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2.0 - 14.0 years

0 Lacs

karnataka

On-site

As a candidate for the position, you should possess a M. Pharm (Pharmacology/ Pharmaceutical Analysis) or M.Sc. (Biochemistry/ Pharmaceutical Chemistry) degree with 11-14 years of experience or a Ph.D. with 2-5 years of experience in the fields of large molecule/ADC PK and bioanalysis. Your expertise should include Antibody Drug Conjugate characterization and bioanalysis, mass spectrometry-HRMS, Q-TOF, and Triple quad. Your role will involve being an expert in designing and executing DMPK studies to support antibody-drug conjugate (ADC) and monoclonal antibody (mAb) programs, ranging from discovery to IND-enabling stages. You should have extensive experience in quantifying biologics such as antibodies, therapeutic proteins, ADCs, and peptides using LC-MS/MS, MSD, and ELISA platforms. Proficiency in advanced bioinformatics tools like BioPharma Finder, MaxQuant, Spectronaut, and other relevant analytical software is essential. Your responsibilities will also include applying innovative techniques for identifying and selecting ADC and mAb lead candidates based on their functions, with a strong emphasis on DMPK profiling to ensure the safe and effective development of therapeutics. You should be adept at interpreting complex DMPK data and providing actionable insights to cross-functional project teams. Active representation of DMPK functions in internal and external meetings to promote collaboration and strategic alignment is crucial. Collaboration with cross-functional departments to address ADC-related challenges and provide integrated solutions from target validation to IND submission will be part of your role. You will be accountable for authoring and reviewing SOPs, study protocols, reports, and regulatory documentation to support both GLP and non-GLP studies. A strong foundational knowledge of DMPK principles including PK/PD, toxicology, and translational sciences is required. Demonstrated capabilities in communication, innovation, and team leadership will be essential for success in this position.,

Posted 2 days ago

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3.0 - 7.0 years

0 Lacs

navi mumbai, maharashtra

On-site

As a Quality Analyst I at Teva Pharmaceuticals, you will be responsible for auditing each BA/BE study to ensure that facilities, personnel, equipment, instruments, protocols, methods, practice, records, and controls comply with relevant GCP/GLP guidelines, protocols, and SOPs. Your day will involve reviewing SOPs, forms, logbooks of departments, providing feedback, reviewing change control and deviations, and preparing audit reports in accordance with guidelines and regulatory inspections. You will also conduct in-process study audits to ensure compliance with GCP/GLP, protocols, SOPs, and regulatory requirements. Additionally, you will audit raw data, validation reports, bioanalytical reports, PK and statistical outputs, bio-summary tables, eCTD compilations, and collaborate with Biostatisticians and medical writers for finalization of reports. Furthermore, you will review audit trails on LC-MS/MS instruments, conduct area-specific audits, system audits, vendor audits, calibration records, and issue documents such as SOPs, protocols, and logbooks. Your role will involve ensuring compliance and adherence to quality standards in bioanalytical processes. To qualify for this role, you should have a B.Pharm, M.Pharm, or M.Sc degree with 3-6 years of experience in Bioanalytical Quality Assurance for a BA/BE Study. Join us on our mission to make good health more affordable and accessible, impacting millions of lives worldwide. Apply now to be a part of Teva Pharmaceuticals and contribute to our commitment to Equal Employment Opportunity.,

