The U.S. Pharmacopeial Convention (USP) Associate Director, Biologics in Hyderabad, India
Associate Director, Biologics
This is a supervisory management position in which the incumbent applies scientific knowledge and practical laboratory experience to manage the Microbiology and Bioassay functions of India Biologics Lab and is also responsible for executing projects on method development and validations, development of new technologies, characterization of biologics, collaborative testing of biologics reference standards, trainings, collaboration with Rockville lab and other department activities. Oversees daily operations of the laboratory, collaborates cross functionally and with global biologics labs and manages the Microbiology and Bioassay India staff.
Roles and Responsibilities:
Responsible to ensure that lab adheres to USP’s mission, goals and objectives. and complies with USP’s guidelines and other requirements.
Perform technical Supervision and training of staff in the lab to build capabilities for core compendial work.
Build capabilities to conduct classroom and laboratory based PE (Pharmacopeial Education) programs in Microbiology and Bioassay. Contribute in content development and actively engage in new USP educational training programs.
Review data and project reports and release reports.
Responsible for review and implementation of SOPs, Protocols, Control Documents etc.
Direct and supervise collaborative project and Verification project works in bioassay and microbial testing.
Assist in the USP-NF activities for General Chapters, Monographs and Reference Standard development.
Adheres to USP’s Quality Management System and participates and contributes in ISO 9001 and ISO 17025 audits.
Perform managerial duties such as performance reviews, objective setting, staff development and career counseling.
Propose annual budgets, projects resources, capital and personnel needs for Bioassay and Microbiology functions.
Work with management team to develop and implement strategies to advocate USP biologics standards in India
Participate in USP cross-functional and global teams as appropriate.
Assist Director, VP & Global head in the integration of global Biologics Labs.
Assist in the development and implementation of safety projects impacting BBL Lab personnel.
Demonstrate a strong desire to continue learning and grow personal capability.
Performs other duties as assigned.
Ph.D. in Biological Sciences or M.Sc. in Microbiology, Biochemistry, Biotechnology or any other related stream with minimum of 12 years of experience (post Ph.D.) or minimum of 15 years of experience (post M.Sc.) in Microbiology and Bioassay functions in Biopharmaceutical industry, including laboratory experience in Compendial methods. Knowledge and experience in physico-chemical characterization of biologics is desirable.
The candidate should have knowledge on quality management system and basic regulatory filing requirements. Management experience with a group of scientists and good communication skills with multiple disciplines are essential.
Candidate should have minimum of 6 years of managerial experience.
Demonstrates a deep domain knowledge and strong practical skills in the areas of microbiology and Bioassay.
Knowledge and experience in analytical R&D for physico-chemical characterization of Biologics is desirable.
Laboratory experience must include method development and validation.
Experience in coordination and facilitation of collaborative studies is 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.
A proven leadership and staff management skill is a must.
Hyderabad, Andhra Pradesh, India
Job Category Scientific