Scientist III, Bioassay

The U.S. Pharmacopeial Convention (USP); Hyderabad; In loco; INR 1.200.000 - 2.000.000; Tempo pieno

Descrizione del lavoro

The U.S. Pharmacopeial Convention (USP) in India’s Biologics Laboratory seeks a hands-on Scientist II/III to perform bioassays, SPR-based characterization, and method development across biologic products.

The role emphasizes collaborative testing, standard development, and adherence to GLP/QMS standards. You will conduct relative potency assays, participate in method validation and transfer, and provide technical support to ensure quality standards for global health solutions.

Competenze

• MSc in Biochemistry or related Biological Science, with 4–8 years industrial experience.
• Experience developing and validating assays; knowledge of QMS.

Mansioni

• Demonstrates expertise in SPR technology, operation, maintenance, troubleshooting, and Biacore platforms for characterization and analytical studies.
• Performs and optimizes in vitro cell-based bioassays, including relative potency assays.
• Conduct method development, qualification, validation, and transfer studies per project requirements and guidelines.
• Plan and execute laboratory studies, analyze data, and document results in technical reports and presentations.
• Prepare and review protocols, reports, SOPs, and other scientific documentation.
• Support collaborative testing studies and development of Documentary Standards and Physical Reference Standards.
• Collaborate with cross-functional teams to address technical/process challenges.
• Stay current with advances in biologics and analytical technologies.
• Share knowledge and provide training to lab colleagues as needed.
• Support laboratory operations including equipment maintenance, inventory, organization, and documentation.
• Follow GLP, QMS requirements, and USP policies; participate in audits and continuous improvement.
• Attend scientific seminars, workshops, and conferences for professional development.
• Perform other duties as assigned.

Conoscenze

SPR technology

Relative potency assays

Cell-based bioassays

Data analysis

Formazione

MSc in Biochemistry

Strumenti

Biacore SPR

Descrizione del lavoro

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 role within USP-India's Biologics Laboratory. The scientist is expected to spend approximately 80–100% of their time performing laboratory-based activities, including bioassays, binding assays, viral assays, and molecular biology studies across a broad range of biologic product classes, such as recombinant proteins, monoclonal antibodies (mAbs), vaccines, cell and gene therapy (CGT) products, and viral vectors.

The scientist will be responsible for the hands‑on execution of scientific projects, including collaborative testing of reference standards, characterization of biological products, and the development, qualification, validation, and transfer of analytical methods supporting the establishment of Documentary Standards and Physical Reference Standards. The role also includes providing technical and operational support for activities within the India Biologics Laboratory, contributing to the advancement of standards development and scientific excellence.

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 II or III has the following responsibilities:

• Demonstrates expertise in Surface Plasmon Resonance (SPR) technology, including operation, maintenance, troubleshooting, and application of Biacore platforms for characterization and analytical studies.
• Performs and optimizes in vitro cell‑based bioassays, including relative potency assays, using established cell lines and primary cells.
• Conduct method development, qualification, validation, and transfer studies in accordance with project requirements and applicable guidelines.
• Independently plan and execute laboratory studies, analyze experimental data, and document results in technical reports and presentations.
• Prepare and review protocols, reports, standard operating procedures (SOPs), and other scientific documentation.
• Support collaborative testing studies, biological product characterization activities, and the development of Documentary Standards and Physical Reference Standards.
• Collaborate effectively with cross‑functional teams to address technical and process‑related challenges.
• Stay current with advances in biologics, analytical technologies, and relevant scientific literature.
• Share technical knowledge and provide training to laboratory colleagues, as needed.
• Support laboratory operations, including equipment maintenance, inventory management, laboratory organization, and documentation activities.
• Follow Good Laboratory Practices (GLP), Quality Management System (QMS) requirements, and USP policies and procedures.
• Participate in internal and external audits and support continuous improvement initiatives.
• Attend scientific seminars, workshops, and conferences to enhance technical knowledge and professional development.
• Perform other duties and responsibilities as assigned.

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 below competencies and experience

Note:

As part of the recruitment process, USP's Global Talent Acquisition team may contact candidates through a variety of communication channels, including Microsoft Teams, telephone, email, and WhatsApp (voice calls and text messages). These communications may be used to schedule interviews, provide updates on application status, discuss career opportunities, and answer questions about employment with USP.

To help ensure timely communication, candidates are encouraged to keep their contact information current and to engage only with individuals who clearly identify themselves as authorized USP representatives. USP will never request payment, banking details, or other financial information as part of the hiring process.

• MSc. in Biochemistry, or related Biological Science field with 6-8 (SIII) or 4-6 (SII) years of Industrial experience in bio pharmaceutical product development and quality testing, expertise in SPR, and relative potency assays. Able to analyze and interpret data using appropriate statistical software/methods and calculation for relative potency determination.
• An equivalent combination of education and experience may be substituted. Laboratory experience must include expertise developing and validating assays, and QMS knowledge and experience.

Additional Desired Preferences

Desired preferences include highlighting any additional preferred levels of expertise for the role—reminder: items listed here are not requirements and do not disqualify a candidate from consideration.

• Working experience in the biotechnology/biopharmaceutical industry strongly preferred.
• Demonstrated research, technical, and analytical skills, as well as the ability to take highly technical scientific information and make recommendations.
• Ability to learn new technologies and strong computer, scientific, and organizational skills.
• Good written and verbal communication skills, time management skills as well as interpersonal skills.
• Results driven with demonstrated successful outcomes.
• Individual must possess the ability to handle multiple priorities in fast‑paced environment.
• Knowledge/participation of reference standards development related to bio pharmaceutical products/industry.
• Experience with reference materials development is a plus.

Supervisory Responsibilities

None, this is an individual contributor role.

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 written agreement with USP.