Associate Director, Synthetics Lab - Military Veterans

Description

Who is USP?

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—an environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

Brief Job Overview

This is a managerial position in which the incumbent applies scientific expertise and laboratory experience for leading a team of scientists engaged in the synthesis of USP Reference Standard candidate materials, API Impurities and APIs on milligram to multigram scale. The key responsibilities of the position include delivery of synthesis projects, lab management, implementation of EHS guidelines and ensuring QMS compliance and team productivity. In addition to regular synthesis projects, the incumbent is also responsible for organizational initiatives and special tasks/projects as assigned and meeting the deliverables.

How will YOU create impact here at USP?

In this role at USP, you contribute to USP's public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.

The Associate Director has the following responsibilities:

• Leading a team of scientists working on synthesis of USP-Reference Standard candidates, API Impurities for PAI and CDL programs and APIs



• Design and development of efficient, safe, and cost-effective synthetic routes for the given target molecules.



• Provide technical guidance to the team in troubleshooting synthesis, scale up and purification issues.



• Accountable for the literature search and review related to projects using various scientific data base and ensure quality proposals.



• Preparation and review of project proposals and cost estimates



• Accountable for projects planning, execution, tracking the progress of the project and ensuring the delivery of quality materials within timelines.



• Coordinate with Analytical R&D, Procurement and Logistics, Lab Operations, EHS, HR and QA teams as needed.



• Ensuring RM procurement as per project requirement



• Ensuring QMS compliance in all project/ departmental related activities as applicable.



• Project allocation to scientists and resource management



• Review and sign-off of LNBs and verifying documentation of experiments conducted, and the observation made as per LNB guidelines.



• Handling QMS issues and supporting the team in initiating and closing the issues.



• Active involvement in preparation and facilitation of internal external (ISO) audits



• Ensure EHS compliance among the team and lab



• Responsible for preparation/review of SOPs, protocols, reports etc. as per the need



• Responsible for Lab management operations and ensure smooth functioning of the lab.



• Responsible for goal setting and performance review of team members



• Play active role in the development of flow chemistry capabilities at USP



• Contributing/leading organizational initiatives and proposing Research and Innovation projects having relevance to USP



• Support HR in talent acquisition process.



• Responsible for the preparation/review of scientific poster presentations and research publications.



• Contribute and ensure the productivity goals of the team and departmental objectives



• Support Director-Synthetics Lab in overall delivery of projects, lab operations and customer communication and departmental productivity.



• Develop Great People Management (GPM) competencies.



• Promote DEIB practices among the team and facilitate trainings.



• Work on staff development and skill enhancement.

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:

• PhD in synthetic organic chemistry from a reputed institute/ university with minimum 15 years of post-Ph.D work experience in Pharma R&D/CRO in the area of process chemistry / synthetic/ medicinal chemistry (or) Post-doctoral with minimum 12 years of industrial experience.



• Sound expertise in synthetic organic/ API process development and troubleshooting



• Track record of research publications in internationally reputed journals and patents



• Proven ability to lead team of scientists working towards organizational goals.



• Strong background on QMS/GLP knowledge and documentation procedure



• Experience in handling internal and external audits



• Experience in drafting and reviewing SOPs and guidelines



• Conversant with EHS practices and guidelines



• Strong theoretical background for predicting NMR spectra, structure elucidation, reaction feasibility, reactivity of organic molecules, and Elemental analysis etc.



• Good at drafting project reports and manuscripts for publications



• Excellent communication skills

Additional Desired Preferences

• Outstanding track record of research publications/patents with at least five first authored/ main authored publications in peer-reviewed journals of international repute.



• Hands on experience in the synthesis of small molecule APIs, API Impurities, peptide synthesis and contract research projects.



• Experience in pharmaceutical continuous manufacturing process and Flow Chemistry techniques.



• Should have worked directly within GMP facilities engaged in the manufacturing bulk active pharmaceutical ingredients (APIs)



• Should have exposure to GMP/GLP environment and documentation procedures.



• Exposure to working in regulated environment/ exposure to regulatory requirements



• Ability to handle multiple priorities in a fast-paced environment.



• Excellent communication and proficiency in English

Supervisory Responsibilities

Yes, 2-4 direct reports (Senior Scientist-II/Principal Scientist -Team Leads); Team size #8-12

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.

Note: 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

Job Category Chemistry & Scientific Standards

Job Type Full-Time