Posted 3 days ago

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3.0 - 7.0 years

0 Lacs

telangana

On-site

As an In vitro Bioanalytical Scientist at Syngene, based in Hyderabad, you will be responsible for participating in sample processing for PK and ADME assays, as well as handling LCMS/MS. Your role will involve adapting to a dynamic team environment, processing various matrices samples for PK studies, optimizing test compounds manually and automated on LCMS/MS, and independently handling HPLC for UV-based sample analysis. Additionally, you will be expected to develop methods with the team lead, document lab notebooks online, and manage compounds effectively. You will need to demonstrate expertise in column selection, mobile phase selection, solvent preparations, and sample processing techniques such as protein precipitation, liquid-liquid extraction, and solid-phase extraction. It is essential to have experience in handling ADME assays and HPLC and LCMS/MS, with a minimum of 3-5 years of relevant experience. Moreover, you should be capable of developing and validating LC-MS based qualitative/quantitative methods, conducting internet-based literature searches, and interpreting Mass/UV Spectra. As a part of the Syngene team, it is mandatory to adhere to safety guidelines, procedures, and SOPs, ensuring the safety of yourself, teams, and the lab/plant at all times. You must also complete all assigned mandatory trainings related to data integrity, health, and safety measures promptly. Furthermore, you will be expected to comply with Syngene's quality standards, hold yourself and your teams accountable for safety goals, and review safety metrics periodically. Syngene values excellence, integrity, and professionalism, and expects all employees to consistently demonstrate alignment with these core values. As a leader at Syngene, you will champion effective Environment, Occupational Health, Safety, and Sustainability (EHSS) practices, foster a corporate culture promoting an EHSS mindset, and uphold the highest standards of quality, integrity, and compliance. The ideal candidate for this role should possess a M. Pharm in Pharmaceutical Sciences or Pharmaceutical Analysis with a passion for LC/MS related bioanalysis. You should have a general understanding of drug metabolism and pharmacokinetics, be able to deliver scientific presentations, and write official project reports. Additionally, you should ensure preventative maintenance and calibration schedules of HPLC and mass spec by coordinating with vendors and support staff. Syngene is an equal opportunity employer, committed to providing integrated scientific services from early discovery to commercial supply, with safety as a top priority in all aspects of operations.,

Posted 4 days ago

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2.0 - 6.0 years

0 Lacs

karnataka

On-site

As a Research Scientist1 DMPK at the Foundation for Neglected Disease Research in Bengaluru, you will play a crucial role in supporting drug discovery and development projects by performing and analyzing in vitro and in vivo DMPK studies. Your responsibilities will include planning, designing, and executing DMPK experiments, maintaining laboratory instruments, and preparing protocols. Additionally, you will be tasked with writing reports, communicating with the project team, and presenting DMPK data during project meetings. Your technical skills will be put to the test as you set up and conduct physiochemical assays, in vitro DMPK assays, and bioanalytical methods. Your experience in analyzing in-vivo pharmacokinetic samples and familiarity with sample processing techniques will be invaluable. Proficiency in handling LC-MS/MS for quantitative analysis, protocol preparation, and report writing is essential for this role. Moreover, your additional experience in animal handling, conducting PK studies, and working with cell lines such as Caco-2 will be advantageous. Knowledge of interpreting pharmacokinetic data using Phoenix WinNonlin and operating in a GLP or GLP-like environment will also be beneficial. Basic skills required for this position include working independently with enthusiasm, strong decision-making and problem-solving abilities, effective collaboration across multidisciplinary functions, and knowledge of drug discovery and development processes. Excellent oral, written, and interpersonal communication skills in English, along with proficiency in computer applications, are essential for success in this role. To be considered for this position, you must be an Indian citizen with an M.Pharm, MS (Pharm), or PhD qualification and possess 2 to 5 years of industry experience. The salary offered will be commensurate with your experience. If you meet the qualifications and are excited about this opportunity, please submit your resume to hr@fndr.in with the subject line "Application for Research Scientist 1 DMPK," including your notice period, current location, and current and expected CTC in the body of the email. We look forward to receiving your application.,

