The U.S. Pharmacopeial Convention (USP) Associate Director, Biologics in Hyderabad, India
Associate Director, Biologics
The U.S. Pharmacopeial Convention (USP) is a scientific non-profit 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.
USP promotes Diversity & Inclusion at Workplace and encourages Equal Employment Opportunity and Affirmative Action
Summary of the Position
This is a supervisory management position in which the incumbent applies scientific knowledge and laboratory experience to lead and manage the Bioanalytical, Bioassay and Microbiology functions of India Biologics Laboratory. Directs and oversees daily operations of the laboratory and ensures implementation of good laboratory and documentation practices and compliance to USP’s Quality Management Systems. Collaborates cross-functionally and with global stakeholders for efficient delivery of projects and programs aligning to USP’s vision and mission. Leads and manages laboratory work towards new initiatives and programs of Global Biologics.
Roles and Responsibilities
Responsible to ensure that lab adheres to USP’s mission, goals and objectives and complies with USP’s guidelines and Quality Management System.
Lead, manage and perform supervisory role to ensure delivery of projects towards development of Reference Standards, Documentary Standards, new initiatives in Biologics, outreach and USP’s programs and services.
Direct, manage and mentor staff as assigned. Perform supervisory role such as goal setting, performance review, staff development and career counseling
Work with leadership team to develop and implement strategies and plans to advocate USP biologics standards
Collaborate with Global Biologics on new initiatives, process improvements and other organizational goals
Provide performance management updates and propose annual budgets, projects and staff resources for India-Biologics
Review project reports, SOPs and other documents and contribute in ISO 9001 and ISO 17025 audits.
Performs other duties as assigned.
Collaborate with USP cross-functional and global teams, such QA as appropriate.
Assists in the development and implementation of safety projects impacting BBL Lab personnel and the improvement of lab operation process to ensure quality and efficiency
Demonstrates a strong desire to continue learning and grow personal capability.
Yes, 3 Managers
Ph.D. in Biological Sciences or any other related stream with minimum of 15 years of work experience (post Ph.D.) in R&D/ARD/QC departments of Biopharmaceutical industry, including laboratory experience in compendial procedures. Strong managerial track record in directing and leading a team of Scientists is essential. Deep domain knowledge and experience in the characterization for biological products class specifically therapeutic proteins is essential.
The candidate should be well-versed on quality management system and understanding of Compendial requirements and has had a track record of delivering on the same.
The candidate should have minimum of 10 years of people/team management experience and excellent collaboration skills to interact and work with global teams.
Ph.D. in Molecular and Cell Biology/Biochemistry/Microbiology/Bioanalytical or any related stream with deep domain knowledge and strong practical skills working with Biologics product class. A comprehensive understanding of the science involved in the development of biopharmaceutical standards and reference materials is required. Deep Knowledge and experience in analytical R&D and molecular characterization of Biologics along with implementation of QMS is essential. Proven track record in leading and managing team of scientists besides excellent collaborative, interpersonal and coordination skills is essential. Excellent technical writing and verbal communication and presentation skills are required. A proven leadership and staff management skill is a must.
Job Category Laboratories