Scientist IV, Analytical Research & Development

BioSpace; Indiana; Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

USP is seeking a Scientist IV to support process development and scale-up of APIs and related materials in analytical chemistry. The role involves method development, in-process testing, and routine and non-routine analytical work within a GLP-compliant lab.

You will collaborate with scientists and USP personnel to drive project outcomes, participate in ISO-9001 activities, and contribute to public health standards and quality assurance initiatives.

Formación

• Hands-on experience in analytical research and development in pharma.
• Experience with analytical method development and validation.
• Familiarity with quality systems (GLP, ISO-9001) and cGXP.
• Strong technical writing and data interpretation skills.
• Ability to work in cross-functional teams and manage projects.

Responsabilidades

• Support reaction monitoring, scale-up and final analysis per procedures.
• Plan, execute, and complete projects per specifications, timelines and budget.
• Prepare and review SOPs, protocols and reports.
• Coordinate with external vendors and internal departments to meet requirements.
• Maintain equipment maintenance and calibrations; IQ/OQ/PQ of new instruments.
• Assist ISO-9001 certification/recertification activities and audits.
• Maintain GLP and safety procedures in the lab.
• Contribute to lab management activities and cross-functional collaboration.
• Promote Diversity, Equity, Inclusion & Belonging in the team.

Conocimientos

Technical writing

Verbal communication

Team collaboration

Project management

Educación

Bachelor-level degree in Analytical/Organic Chemistry or M.Pharm

PhD in Analytical Chemistry or related field

Herramientas

HPLC

GC

LC-MS

GC-MS

FTIR

UV-Visible

Wet chemistry

Descripción del empleo

Description

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 minds—regardless of background—to 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, USP’s 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.
• 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:

• Sc. in 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.
• 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

Desired preferences are to showcase any additional preferred levels of expertise to perform the role. Reminder: any items listed in this section are not requirements nor disqualifies for candidate consideration.

• Understanding of process analytical technology, chemometrics, and knowledge of in-line, online, at line process analytical tools (e.g., IR, Raman, HPLC)
• 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.
• 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.
• Base Salary Range: USD $[XX,XXX – XX,XXXX] annually.
• Target Annual Bonus: % Varies based on level of role.
• Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons.

Job Category: Chemistry & Scientific Standards

Job Type: Full-Time