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3.0 - 7.0 years
0 Lacs
haryana
On-site
As an Executive/Senior Executive in the R&D Quality-CMC QA department at Gurugram location, your role involves the following responsibilities: - Review various R&D documents including stability data, analytical reports, method qualification reports, method verification reports, method validation protocols & reports, working standard / impurity standard profile, analytical data of pilot bio batches, and method transfers protocol & report. - Review lab events, deviations, change controls, CAPA, and associated investigation reports before Technology Transfer. - Support and actively participate in failure investigations, identifying root causes for issues related to systems and products develope...
Posted 1 day ago
1.0 - 6.0 years
2 - 4 Lacs
vadodara, gujarat, india
On-site
Job description: An ADL (Analytical Development Laboratory) role in API job responsibilities includes developing and validating analytical methods for raw materials, intermediates, and finished APIs, performing routine Experience in analytical chemistry and method validation Develop and validate analytical methods for raw materials, intermediates, and finished APIs Location: Vadodara Employment Type: Full Time, Permanent Role Category: Research & Development - Other Education: UG: B.Sc in Any Specialization, B.Pharma in Any Specialization PG: MS/M.Sc(Science) in Any Specialization, M.Pharma in Any Specialization
Posted 2 days ago
2.0 - 5.0 years
3 - 6 Lacs
bengaluru
Work from Office
The successful candidate will be responsible for designing, developing, and optimizing OSD formulations, ensuring product quality, stability, and performance. Interested candidates please sent your resumes to email id: jones.naveen@insta-pill.com Food allowance Health insurance Office cab/shuttle Provident fund
Posted 3 days ago
7.0 - 12.0 years
10 - 18 Lacs
vadodara
Work from Office
Job Title: Executive Business Unit: R&D1 Regulatory Affairs Job Grade G12A Location : Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” JOB Description: - Method development & Validation by using sophisticated...
Posted 4 days ago
3.0 - 6.0 years
6 - 12 Lacs
aurangabad
Work from Office
Role & responsibilities Perform Mass Spectrometry (LC-MS/MS) analysis for structural and physio-chemical characterization of peptides/proteins (Intact mass, Peptide mapping, Sequencing) Operate and maintain high-resolution mass spectrometer (Q-TOF/Orbitrap/Relevant Instruments) Support characterization studies for biologics - Insulin and Insulin Analogues, Therapeutic proteins and Biosimilars Ensure proper compliance in line with GLP norms Preferred candidate profile Proficient in advanced proteomic analysis methods. Proficient in impurity analysis, top-down and bottom up proteomics Experience of using various advanced structural characterization methods (CE, CD, DSC, DLS, IR, AUC) would be ...
Posted 1 week ago
1.0 - 4.0 years
4 - 5 Lacs
mumbai
Work from Office
Role & responsibilities To perform the Characterization, Reliability and IVBE Dissolution Study of Nasal products at Ambernath unit Should have hands-on experience in performing the dissolution, assay & RS tests. To perform the calibration of instruments like dissolution apparatus, UV spectrophotometer, HPLC and GC, Dissolution, Spraytec and spray view instruments. Experience in testing Spray pattern and Droplet size distribution will be an added advantage Follow the system / operational SOPs. Ensure data integrity and accuracy of data generated. Should have knowledge of ICH and regulatory guidelines. Collaborate with different departments as per the requirements Preferred candidate profile ...
Posted 1 week ago
2.0 - 5.0 years
3 - 5 Lacs
visakhapatnam
Work from Office
The Role As an Analytical Development Associate, you will play a crucial role in the development and routine analysis of Active Pharmaceutical Ingredients (APIs) and their related materials. Your work will directly support our mission of bringing high-quality, life-saving medicines to market by ensuring our products meet stringent regulatory and quality standards. Key Responsibilities Method Development & Analysis: Perform method development and routine analysis of Key Starting Materials (KSMs), raw materials, intermediates, and drug substances using various analytical techniques, including KF (Karl Fischer), FT-IR, SOR (Specific Optical Rotation), and general wet analysis. Routine Operation...
