13 Impurity Profiling Jobs

You will be responsible for leading the characterization of peptides and small molecules using Liquid Chromatography and High-resolution mass spectrometry (LC-HRMS, LC-MS/MS) to determine structural elucidation and impurities profiling. As a Team Lead, you will manage a team focused on Peptide / Protein characterization through HRMS. Your duties will include method development, impurity profiling of Peptides/Proteins, and Impurities characterization using HRMS. Additionally, you will utilize spectroscopy (UV-Visible, Circular Dichroism, Spectrofluorometer), Capillary Electrophoresis, and analytical method development for characterization purposes. - Handling LC-HRMS for Characterization of P...

Role Overview: You will be responsible for developing, optimizing, and validating analytical methods using GC and GC-MS/MS for various sample matrices. Your role will involve performing routine and non-routine analysis of raw materials, intermediates, and finished products. You will interpret complex chromatographic data, ensuring accurate documentation and reporting. Additionally, you will maintain and calibrate GC and GC-MS/MS instruments to ensure compliance with regulatory standards. Troubleshooting instrument and method-related issues to ensure uninterrupted lab operations will also be a part of your responsibilities. You will be preparing SOPs, method validation protocols, and reports ...

1. Cost effective/cost competitive process development of APIs. Plan/design and conduct experiments. Impurity profiling of APIs and Synthesizing the potential impurities. Identification of improvement areas in process development. Resolving the technical/process related issues and trouble shooting plant related issues or investigation. Design and conduct experiments to identify the root cause for quality failures (or) loss of yield. Collaborating and Coordination with Plant R&D (MSAT) (Manufacturing Science & Technology) Skill- set: Strong organic chemistry knowledge. Strong analytical & interpretation skills. Good interpersonal & communication skills.

As an ARD Chemist / Scientist at the Udaipur location, you will be a key member of the ARD team, responsible for method development and validation, impurity profiling, and instrumental analysis to support Synthesis R&D and quality operations. - Developing and validating HPLC, GC, and LC-MS analytical methods for monitoring in-process reaction samples. - Developing HPLC methods suitable for Analytical Method Validation (AMV) and transfer to QC. - Performing impurity profiling of APIs and intermediates, identifying and characterizing impurities using advanced techniques like mass spectrometry. - Ensuring that all analytical instruments are maintained in optimal working condition through regula...

As an Analytical Specialist at our Contract Development and Manufacturing Organization (CDMO), you will play a crucial role in supporting analytical development and testing activities. Your expertise in analytical method development, validation, structural characterization, impurity profiling, and troubleshooting for drug substances and its intermediates will be essential in managing multiple client projects effectively. Additionally, you will serve as a mentor to junior team members and make informed decisions based on analytical data. Key Responsibilities: - Develop, optimize, validate, and transfer analytical methods in compliance with ICH and client-specific requirements. - Support the c...

As a Scientist / Senior Scientist / Principal Scientist in Peptide Synthesis at API R&D in Bangalore, your role will involve: - Conducting peptide synthesis using solid and solution phase strategies, both manually and with automated synthesizers - Performing C- and N-terminal modifications, peptide conjugations, and impurity profiling - Purifying peptides and impurities - Writing lab journals and preparing technical documents - Characterizing peptides analytically and spectroscopically Your qualifications should include: - Ph.D. / MSc./M.Pharm. in Chemistry - Experience in solid-phase and solution phase peptide synthesis - Knowledge of hybrid technologies and Molecular Hiving would be advant...

Role - Peptide Synthesis in API R&D Level - Scientist / Senior Scientist / Principal Scientist level Job Location - Based at Bangalore Technical Skills:- Peptide synthesis by solid as well as solution phase strategy by using manual and or automated synthesizers, cleavage isolation Solid-phase and solution phase peptide synthesis C- and N-terminal modifications, peptide conjugations Impurity profiling, synthesis, isolation Purification of peptides and impurities Writing lab journals, preparing technical documents Analytical and spectroscopic characterization of peptides Required Skills: Good solid-phase and solution phase peptide synthesis exp ; Hybrid technologies / Molecular Hiving expertis...

As an Analytical Chemist at our leading Contract Research Organization (CRO), you will have the opportunity to assist in conducting analytical testing of samples using instruments such as HPLC, GC, LC-MS/MS, and UV Spectrophotometer under supervision. You will play a crucial role in preparing reagents, solutions, and standards following Standard Operating Procedures (SOPs) with precision and attention to detail. Your responsibility will include accurately recording and maintaining raw data, logs, and reports in compliance with GLP/GMP standards. By ensuring proper documentation, you will play a pivotal role in meeting regulatory and internal audit requirements. You will provide essential sup...

Design & develop API/intermediate processes, optimize & validate methods, analyze data (HPLC, GC, NMR, IR, MS), impurity profiling, documentation, lab record management & equipment maintenance. Required Candidate profile 1 - 5 years of experience BSc./ MSc. in Chemistry

You will be joining our ARD team in Udaipur as an ARD Chemist / Scientist. Your main responsibilities will include method development and validation, impurity profiling, and instrumental analysis to assist our Synthesis R&D and quality operations. Your key responsibilities will include developing HPLC, GC, and LC-MS analytical methods for monitoring in-process reaction samples, validating HPLC methods suitable for AMV, performing impurity profiling of APIs and intermediates, identifying and characterizing impurities using advanced techniques like mass spectrometry, ensuring all analytical instruments are well-maintained, performing regular calibration and documentation of analytical instrume...

As an ARD Chemist / Scientist at our Udaipur location, you will be a key member of our ARD team, responsible for method development and validation, impurity profiling, and instrumental analysis to support our Synthesis R&D and quality operations. Your primary responsibilities will include developing and validating HPLC, GC, and LC-MS analytical methods for monitoring in-process reaction samples, as well as developing HPLC methods suitable for Analytical Method Validation (AMV) and transfer to QC. You will also be tasked with performing impurity profiling of APIs and intermediates, identifying and characterizing impurities using advanced techniques like mass spectrometry, and ensuring that al...

Job Description : Experience in operation and calibration of (HRMS/qTOF). Experience on Intact Mass Analysis, peptide Mapping, Impurity profiling, unknown impurity structure identification, sequencing of Peptides, biosimilars and small molecules. Independent Data analysis of characterization experiments. Experience in impurity profiling of GLP1 analog peptide API and formulation products. Preparation of summary reports, SOPs, Protocols and Reports Transportation & Canteen Facilities Available

Company Name: Oneiro Lifecare Pvt Ltd Designation: Regulatory Affairs - Sr Officer/Executive - API Location- Ekalbara Plant (Vadodara) Preferred candidate profile Experience: 3 to 5 Years (M.Pharm (Pharmaceutical Chemistry)/ M.Sc. (Chemistry)/ B.Pharm) JOB PROFILE Interdepartmental Coordination: Liaise with cross-functional teams (R&D, QC, QA, Manufacturing, etc.) to gather, review, and consolidate technical information required for regulatory submissions. API Chemistry & Characterization: Provide expert input on molecular chemistry , including impurity profiling , characterization , and Nitrosamine impurity assessment . DMF (Drug Master File) Management: Prepare, maintain, and update DMFs (...