Officer - R&D - API Manufacturing India International Technical Recruiters

1.0 - 5.0 years

2 - 4 Lacs

vapi

Work from Office

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

Posted 14 hours ago

Apply

ARD Chemist/ Scientist Macsen Laboratories

3.0 - 7.0 years

0 Lacs

udaipur, rajasthan

On-site

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 instruments, maintaining proper records as per regulatory and internal quality standards, and supporting the preparation of SOPs, protocols, and technical reports. To excel in this role, you should possess a strong knowledge of HPLC, GC, and LC-MS techniques, have experience in method development and impurity profiling, be familiar with ICH guidelines and regulatory requirements, be proficient in analytical software like Empower/Chromeleon, and have good documentation and communication skills.,

Posted 1 month ago

Apply

Chemist/ Scientist Macsen Laboratories

3.0 - 7.0 years

0 Lacs

udaipur, rajasthan

On-site

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 all analytical instruments are maintained in optimal working condition through regular calibration and documentation. In addition, you will play a crucial role in maintaining proper records as per regulatory and internal quality standards, supporting the preparation of SOPs, protocols, and technical reports, and ensuring compliance with ICH guidelines and regulatory requirements. To excel in this role, you must possess a strong knowledge of HPLC, GC, and LC-MS techniques, along with experience in method development and impurity profiling. Familiarity with analytical software such as Empower/Chromeleon, good documentation, and communication skills are also essential for success in this position.,

Posted 1 month ago

Apply

Assistant Manager/Deputy Manager - Formulation Analytical - Peptides Eugia Pharma Specialities

5.0 - 9.0 years

7 - 11 Lacs

Hyderabad

Work from Office

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

Posted 1 month ago

Apply

Reqd Regulatory Affairs - Sr Officer/Exe- Pharma API Business Exemed

3.0 - 5.0 years

3 - 5 Lacs

Vadodara

Work from Office

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 (both Open and Closed Parts) for submission to national and international regulatory authorities. Ensure data integrity and compliance with ICH and other global regulatory guidelines . Regulatory Documentation & Submissions: Prepare, review, and submit CDSCO-specific checklists for New Drug Applications (ND) and SND (Subsequent New Drug) filings for APIs. Regulatory Compliance: Stay current with evolving regulations and guidelines issued by CDSCO, ICH, USFDA, EMA , and other global regulatory bodies. Assist in audits and regulatory inspections by preparing and presenting required documentation. Liaison with Regulatory Authorities: Coordinate with Local FDA & CDSCO Liaison concerned person and other regulatory authorities for smooth regulatory processes and communication. If interested please share updated resume on corporate.hr@exemedpharma.com

Posted 3 months ago

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.