Posted 1 week ago
4.0 - 8.0 years
3 - 7 Lacs
chennai
Work from Office
Roles and Responsibilities Develop analytical methods for pharmaceutical products using HPLC techniques. Conduct method development, validation, and transfer activities to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to resolve analytical issues and improve process efficiency. Design and execute experiments to optimize analytical protocols and validate results. Maintain accurate records of all experimental data, reports, and documentation. Desired Candidate Profile 4-8 years of experience in Analytical Research & Development (AR&D) or related field. Strong knowledge of analytical chemistry principles, including chromatography (HPLC), spectroscopy, e...
Posted 1 week ago
5.0 - 8.0 years
4 - 8 Lacs
thane, navi mumbai
Work from Office
Role & responsibilities 1. Candidate will be based at Pharma R&D Center at Thane and will Analytical Research and Development for Regulated & Row Market with focus on Injectable Dosage. 2. Candidate should have expertise in Analytical Method Validation and Method Development, Routine, Stability for Injectables for Regulated/ROW Market. 3. Experienced and responsible analytical development to develop and Validate new analytical methods for analysis of formulations Injectable dosage forms as per ICH guidelines. 4. Candidate have to support and troubleshooting in the development and validation of analytical methods working across the technical teams. (Routine, Stability, Method Development and ...
Posted 1 week ago
5.0 - 7.0 years
0 Lacs
hyderabad, telangana, india
On-site
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace ...
Posted 2 weeks ago
1.0 - 6.0 years
2 - 4 Lacs
vadodara
Work from Office
An ADL (Analytical Development Laboratory) role in API job responsibilities includes developing and validating analytical methods for raw materials, intermediates, and finished APIs, performing routine
Posted 2 weeks ago
5.0 - 10.0 years
5 - 11 Lacs
vadodara
Work from Office
Job Title: Executive – Analytical Development Business Unit: R&D1 Regulatory Affairs Job Grade G12A Location Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Job Description To work as per cGMP and ensure its...
Posted 2 weeks ago
1.0 - 3.0 years
3 - 4 Lacs
vijayawada
Work from Office
Role & responsibilities: We are looking for an energetic and Analytical R&D experienced candidate with good skills in handling HPLC, HPTLC, GC Etc. GLP experience will be an added advantage.
Posted 2 weeks ago
7.0 - 11.0 years
0 Lacs
hyderabad, telangana
On-site
You will be joining the Formulation R&D team at Hetero Drugs as a Scientist II, focusing on the development of sterile injectable formulations, including aqueous, non-aqueous, lyophilized, and peptide-based oncology products. Your role will be crucial in advancing product development for regulated markets such as the US, Europe, and ROW. You will be responsible for comprehensive formulation design, process optimization, regulatory documentation, and coordination across departments. - Independently lead the development of sterile injectable products, including aqueous, non-aqueous, lyophilized, and peptide-based formulations. - Conduct formulation studies, process optimization, and scale-up a...
Posted 2 weeks ago
2.0 - 6.0 years
0 Lacs
maharashtra
On-site
Role Overview: As an Analytical Development Scientist, you will be responsible for departmental operations and project delivery. You will work closely with the project lead and Analytical Development Manager to ensure efficient use of time, maintain laboratory areas, provide training and troubleshooting support, and engage in compliance and improvement projects. Your role will also involve leading aspects of projects, planning and carrying out work to ensure effective project progression, supporting method development, and providing project support for analytical development. Additionally, you will be responsible for ensuring timely close out of deviations, upholding cGMP principles and ESH ...
Posted 2 weeks ago
2.0 - 5.0 years
4 - 8 Lacs
greater noida
Work from Office
The Manager of Analytical Development will be responsible for developing and implementing analytical methods, quality control, conducting laboratory skills, method development, and research and development (R&D) activities.. No of Vacancies 1. Education Bachelors or Masters degree in Pharmacy, Chemistry, or related field.
Posted 3 weeks ago
10.0 - 15.0 years
10 - 20 Lacs
bengaluru
Work from Office
JOB DESCRIPTION We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products. RESPONSIBILITIES: • Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements • Provide regulatory direction on global regulatory requirements to support product development • Ensure all filings are maintained pe...
