Senior Scientist I, Synthetics Laboratory (Peptides and Small Molecules)

Who is USP

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds leading health and science experts to develop rigorous quality standards for medicines dietary supplements and food ingredients. At USP we believe that scientific excellence is driven by a commitment to fairness integrity and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1300 professionals across twenty global locations working to strengthen the supply of safe high-quality medicines worldwide.

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

The role is engaged in the synthesis and delivery of USP Reference Standard candidate materials and API impurities (small molecules and peptides) through design and development of cost-effective synthetic routes. Candidate should carry literature search using scientific databases and work on planning and execution of synthesis of target molecules in mg to multigram/KG scale. Candidate should ensure the completion of assigned tasks as per timelines prepare project reports communicate with the team and update on the project progress. Candidate should be adherent to quality management systems (QMS) and lab safety practices

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 Senior Scientist I has the following responsibilities:

• Carry out literature search related to assigned projects using various scientific data base.
• Design synthetic routes for the target small molecules & peptides. Prepare project proposals with tentative cost estimates.
• Perform synthesis & isolation of pharmaceutical analytical impurities reference standards and degradation impurity standards.

• Execute small molecule synthesis and solid-phase and solution-phase peptide synthesis with a focus on quality.
• Perform peptide modification techniques including cyclization disulfide bridge formation stapling and derivatization.
• Support in characterization of peptides by utilizing advanced characterization techniques such as LCMS HPLC and NMR to ensure peptide quality and accuracy.
• Procure key raw materials and reagents required for the project
• Perform the reactions in small as well as large scale in the lab.
• Purification of compounds through various techniques such as crystallization column chromatography and advanced flash purification systems.
• Troubleshooting synthesis and purification issues independently

• Contributing effectively towards more challenging and complex projects through innovative methodologies
• Ensuring the availability of chemicals and equipment required for the projects and forward the purchase requisitions

• Interpretation of analytical data of synthesized compounds by IR NMR Mass Spectra Elemental analysis etc.
• Produce quality materials as per customer requirement
• Packaging of synthesized compounds
• Plan execute and complete the projects as per the timelines
• Document all experiments conducted as per QMS guidelines.
• Responsible for preparation of SOPs Protocols reports etc. as per the need
• Responsible for review the records and documents
• Responsible to ensure the calibrations of the equipment as per the schedule
• Periodic check of the assigned equipment to ensure its working condition
• Responsible for preparing executing and completing IQ/OQ/PQ of new instruments as assigned
• Work on any other assigned tasks/ lab management activities.
• Conversant with lab safety norms and strictly follow them.
• Communicate 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:

• M Sc (Organic Chemistry) from a reputed university with minimum 11-13 years of industrial experience in API Process R&D/CDMO/CRO (OR) Ph.D (Full Time) in Synthetic Organic Chemistry from a reputed group with 7-10 years of post doctoral and/or industrial research experience in API Process R&D/CDMO/CRO.
• Strong background in synthetic organic chemistry Interpretation of spectral data of compounds based on IR NMR HPLC Mass Elemental analysis and other analysis.
• Ability to independently search literature design optimize and develop synthetic processes for any given target molecules/APIs.

• Hands on experience in process development of diverse chemical class of Small Molecule APIs/ NCEs on lab scale and production.
• Experience in handling automated peptide synthesizers and purification processes is highly desirable.
• Proven ability for adoption of QMS and documentation procedure
• Adherence to lab safety guidelines
• Excellent troubleshooting skills in synthesis and purification of target compounds.
• Should possess good verbal and written communication skills.
• Should possess good organizational communication and interpersonal skills.

Additional Desired Preferences

• Extensive knowledge on wide range of organic reactions solid phase and complex peptide synthesis and hands on experience in handling various sensitive chemicals/reagents.
• Track record of patents/ publications in synthetic organic chemistry/ process development.
• Should have exposure to GMP/GLP environment and documentation procedures.
• Good practical documentation & presentation skills.
• Attention to detail stratregic thinking and problem-solving skills.
• Demonstrated ability to work both independently and as a member of a team with a passion for quality

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.

Required Experience:

Senior IC