Scientist IV, Bioanalytical

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 hands-on non-supervisory individual contributor position in which the incumbent applies their knowledge and practical experience in execution of bioanalytical projects on collaborative testing of Reference Standards Analytical Reference Materials documentary standards and characterization of different biological products. Additionally the incumbent will also actively engage and contribute in verification international and national reference standard development programs as assigned.

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 Sceintist IV has the following responsibilities:

• Aligns with USPs mission goals and objectives and complies with USPs guidelines and other requirements.
• Demonstrates strong laboratory skills and hands-on expertise in Mass Spectrometry for mAbs and other proteins/peptides Capillary Electrophoresis HPLC/UPLC Ion Chromatography.
• Technical knowledge on SDS-PAGE Western blot IEF and various Biochemical Assays is an added advantage.
• Plans and executes Compendial and R&D projects besides contributing in the new initiatives viz. proof of concept studies in Biologics for product classes such as proteins enzymes vaccines monoclonal antibodies cell and gene therapy peptides antibiotics raw material and any other biological products as assigned.
• Ability to plan design execute and resolve technical issues within the scope.
• Evaluates and analyzes scientific reports applies personal experience academic training and technical insights to troubleshoot and solve problems in the laboratory within the scope.
• Performs administrative responsibilities mentors and trains team member/members as assigned.

• Actively engages in project coordination with cross-functional/global teams and aligns with Global Biologics objectives.

• Prepares and reviews project reports SOPs and other documents to ensure compliance to USPs Quality Management System and contribute in Internal audits ISO 9001 and ISO 17025 audits

• Assists and recommends improvements in laboratory/project management methods and processes.
• Performs other duties as assigned.

The Sceintist III has the following responsibilities

• Aligns with USPs mission goals and objectives and complies with USPs guidelines and other requirements.
• Demonstrates strong laboratory skills and hands-on expertise in Mass Spectrometry for mAbs and other proteins/peptides Capillary Electrophoresis HPLC/UPLC Ion Chromatography.
• Technical knowledge on SDS-PAGE Western blot IEF and various Biochemical Assays is an added advantage.
• Plans and executes Compendial and R&D projects besides contributing in the new initiatives viz. proof of concept studies in Biologics for product classes such as proteins enzymes vaccines monoclonal antibodies cell and gene therapy peptides antibiotics raw material and any other biological products as assigned.
• Ability to plan design execute and resolve technical issues within the scope.
• Evaluates and analyzes scientific reports applies personal experience academic training and technical insights to troubleshoot and solve problems in the laboratory within the scope.
• Performs administrative responsibilities mentors and trains team member/members as assigned.

• Actively engages in project coordination with cross-functional/global teams and aligns with Global Biologics objectives.

• Prepares and reviews project reports SOPs and other documents to ensure compliance to USPs Quality Management System and contribute in Internal audits ISO 9001 and ISO 17025 audits

• Assists and recommends improvements in laboratory/project management methods and processes.
• Performs other duties 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 following competencies and experience:

• MSc././. in relevant stream of Biological Sciences with 6-8 (Scientist III) or 8-10 (Scientist IV) years of industry experience working in Analytical R&D and/or QC department of Biopharmaceutical industry and has hands on experience in work recombinant therapeutic mAbs proteins peptides and /or CGT and Vaccines.
• The candidate should be well-versed with operation and troubleshooting of all instruments used in performing the above-mentioned analytical techniques and should have sound knowledge of QMS systems.

Additional Desired Preferences

• Previous experience working in biopharma cGLP/cGMP/QMS environment with practical experience in good documentation practices would be an advantage.
• The candidate should have strong competencies in technical writing communication and presentation skills.
• Good written and verbal communications skills

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.

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.