Nithin Singam

Analytical Scientist | Biologics

Role: Senior Scientist - i at US Pharmacopeia
Location: Hyderabad, IN
LinkedIn followers: 500 followers

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Experience

Senior Scientist - i
US Pharmacopeia
Jul 2023 — Present · Hyderabad, IN
Planning and execution of Compendial and Collaborative projects besides contributing in the new initiatives viz, proof of concept studies in Biologics to support legacy and New Reference standards development.• Coordinate and manage Method development and regular analysis, using HPLC/UPLC (with Empower), SoloVPE, ELISA, SDS-PAGE, CE (Sciex PA-800 Plus and MauriceFlex), LCMS (Orbitrap Exploris 240) etc. for assigned products.• Actively participating in new Reference Standard development to evaluate the feasibility of LC and MS based methods by involving in technical discussions and supporting the method development activities. • Proficient in data analysis and review in NuGenesis ELN (LMS) and SDMS.• Successfully coordinated with US counterparts in Method transfer activities to establish the Multi-Attribute Method (MAM) capability in India lab.• Assisted in planning and execution of ‘Conventional vs Multi-Attribute Method’ to support the PoC studies funded by FDA under BsUFA Involving in Evaluation of CapEx and Preparation and review of URS and Justifications for new CapEx. • Preparation and review of Reports, Study protocols, to ensure compliance to USP’s Quality Management System and contribute in ISO 9001 and ISO 17025 audits.• Collaborate with cross-functional/global teams to support and align with Global Biologics objectives.• Supported the Instrument qualifications, Trainings and Annual PQ in collaboration with external vendors• Assist in laboratory management; maintenance of equipment and instruments, • Inventory management of consumables/critical reagents as per project requirements.

Skills

Sds-Page
Fermentation
Downstream Processing
Sop
Protein Purification
Column Chromatography
Bioprocessing
Purification
Hplc
Agarose Gel Electrophoresis
Immunology
Biotechnology
Glp
Tff
Technology Transfer
Elisa
Microbiology
Centrifugation
Chromatography
Western Blotting
Gel Electrophoresis
Validation
Biopharmaceuticals
Life Sciences
Fluorescence
Lc-Ms
Spectrophotometry

Contact information

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Current company

US Pharmacopeia

Pharmaceutical Manufacturing · 1.7K employees · Founded 1820 · Rockville, Maryland, United States

US Pharmacopeia (USP) is an independent, scientific nonprofit organization that has focused on building trust in the supply of safe, quality medicines since 1820. We are a public health organization that uses rigorous science and public quality standards setting to protect patient safety and improve global health. We are committed to building public trust and confidence in drug therapies to enable people to live longer and healthier, and also work to building trust in dietary supplements and food ingredients. Currently, we are working to strengthen the global supply chain so that the medicines people rely on are available when needed and work as expected. Our Volunteers USP standards are in a continuous process of review and revision based upon new evidence, emerging public health concerns, and public requests for revision. Input from our volunteers, through our Council of Experts and Expert Committees and Panels, is crucial for maintaining our standards and preserving public trust. Our Governing Bodies The USP Convention helps guide our areas of impact – nearly 500 Member Organizations from around the world contribute valuable perspectives, experiences, and expertise from across healthcare and science. In addition to collaborating on critical healthcare and science matters, every five years, Convention Members adopt USP Resolutions and elect USP’s Board of Trustees and the Council of Experts who lead USP’s standards-setting Expert Committees. Visit www.usp.org to learn more.

usp.org

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Experience

Senior Scientist - i

Skills

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