Scientist IV, Analytical Research & Development (Process Analytical Technology)

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 non-supervisory position to support process development and scale-up of Active Pharmaceutical Ingredient (API) and related materials. The successful applicant in this role will work on projects including Analytical Method Development and evaluation for in-process samples for synthetic chemistry. The successful candidate will also perform a variety of non-routine and routine analytical tests maintains safety & GLP environment in the lab including development/validation of methods stability studies and research projects in analytical chemistry. The successful applicant will direct troubleshoot and share insights on complex projects while drawing independent conclusions about the results and determining how to proceed with the project. They closely collaborate with other scientists and/or other USP personnel.

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 Scientist IV has the following responsibilities:

• Support reaction monitoring scale-up and final analysis of samples as per monograph /in-house procedures including method development/validation if required. Prepare development reports for Synthetic Support projects. Execute projects per the approved test protocols if assigned.
• In collaboration with the synthetics team evaluate implement and grow Process Analytical Technologies (PAT) capabilities and expertise. This includes evaluation of process monitoring understanding and control via in line online and at line techniques. Serve as technical expert and champion for PAT and/or process model building.
• Plan execute and complete the projects as per specifications timelines and budget.
• Responsible for preparation and review of SOPs protocols reports etc.
• Ensure project requirements by coordinating with external vendors and all internal relevant departments.
• Responsible for ensuring the required maintenance and calibrations of the equipment
• Responsible for preparing executing and completing IQ/OQ/PQ of new instruments as assigned
• Preparation and planning for ISO-9001 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 in a timely manner.
• Maintain GLP & implement safety procedures while working in Lab.
• Work on any other assigned tasks/ lab management activities.
• Conversant with lab safety norms and strictly follow them.
• Collaborate within the team and cross functional teams
• Learn and practice Diversity Equity Inclusion & Belonging culture

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:

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:

• Analytical Chemistry / Organic Chemistry/M. Pharm having 8-10 years of experience in Analytical Research and Development or Ph.D. with 4-7 years of experience in Analytical Research and Development.
• Must have hands on experience in working with chemical methods and handling instruments like HPLC GC LC-MS GC-MS FTIR UV-Visible wet chemistry etc.
• Understanding of process analytical technology chemometrics and knowledge of in-line online at line process analytical tools (e.g. IR Raman HPLC)
• Experience in analytical testing and development with focus on process analytical chemistry and to understand monitor and control chemical processes/reactions.
• A comprehensive understanding of the science involved in the development of synthetic organic molecules and analytical chemistry.
• Ability to perform analytical method developments and method validations as and when required.
• Excellent technical writing and verbal communication skills
• Good interpersonal skills and proven ability to function in a team-oriented environment are necessary.

We especially welcome applications from those who hold historically marginalized and/or underrepresented identities. This job description provides a portrait of an ideal candidate. Candidates who possess many though perhaps not all qualifications are encouraged to apply.

Additional Desired Preferences

• Hands on experience with PAT instruments techniques and models such as in line at line or online IR Raman HPLC NMR etc.
• Experience with a wide variety of software and laboratory information systems including chemometric modeling software
• Working knowledge of API manufacturing and product testing (e.g. ICH guidelines USP general chapters and monographs)
• Expertise with USP compendial methods and requirements (e.g. monographs and general chapter) and ICH quality guidelines
• Pharmaceutical laboratory experience method development and method implementation in manufacturing environments and/or continuous manufacturing experience.
• Strong project management skills with ability to be effective both independently and in collaborative teams
• Skilled in evaluation and interpretation of data; Ability to multi-task.
• Skilled in anticipating troubleshooting and solving technical problems.
• Takes personal responsibility to ensure work is delivered on time and is of the highest quality.

Supervisory Responsibilities

NA

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 specificwritten agreement with USP.