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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.,

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3.0 - 8.0 years

4 - 9 Lacs

Bengaluru

Work from Office

Role & responsibilities Experience Minimum 3-5 years of experience in handling ADME assays and HPLC and LCMS/MS Skills and Capabilities Expertise in column selection, mobile phase selection, solvent preparations and sample processing techniques such as protein precipitation, liquid-liquid extraction and solid phase extraction is mandatory Sample processing of New chemical entities from various in-vitro and in-vivo studies executed in Preclinical discovery by using appropriate extraction methods Should be able to develop and validate LC-MS based qualitative/quantitative methods and apply them in routine analysis Should be well versed with internet-based literature search and capable of implementing the Learnings as and when required Candidate is expected to have basic understanding in interpretation of Mass/UV Spectra Should ensure preventative maintenance and calibration schedules of HPLC & mass spec by coordinating with vendor and support staff General understanding of Drug metabolism and Pharmacokinetics Should be able to deliver scientific presentation in departmental journal club and write official Project reports Preferred candidate profile M. Pharm in Pharmaceutical sciences, Pharmaceutical Analysis who has interest and passion for LC/MS related bioanalysis.

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3.0 - 8.0 years

4 - 9 Lacs

Hyderabad, Bengaluru

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Job Title: Invitro BA Scientist Job Location: Bangalore, Hyderabad' About Syngene : Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines • Overall adherence to safe practices and procedures of oneself and the teams aligned • Contributing to development of procedures, practices and systems that ensures safe operations and compliance to companys integrity & quality standards • Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. • Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. • Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self • Compliance to Syngene s quality standards at all times • Hold self and their teams accountable for the achievement of safety goals • Govern and Review safety metrics from time to time Core Purpose of the Role : • To participate in sample processing for PK, ADME assays and handling of LCMS/MS. Ability to adapt to the dynamic team environment • Processing of different matrices samples of PK studies • Optimization of test compounds manually as well as automated on LCMS/MS • Develop methods with the team lead • Independently handling of HPLC for UV based samples analysis. • Documenting the lab note books online and compound management Syngene Values All employees will consistently demonstrate alignment with our core values ' Excellence Integrity Professionalism Experience 3- 10+years Education : Msc/Pharm/Mtech/Phd/ Fresh phd with relevant exp during academics or any postdoc Skills and Capabilities • Expertise in column selection, mobile phase selection, solvent preparations and sample processing techniques such as protein precipitation, liquid-liquid extraction and solid phase extraction is mandatory • Sample processing of New chemical entities from various in-vitro and in-vivo studies executed in Preclinical discovery by using appropriate extraction methods • Should be able to develop and validate LC-MS based qualitative/quantitative methods and apply them in routine analysis • Should be well versed with internet-based literature search and capable of implementing the Learnings as and when required • Candidate is expected to have basic understanding in interpretation of Mass/UV Spectra • Should ensure preventative maintenance and calibration schedules of HPLC & mass spec by coordinating with vendor and support staff • General understanding of Drug metabolism and Pharmacokinetics • Should be able to deliver scientific presentation in departmental journal club and write official Project reports

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4.0 - 6.0 years

4 - 7 Lacs

Pune

Work from Office

Develop, implement & maintain a robust Quality Management System (QMS) in compliance with applicable regulations (GLP, GCP, GXP, ICH guidelines) Create, review, and manage SOPs, work instructions, protocols, reports & documentation across departments Required Candidate profile 4+ years of experience in QA/QC within the pharmaceutical, biotech or drug discovery industry. Quality control certifications are preferred In depth understanding of QA/QC procedures & legal standards

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2.0 - 7.0 years

3 - 8 Lacs

Hyderabad, Bengaluru

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Job Title: Invitro Bioanalytical Scientist Job Location: Bangalore/Hyderabad About Syngene : Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to companys integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role : To participate in sample processing for PK, ADME assays and handling of LCMS/MS. Ability to adapt to the dynamic team environment Processing of different matrices samples of PK studies Optimization of test compounds manually as well as automated on LCMS/MS Develop methods with the team lead Independently handling of HPLC for UV based samples analysis. Documenting the lab note books online and compound management Role Accountabilities Leadership Capabilities Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Accountabilities as a Syngene Leader (only for Leadership Hires) Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities. Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance. Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority. Specific requirements for this role 1. Experience 2. Demonstrated Capability 3. Education Experience Minimum 3-5 years of experience in handling ADME assays and HPLC and LCMS/MS Skills and Capabilities Expertise in column selection, mobile phase selection, solvent preparations and sample processing techniques such as protein precipitation, liquid-liquid extraction and solid phase extraction is mandatory Sample processing of New chemical entities from various in-vitro and in-vivo studies executed in Preclinical discovery by using appropriate extraction methods Should be able to develop and validate LC-MS based qualitative/quantitative methods and apply them in routine analysis Should be well versed with internet-based literature search and capable of implementing the Learnings as and when required Candidate is expected to have basic understanding in interpretation of Mass/UV Spectra Should ensure preventative maintenance and calibration schedules of HPLC & mass spec by coordinating with vendor and support staff General understanding of Drug metabolism and Pharmacokinetics Should be able to deliver scientific presentation in departmental journal club and write official Project reports Education M. Pharm in Pharmaceutical sciences, Pharmaceutical Analysis who has interest and passion for LC/MS related bioanalysis.

