Associate Director, Biologics

US Pharmacopeia
Posted

Post Expires

Type

Executive / senior industry position

Associate Director, Biologics

Full-Time/Regular

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.

Supervisory Responsibilities:

Basic Qualifications

  • 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.

Required Experience

Preferred Qualifications

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

Equal Opportunity/Affirmative Action Employer

USP is proud to be an equal opportunity/affirmative action employer. Employment selection and related decisions are made without regard to sex, gender identity, race, age, disability, religion, national origin, color, veteran status or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please send an e-mail to humanresources@usp.org or call (301) 230-3257 and/or 711 for TTD/TTY service.

3rd Party Recruitment Agencies

USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Any unsolicited resumes sent to USP, including unsolicited resumes sent to a USP address, or email address, directly to USP employees, or to USP's resume database will be considered USP property. USP will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. USP considers candidates for whom an agency has submitted an unsolicited resume to have been referred by the agency free of any charges or fees.

More Information

Posted

Post Expires

Type

Executive / senior industry position

Hyderabad%2C%20India

Hyderabad , India