Posted 6 days ago

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2.0 - 6.0 years

0 Lacs

kolkata, west bengal

On-site

You will be responsible for providing drug metabolism and pharmacokinetic support for discovery programs. Your main duties will include monitoring Pharmacokinetics studies, supporting bioanalysis, and offering pre-clinical ADME lead optimization support to small molecule Drug Discovery programs across various therapeutic areas. You will be working as a DMPK subject matter lead in multidisciplinary/cross-functional teams to understand the Chemical Structure ADME relationships and design appropriate strategies to enhance the Drug like Properties of the New Chemical Entities. To be successful in this role, you should have 2-5 years of experience in GLP with either an M.Sc. or Ph.D. degree. You should possess expertise in Bioanalysis using LC-MS/MS in both GLP and non-GLP environments. Additionally, you should be capable of leading projects as a DMPK representative, quantifying small molecules using LC-MS/MS, and conducting metabolite identification work on High-resolution mass spectrometry. Qualifications required for this position include an M. Pharm (Pharmacology / Pharmaceutical Analysis) or an M.Sc. (Biochemistry / Pharmaceutical Chemistry).,

Posted 6 days ago

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2.0 - 6.0 years

0 Lacs

karnataka

On-site

The key responsibility of the candidate will be to perform and analyze in vitro and in vivo DMPK studies to support drug discovery and development projects. You will be involved in planning, designing, and setting up DMPK experiments, handling instruments, maintaining the laboratory, and preparing and reviewing protocols. Furthermore, you will be responsible for writing reports, communicating with the project team, and presenting DMPK data in project meetings. Required technical skills include the ability to set up and perform physiochemical assays such as solubility and logP, experience in conducting in vitro DMPK assays (microsomal and hepatocyte stability, plasma stability, CYP inhibition, blood/plasma ratio), development and validation of bioanalytical methods across various biological matrices, analysis of in-vivo pharmacokinetic samples, knowledge of sample processing techniques (protein precipitation, liquid-liquid extraction, solid-phase extraction), proficiency in handling LC-MS/MS for quantitative analysis, protocol preparation, report writing, and presentation of DMPK data in scientific team meetings. Additional skills that would be beneficial for this role include experience in animal handling, conducting pharmacokinetic (PK) studies, working with cell lines such as Caco-2, ability to interpret pharmacokinetic data using Phoenix WinNonlin, experience in a GLP or GLP-like environment. Basic skills required for this position include the ability to work independently with enthusiasm and self-motivation, strong decision-making and problem-solving skills, effective collaboration and teamwork across multidisciplinary functions, knowledge of drug discovery and development processes, excellent oral, written, and interpersonal communication skills with proficiency in English, and proficiency in computer applications including word processing, spreadsheets, and presentation tools. Qualifications for this role include an M.Pharm or MS (Pharm) or PhD degree, industry experience of 2 to 5 years, and the candidate must be an Indian citizen. Salary will be commensurate with experience.,

Posted 2 weeks ago

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1.0 - 5.0 years

0 Lacs

karnataka

On-site

As a Research Associate/ Executive/ Analyst in the Small Molecule Bioanalytical Research Laboratory at Syngene International Ltd., you will be responsible for conducting BA/BE studies in the laboratory. Your role will involve critical method development and validation programs, ensuring technical and regulatory compliance in all studies. To excel in this position, you should have a strong background in pharmaceutics or related life sciences, along with extensive experience in the bioanalytical field, specifically in small molecule bioanalysis. Your commitment to compliance, integrity, and excellence in bioanalytical research, particularly in small molecule analysis, will be essential for success in this role. Key responsibilities include performing bioanalytical work such as sample processing for method development, method validation, and study sample analysis in compliance with SOPs and STPs. You will be required to prepare STP, MV protocol, and study sample analysis protocol, as well as coordinate with the maintenance department for any equipment failures. Documenting data generated and ensuring adherence to regulatory guidelines set by GCP/GLP will also be part of your responsibilities. To qualify for this role, you should hold a Masters in Pharmaceutics or related life sciences from a reputed university, along with a minimum of 1 year of experience in regulated small molecule bioanalysis. Hands-on experience in small molecule regulated bioanalytical experiments is crucial for this position. Additionally, having experience working in a Bioanalytical CRO lab will be considered an advantage. Core competencies required for this role include scientific expertise, technical proficiency, and strong documentation skills. You should be able to bring a creative and innovative advantage to projects, think scientifically, and conduct experiments effectively. Syngene International Ltd. is an equal opportunity employer committed to fostering a diverse and inclusive workplace. If you are interested in joining our team and contributing to cutting-edge bioanalytical research, please visit our website at https://syngeneintl.com/ for more information about our company and the work we do.,