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8.0 - 13.0 years

0 - 0 Lacs

Bengaluru

Work from Office

Exciting Opportunity Alert - DMPK Roles at Syngene International! Are you passionate about drug discovery and eager to contribute to cutting-edge pharmaceutical research? Join us at Syngene International for the following roles: - ADME Scientist: MSc with 6-9 years or MPharma/Mtech with 3-6 years - Sr AS: MSc with 9-12 years, MPharm/Mtech with 6-9 years - Team Lead: Fresh PhD or MSc with 15-16 years, MPharma with 12-15 years - Sr Team Lead: PhD with 3-5 years of experience - Group Lead: PhD with 5-10 years - Senior Group Lead: PhD with 10+ years Fresh PhD candidates with relevant experience during academics or postdoc are also welcome. Key Skills Required: DMPK In vitro BA and In vitro ADME Kindly note that there are no current requirements for "In vivo BA" and "In vivo PK" positions. Please share your resumes at: Sulake.Divyasree@Syngeneintl.com Core Purpose of the Role: Lead the team of bioanalysts responsible for delivering high quality data for requested ADME studies withing agreed timelines Expertise in automated discovery bioanalysis workflow practices for both small and large molecules and new drug modalities like Protacs, ADCs, Oligonucleotides etc. Updated with the latest innovations in high throughput bioanalysis, both at instruments levels and data management Sound understanding of DMPK principles and have mandatory experience in handling global clients Comprehend outcome of various in-vitro/in-vivo assays and contribute to integrated drug discovery Projects as DMPK representative

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4.0 - 9.0 years

5 - 10 Lacs

Hyderabad

Work from Office

Greetings from Vivo Bio Tech Ltd! Job Responsibility: Study Director Job Title: Scientist/Senior Scientist Company: Vivo Bio Tech Ltd Location: Hyderabad Experience: 4-10 Years Education: Postgraduate (Life Sciences/Pharmacology/Toxicology or related fields) Vivo Bio Tech Ltd is seeking experienced Study Directors to lead and manage Preclinical studies in accordance with GLP and CRO regulatory guidelines . The role involves planning, execution, monitoring, and reporting of the experienced departments below: 1.Toxicology 2.Bio Analytical 3.Analytical Chemistry Job Requirements: Postgraduate degree in Life Sciences or related discipline. 4-10 years of relevant experience in Preclinical with CRO and GLP studies . Strong understanding of regulatory guidelines and data integrity practices. Excellent analytical, communication, and project management skills.

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0.0 - 3.0 years

2 - 3 Lacs

Chengalpattu, Chennai

Work from Office

Production: Execute production batches, ensure GMP, manage documentation QA: Ensure cGMP, Issuance and retrievals and manage records. QC: Analyze biopharma samples & maintain Documentation R&D: Prepare stocks and buffers, extract proteins & analyze.

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3.0 - 6.0 years

4 - 6 Lacs

Bengaluru

Work from Office

Preferred candidate profile M. Pharm (Pharmacology / Pharmaceutical Analysis) / M.Sc. (Biochemistry / Pharmaceutical Chemistry / Analytical Chemistry) with 3 - 6 years experience in Bioanalytical DMPK & Invivo PK. Role & responsibilities Planning and execution of invivo preclinical pharmacokinetic studies, invivo tissue distribution & mass balance studies in rodents. Expert in method development of NCEs using LC-MS/MS system Well verse with extraction techniques of molecules from various matrices like plasma/urine/tissues Experienced in surgical skills for rodents PK, excretion studies Conduct Bioanalysis of samples from in-vivo pharmacokinetic, tissue distribution studies, PK-PD & TK studies through LCMS/MS Prepare protocols and SOPs in line with industrys best practices Very strong in basics of all instruments, principles of chromatography, sample processing Knowledge of Phoenix WinNolin software will be added advantage

