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 – Vaccine
Job Description:
Function of the Position:
This is a supervisory management position in which the incumbent is responsible for managing the Vaccine Group of USP-India’s Biologics and Biotechnology Division. Oversees daily operation of the laboratory, lead and manage Vaccine Group to promote good quality prophylactic and Therapeutic products globally.
Roles and Responsibilities:
• Responsible to ensure that lab adheres to USP’s mission, goals, and objectives.
• Directs and conducts the development of vaccines tests and standards (traditional, recombinant, polysaccharide, multivalent) relevant for public use.
• Develop annual budgets, projects resources and capital requirements for vaccine group.
• Assess and provide resources for the maintenance of Cell Biology/Bioassay Group while directing the development of alternate potency assays wherever possible.
• Assists VP in planning, implementing and evaluating laboratory procedures/systems.
• Assist in the USP-MC activities including collaborative RS development works internationally
• Coordinate different collaborative projects, training projects in the area of Vaccines both at National and International level, including organizations such as CDL, Kasauli. Facilitate information sharing from such national and international laboratories and vaccine manufacturers.
• Technically reviews and edits all output from Vaccine Group, including experimental results and reports.
• Supervises 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.
• Pro-actively attends scientific seminars as appropriate to bring in the latest developments in vaccines.
• 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 duties as assigned.
Candidate profile:
Minimum requirements:
Ph.D. in Microbiology, Biotechnology, Biochemistry or related field with not less than 10 years of relevant experience, including demonstrated laboratory experience.
Knowledge, Skills & Abilities:
A comprehensive understanding of the science involved in the development of Biopharmaceutical standards and reference materials is required. Broad experience in the quality control of traditional, recombinant, polysaccharide and multivalent vaccines, along with experience in method qualification and validation are required. 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.
Additional Information:
Experience: min. 10 years
Location: Hyderabad / secunderabad -India
Education: M.Pharm, M.Sc
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: QA
Job ID: 10899
End Date: 30th june,2012
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