Scientist IV, Documentary Standards

BioSpace; Indiana; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Company-paid time off

Healthcare options

Retirement savings

Job summary

USP in Indiana seeks a Scientist IV (Reviewer) to provide technical and quality reviews of documents for biological products including peptides, vaccines, and complex biologics. The role supports the Reference Standards program and stability testing, ensuring accuracy, clarity, and compliance across documentation.

The incumbent will work with cross-functional teams, develop SOPs, and review analytical data to confirm RS suitability, contributing to continuous process improvements while

Qualifications

• Ph.D. in Biochemistry/Biological Science/Pharmaceutical Science with 3–5 years of commensurate industrial experience, or Master's with 8–10 years of commensurate industrial experience.

Responsibilities

• Performs technical and quality reviews of documents to ensure a high level of document quality and compliance before QA review.
• Manages and tracks efforts for continuous process improvements.
• Develops and reviews SOPs, Operation Manuals, and training documents.
• Assists in investigations of quality related issues including root cause analysis and action implementation tracking.
• Collaborates with internal stakeholders to develop new and innovative standards for analytical analysis of biological products.
• Communicates with cross functional USP departments regarding assigned projects.
• Supports RS Stability program operations and RS catalog inventory.
• Reviews RS testing history and drafts CSU test protocols for labs.

Skills

Technical writing

Analytical reasoning

Oral communication

Team collaboration

Education

Ph.D. in Biochemistry/Biological Science/Pharmaceutical Science

Master’s degree in Biochemistry/Biological Science/Pharmaceutical Science

Tools

UPLC/HPLC

LC-MS

CD

FTIR

DSC

SEC‑MALS

CE‑SDS

ELISA

SPR

ddPCR/qPCR

Job 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 hands‑on, non‑supervisory scientific position in the Global Biologics. The incumbent is responsible for providing support for the development of USP documentary standards and reference standards for biological products such as Peptides, Oligonucleotides, Proteins, Carbohydrates, Complex Biologics, Vaccines, Antibiotics, and Advanced Therapies etc. The incumbent will provide quality and technical review of scientific documents for accuracy, clarity and compliance, manage and track reference standard stability program and organize efforts for continuous process improvements. The incumbent will also focus on supporting the reference standard suitability program, including preparing and reviewing CSU testing protocols, providing technical assistance to testing labs, reviewing analytical data and preparing summary reports for confirming the continued suitability of USP Reference Standards (RS). The incumbent needs to be excellent team player with good collaboration/liaising skills to complete assigned projects in time‑bound manner.

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 (Reviewer) Has The Following Responsibilities

Roles and Responsibilities

• Performs technical and quality reviews of documents to ensure a high level of document quality and compliance before QA review
• Manages and tracks efforts for continuous process improvements.
• Develops and reviews SOP’s, Operation Manuals, and training documents.
• Assists in investigations of quality related issues resulting from customer complaints to include root cause analysis, corrective action identification, action planning, and implementation monitoring.
• Works with internal stakeholders to develop new and innovative standards for analytical analysis of biological products.
• Communicates and maintains working relationships with cross functional USP departments regarding assigned projects
• Supports day‑to‑day operations of the RS Stability (CSU) program covering the USP Biologics RS catalog inventory.
• Reviews RS testing history and drafts test protocols for CSU studies and submits to labs based on designated testing requirements and schedules.
• Liaisons and Assists laboratories to ensure CSU testing is completed as per protocol and in timely manner.
• Reviews laboratory reports, evaluates results and compares previous data and RS attributes to assess and conclude on RS suitability for use.
• Compiles, assess current and historical stability testing data and prepare stability trend reports in a time‑bound manner.
• Support the maintenance and updating various databases documenting laboratory data and program determinations on suitability and Stability interval updates.
• Filing and closure of QMS elements as per QMS system when required and supports the RS Laboratory, Supporting Quality Assurance and Reference Standard Evaluation in the investigation of unexpected stability testing results
• Works collaboratively with various USP departments as needed on test planning, data impact assessments and appropriate determination of next steps.
• Prepare, present and discuss regular work updates with Team Lead and other team members

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

Scientist IV (Reviewer)

• Ph.D. degree in Biochemistry/Biological Science/Pharmaceutical Science, or a related field with a minimum of 3 to 5 years of commensurate industrial experience, or Master’s degree in Biochemistry/Biological Science/Pharmaceutical Science or a related field with 8 to10 years of commensurate industrial experience.

Preferred Qualifications

• Demonstrated experience in Technical review of analytical documents in Quality Assurance.
• Hands‑on experience with state‑of‑the -art analytical techniques for the characterization of recombinant therapeutic proteins, peptides, gene therapy, vaccines and carbohydrates, such as UPLC/HPLC, LC‑MS, CD, Fluorescence spectroscopy, FTIR, DSC, SEC‑MALS, CE‑SDS (Reducing and Non‑reducing), icIEF, ELISA, SPR, ddPCR/qPCR etc.
• Strong ability to evaluate and compile analytical testing data, ability to write technical reports related to material characterization, references standard evaluations, and method development.
• Demonstrated experience in analytical method development, method qualification/validation and characterization of biological products and impurities using a variety of physicochemical techniques and biological assays.
• Excellent technical writing, presentation and oral communication skills are required.
• Must be excellent team player and able to work amicably and communicate effectively with both internal and external stakeholders.

Additional Desired Preferences

• Knowledge of USP products and services is highly desirable.
• Operates collaboratively at all levels of the organization in a highly technical environment.
• Must be able to work in a fast‑paced environment and respond to shifting priorities.
• Well‑developed interpersonal, negotiation, conflict‑resolution and listening skills.
• Must possess the ability to multi‑task and to work effectively with a team.
• Takes ownership and personal responsibility to ensure work is delivered on time and is of the highest possible quality.
• Experience working in the compendial, pharmaceutical and/or biotechnology industry strongly preferred.

Supervisory Responsibilities

None, this is an individual contributor role.

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.

Job Category Chemistry & Scientific Standards

Job Type Full-Time