Posted 3 weeks ago

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2.0 - 3.0 years

2 - 4 Lacs

Alleppey, Cherthala

Work from Office

Need an Analyst for a laboratory in Aroor. must have experience in handling LCMSMS/GCMSMS/ICPMS instrument at least 2 to 3 years. need to join immediately.

Posted 3 weeks ago

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2.0 - 3.0 years

2 - 3 Lacs

Alleppey, Cherthala

Work from Office

Need an Analyst for a laboratory in Aroor. must have experience in LCMSMS/GCMSMS/ICPMS instrument at least 2 to 3 years. need to join immediately.

Posted 2 months ago

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- 3 years

2 - 5 Lacs

Hyderabad/ Secunderabad

Work from Office

Walk-In Drive : Analytical Services Required Qualification & Experience: M.Sc. Chemistry/Analytical/M-Pharmacy, with 0 - 3 Years of experience in the field of pharmaceutical industry/CRO setup. Candidate should have knowledge in method development and validations by GCMS /LC-QTOF. Candidate should have knowledge on GLP/cGMP. Good to have experince in E&L. Job Responsibilities Carries out experimentation in the area of GCMS/LC-QTOF for E&L studies. Records experimental data, ensuring clear and accurate transcription of results and calculations. Completes assigned work with quality and in a timely manner. Assists the group leader in instrument qualifications, implementing laboratory procedures and systems. Coordinates with other team members as per requirement. Follows QMS (cGMP/GLP) practices and aspects related to policies, safety and compliance. Performs in-charge duties for the allocated lab/equipment/inventory/supporting activities and takes responsibility for the timely completion of the tasks assigned. Demonstrates a strong desire to continue learning and grow personal capability. Performs other duties as assigned. Please bring your Updated CV along with 3 Months Payslips, Recent Increment Letter, Aadhar Card/PAN Card: Date : Saturday, 17th May 2025 Time: 09:00 AM to 4:00 PM Walk-in Interview Location: Daicel Chiral Technologies (India) Pvt Ltd Genme Valley, IKP Knowledge Park, Survey No. 542/2, Koltur Village, Shamirpet Mandal, Medchal-Malkajgiri District, Hyderabad-500101 Note: Candidates who are unable to walk-In, May send their resume to hr@chiral.daice.com or whatsApp to 7207760479

Posted 2 months ago

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15 - 20 years

10 - 15 Lacs

Gurugram

Work from Office

Overall technical & operational activities of entire laboratories and coordination with the all Lab HODs related samples & test report reviewing and reporting results of performed analysis and timely deliver with accurate result and provide guidance to the customer if required and also negotiation with chemical & Instrument suppliers. Good Knowledge of latest instruments such as LCMSMS, HPLC, GC, GCMS, GC-HS, ICP-MS, ICP-OES etc. Coordination with QA team for implementing and maintaining the QMS as per ISO/IEC 17025:2017. Documentation for the upcoming audit for the bodies such as NABL, MoEF, CPCB, BIS, FDA, FSSAI, GLP, Ministry of Ayush, CDSCO etc. And proper closure of client complaint & NCs. Maintain TAT with accuracy as per quality system as well as client requirement. Conducting internal audits and provides training to the laboratory staff and Participation in regulatory meetings. Business development activities for testing samples of food and agriculture, pharmaceuticals, environmental parameters and footwear products. Build and maintain relationships with customers and Schedule regular follow-ups. and check-ins to ensure client satisfaction and identify new opportunities.

Posted 2 months ago

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