:
Ph.D. in Biotechnology, biochemistry, microbiology or related field with not less than 10 years of relevant experience, including demonstrated laboratory experience.
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Knowledge, Skills & Abilities:
A comprehensive understanding of the science involved in the development of Bioanalytical pharmaceuticals and reference materials. Broad experience in the analysis of proteins and glycoproteins, experience in the development and execution of bioassays, familiarity with tissue culture, microbial and immunological tests, and experience with method qualification and validation are required. Experience with compendial methods a plus. A basic understanding of the processes of the USP is desired. Some experience in the organization and facilitation of collaborative studies desirable. Excellent technical writing and verbal communication skills are required. Good interpersonal skills and proven ability to function in a team-oriented environment are necessary. Proven leadership and staff management skills a must.
Minimum Requirements:
Ph.D. in Cell Biology, Biotechnology, biochemistry or related field with not less than 10 years of relevant experience, including demonstrated laboratory experience.
Additional Information:
Experience: min. 10 years
Location: Hyderabad-India
Education: Ph.D, Cell Biology, Biotechnology, Biochemistry
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
Tracking Code: 98-679
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End Date: 4th July, 2013
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