Posted 3 weeks ago
0.0 - 3.0 years
1 - 4 Lacs
hyderabad
Work from Office
Responsibilities: * Develop analytical methods using AD techniques. * Prepare analytical reports with accuracy. * Validate methods according to industry standards. * Transfer methods between instruments and locations. Office cab/shuttle Provident fund Health insurance
Posted 3 weeks ago
8.0 - 13.0 years
6 - 10 Lacs
hyderabad
Work from Office
The Scientific Communications Operations Manager is accountable for driving development, execution, and implementation of a wide scope of projects and technology solutions for Amgens Global Scientific Communications capability in India. Projects include execution of medical content and publications, literature surveillance, process improvements, AI and automation solutions, the integration of innovative tools and platforms into core processes, and training development and delivery. Reporting to the Scientific Communications Operations Senior Manager, this global position will manage and continue to evolve the Scientific Communications Project Management capability and will establish cross-fu...
Posted 3 weeks ago
2.0 - 4.0 years
3 - 7 Lacs
navi mumbai, india
Work from Office
Job Description: Will work in Analytical development Lab of BRL. Responsible for analytical deliverables of Biologics Projects for regulated markets. Deliverables involves but not limited to Method Development, Qualification, Technology transfer, Biosimilarity assessment, Forced degradation and Characterization activities. Responsible for Independent planning and execution of experiments. Techniques include but not limited to Chromatography, Electrophoresis, Spectrophotometry and Colorimetric assays for Biotherapeutics. Major responsibility will be planning and execution of HPLC, UPLC and CE based analysis Skill sets: Knowledge and hands-on experience of different chromatography modes like R...
Posted 3 weeks ago
2.0 - 4.0 years
0 Lacs
india
On-site
Find what drives you on a team with a more than 70-year history of discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers protect people. Our products serve a wide range of markets, so if your interests lie along the spectrum of Life Sciences to Industrial, you'll find a rewarding role here. For the exponentially curious, Pall is a place you can thrive and amplify your impact on the world. Pall is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we're pioneering the future of science and medicine, developing products that enable researche...
Posted 4 weeks ago
7.0 - 12.0 years
10 - 18 Lacs
gurugram
Work from Office
Job Title: Senior Executive – R&D Quality, CMC QA (Analytical) Business Unit: Global Quality & Compliance Job Grade G11B Location : Gurugram At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key responsibilities: Rev...
Posted 1 month ago
0.0 years
0 Lacs
mumbai, maharashtra, india
On-site
Role & responsibilities Nitrosamine and regulatory query support Conduct nitrosamine risk assessments for APIs, excipients, packaging components, and finished drug products. Evaluate manufacturing processes, raw materials, and excipients for nitrosamine risk. Review current regulatory guidelines (ICH M7, EMA, USFDA, CDSCO, WHO, and other ROW countries) and apply them in assessments. Prepare risk assessment and justification reports for internal and regulatory submission. Work with Analytical Development, Quality Assurance, Regulatory Affairs, and Formulation teams to collect and interpret required data. Support confirmatory testing strategies and assist in root cause investigations if nitros...
Posted 1 month ago
5.0 - 10.0 years
0 Lacs
karnataka
On-site
As an Upstream Manufacturing Documentation at Syngene, your role will involve leading the upstream process group to design and develop cell culture processes for monoclonal antibody and fusion protein production. You will provide expert leadership overseeing strategic and day-to-day activities in upstream process development of complex novel biologics. Your responsibilities will include overseeing technology transfer to support scale-up and GMP manufacturing, building strong relationships with CMOs, designing and executing risk-based process characterization studies, scaling up processes, preparing technology transfer protocols, collaborating with other teams, liaising with regulatory affair...
Posted 1 month ago
2.0 - 5.0 years
3 - 5 Lacs
ankleshwar
Work from Office
Responsibilities: * Develop analytical methods using ADL principles * Validate methods according to industry standards * Collaborate with cross-functional teams on method implementation Annual bonus Provident fund
Posted 1 month ago
 
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