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 laboratory experience to manage India Biologics Lab delivering projects on quality testing and development of Reference Standards for Biologics product classes such as therapeutic proteins, monoclonal antibodies, peptides, glycosaminoglycans and blood products following USP’s standard setting processes. Additional responsibility is to deliver USP training courses on Bioanalytical/Bioassay and contribute in development of course content.
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.
Review data, project reports, draft and review SOPs and other documents and ensure compliance to USP’s Quality Management System and contribute in ISO 9001 and ISO 17025 audits.
Perform managerial and technical supervision of Bioanalytical and Bioassay functions besides training of staff in the lab to build capabilities for core compendial work.
Deliver USP Training Courses and contribute in content development in coordination with Global team.
Perform managerial duties such as management updates, performance reviews, objective setting, staff development and career counseling and lead new initiatives.
Performs other duties as assigned.
Ph.D. in Biological Sciences or any other related stream with minimum of 10 years of work experience (post Ph.D.) in Bioanalytical and Bioassay function of a Biopharmaceutical industry, including laboratory experience in Compendial procedures.
Technical and managerial experience in design, development and validation of Bioanalytical methods and Bioassays for Biologics product class specifically therapeutic proteins and mAbs is essential.
Deep domain knowledge and practical experience in molecular characterization of biologics is preferred.
The candidate should have knowledge on quality management system and understanding of Compendial requirements.
The candidate should have excellent presentation and communication skills and prior experience in delivering training courses will be preferred.
The candidate should have minimum of 5 years of people management experience and excellent collaborative skills to interact and work with global teams
Ph.D. in Molecular and Cell Biology/Biochemistry with deep domain knowledge and strong practical skills in Bioanalytical and Bioassay areas. Knowledge and experience in analytical R&D and molecular characterization of Biologics is preferred. Laboratory experience must include method development and validation and sound understanding of compendial procedures. Experience in coordination and facilitation of collaborative studies is desirable. Excellent technical writing and verbal communication and presentation 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