Senior Manager, Reference Standards Laboratory

At USP we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship professional development and leadership opportunities. Our partnerships standards and research reflect our belief that ensuring broad participation in scientific leadership results in stronger more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair merit-based selection processes that enable the best scientific mindsregardless of backgroundto contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

Brief Job Overview

This is a supervisory position responsible for managing the collaborative testing and stability activities. The incumbent in this role will be responsible for managing 02 teams in one of the labs. Collaborative testing involves the qualification of reference standards by prioritizing them as per their tier categorization and the timely delivery of quality reports to RSE Rockville by maintaining the GLP environment to support the organizations mission of making reference standards available to stakeholders. Stability testing is about conducting the shipping studies on reference standards to study the impact of humidity / temperature.

The incumbent needs to develop and work on a succession plan by identifying grooming and encouraging subordinates to take on additional responsibilities. Participate in strategic initiatives such as DEIB and others as appropriate to improve morale culture and productivity.

How will YOU create impact here at USP

As part of our mission to advance scientific rigor and public health standards you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity regulatory excellence and evidence-based decision-making to ensure health systems worldwide can rely on strong tested and globally relevant quality standards.

Additionally USPs People and Culture division in partnership with the Equity Office invests in leadership and workforce development to equip all employees with the skills to create high-performing inclusive teams. This includes training in equitable management practices and tools to promote engaged collaborative and results-driven work environments.

The Senior Manager has the following responsibilities:

• Initial review verification and approve the project related Test protocols and Test kits received from RSE/CSU departments in USP-Rockville and any other supporting work from other departments on a needy basis.
• Responsible for planning and coordination of projects in designated lab with collaborative testing and stability teams.
• Overall responsible for stability program by drafting and reviewing the test protocols compilation of reports preparing summary reports and responding to QA and stakeholders comments.
• Providing hands on training to the new joiners and existing reporting staff whenever required.
• Ensuring the implementation of GLP safety systems in the labs.
• Ensure adequate sample flow as per lab capacity by providing the inputs for sample clearance as well coordinating with Rockville.
• Ensure procurement of lab chemicals columns required for testing of the projects and proper allocation of instruments and resources for timely completion of projects.
• Communicating with RSE Rockville regarding the project issues and maintaining good relationships.
• Coordinate with project management team at Rockville to understand the priorities and plan the project accordingly.
• Preparation and planning for ISO-9001 & ISO- 17025 certification/recertification by participating actively verification of protocols and related documents and take an active role in the internal as well as external QA audits and address the audit issues on a timely manner.
• Taking up any other additional responsibilities assigned by supervisor on a proactive basis and allotting additional responsibilities to the reporting staff in consultation with the supervisor.
• Review and approve the sample report of project in the absence of technical reviewer.
• Supporting Verification PQM and other departmental teams in terms of project review and approval whenever needed.
• Demonstrate high productivity comparable to that of the other USP laboratory staff of the same level performing similar tasks.
• Organize the professional development seminars courses internal and external trainings for associates that will enhance the technical competencies to perform the testing.

Who is USP Looking For

The successful candidate will have a demonstrated understanding of our mission commitment to excellence through inclusive and equitable behaviors and practices ability to quickly build credibility with stakeholders along with the following competencies and experience:

Minimum of 5 years project lead and/or scientific reviewer experience required. Previous supervisory/mentoring experience with the ability to demonstrate superior leadership through interaction and communication urgency planning and technical ability. The candidate must have strong analytical chemistry knowledge with the ability to review analyze interpret and report effectively on data from a variety of analytical instrumental tests (e.g. HPLC GC IC LCMS Wet analytical techniques spectroscopic techniques Thermal analysis IC ICP etc.). Well-developed organizational and interpersonal skills. Able to establish and nurture relationships with individuals of varying backgrounds cultures and learning styles.

• Ph.D. in Chemistry or Masters degree in chemistry / Pharmacy.

Experience:

• 12 to 15 years with relevant laboratory experience for Ph.D. candidates.
• 15 to 20 years with relevant laboratory experience for Masters degree candidates.
• Proven track record of consistently delivering projects on time and with high quality for APIs.
• Expert in chromatographic analysis particularly in HPLC and GC.
• Proficient in other related analytical instrumentation such as Titration IR KF UV Thermal analysis Elemental analysis etc.
• Must possess excellent presentation and communication skills (both written and verbal).
• Expert in Empower software with knowledge on Audit trails and Custom fields.
• Must possess good technical and analytical skills to independently resolve or troubleshoot issues.
• Should be able to rapidly assemble the appropriate expertise to identify define and solve technical issues.
• Must possess the skill to increase the knowledge abilities and contributions of staff.
• Should have a strong understanding of GLP regulations and exposure to external regulatory audits.
• Takes personal responsibility for delivery of projects to customers.
• Ability to embrace and lead change. Extremely adaptable.

Additional Desired Preferences

• Having knowledge of Lab Management System and Electronic Laboratory Notebook ERP QR coding system is an added advantage.
• Hands-on experience in handling advanced instrument like ICP-OES/MS IC LC-MS and GC-MS is an added advantage.
• Understanding monograph procedures and participating in compendial methods for reference materials (USP FCC NF etc.).
• Prior experience in a high-volume pharmaceutical manufacturing QC laboratory or Analytical R&D or a contract pharmaceutical analytical laboratory testing organization is a plus.
• Awareness of ISO/IEC 17025 is desirable.

Supervisory Responsibilities

Yes

Incumbent is responsible for the leadership of up to 07 direct reports i.e. team leads /05 indirect reports (scientists).

Benefits

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings you can have peace of mind that your personal and financial well-being is protected.

Required Experience:

Senior Manager