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2.0 - 5.0 years

7 - 11 Lacs

Bengaluru

Work from Office

D organization dedicated to developing novel therapeutics, diagnostics and devices for diseases with a high socio- economic impact. Roles and Responsibilities: 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. The candidate will be involved in planning, designing and set-up of DMPK experiments, handling instruments, maintaining the laboratory and preparing and reviewing the protocol. He/ she will also be responsible for writing reports and communicating with the project team and presenting DMPK data in the project meetings. Technical Skills Ability to set up and perform physiochemical assays such as solubility and logP Experience in conducting in vitro DMPK assays, including microsomal and hepatocyte stability, plasma stability, CYP inhibition, and blood/ plasma ratio Skilled in the development and validation of bioanalytical methods across various biological matrices Experience in analysis of in-vivo pharmacokinetic samples Knowledge of sample processing techniques such as protein precipitation, liquid-liquid extraction, and solid-phase extraction Proficient in handling LC-MS/MS for quantitative analysis Experience in protocol preparation and report writing Presentation of DMPK data in scientific team meetings Additional: Experience in animal handling and conducting pharmacokinetic (PK) studies skilled in maintaining and working with cell lines such as Caco-2Ability to interpret pharmacokinetic data using Phoenix WinNonlin Experience in working in a GLP or GLP-like environment Basic Skills required 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 Proficient in computer applications including word processing, spreadsheets, and presentation tools Other Information Candidate must be an India citizen Money Salary will be commensurate with experience. Qualification M.Pharm or MS (Pharm) or PhD Experience Industry experience of 2 to 5 years

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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.,

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4.0 - 6.0 years

0 - 0 Lacs

Thane, Navi Mumbai

Work from Office

Role & responsibilities Should perform sample processing smoothly as well as project execution with in assign time. Should handle instrument as well as QA observation. Should coordinate with Group members/ Group leader/ Lab manager Should be able to inspect raw data as per defined procedure. Should report inspection result properly. Should verify calibration record. Should maintain GLP in Lab. Preferred candidate profile 5-6 Years of Experience in Clinical Research Organizations only (Bio-Analytical Department) Qualification: MSC Immediate to 20 days joiners are preferred. You can also share your resumes on: pradnya.raut@accutestglobal.com for quicker callback

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5.0 - 7.0 years

5 - 7 Lacs

Ahmedabad

Work from Office

ORGANISATIONAL OVERVIEW Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. JOB DETAILS Department: Bioanalytical Operations Designation: Research Associate Job Location: Ahmedabad (Gujarat) Education: M.Pharm/B.Pharm Experience: 5 to 7 years CTC Range: 5 to 7 Lacs Job Description: Ensure project coordination and conduct the study as per protocol and SOPs requirements. Work in close coordination with the Principal Investigator and Study team. Review of study protocol, ICF, CRF and other appendices (applicable in case of Special studies). Handling study related IMPs and its relevant documents (IP retrieval, verification, accountability, dispensing etc.). Communicate with sponsors, other departments and team on appropriate aspects of the clinical studies. Compile and complete raw data in TMF and resolve all QA/QC queries in timely manner. COMPETENCIES Accountability Communication Work Ethic Presentation / Communication skills Organizational Culture fit

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2.0 - 5.0 years

3 - 7 Lacs

Hyderabad

Work from Office

Junior Scientist ?? Analytical Development (IP) Location: Hyderabad Experience: 2-5 years About the Role: Join our analytical development team to ensure high-quality analysis and method development for For . Ltd.. Get In Touch Page load link |pharmaceutical products. Key Responsibilities: Perform analysis using UV/HPLC, GC, and dissolution techniques. Validate test procedures (dissolution, assay, related substances, etc.). Maintain error-free documentation and calibrated instruments. Apply Now Location:Hyderabad Experience:2-5 years Phone: +91 040 2379 2190 Email: info@aizant.com |Business Inquiries: bd@aizant.com Development Pre-Formulation Formulation Development Analytical Development Regulatory Support & Dossier Compilation Manufacturing Clinical Trial Material Commercial Supplies Technology Transfer Clinical Research Bioanalytical BABE Clinical Trial Services Our Portfolio Co-Development Out-licensing About Us Quick Links Careers We are hiring Social responsibility Sustainability Environment, Health & Safety Knowledge Hub Contact Us Copyright 2025 All Rights Reserved | Aizant Drug Research Solutions Pvt

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4.0 - 6.0 years

8 - 10 Lacs

Ahmedabad

Work from Office

ORGANISATIONAL OVERVIEW Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. Act as Senior Analyst in Bioanalytical Biosimilar Department Department : Bioanalytical- Proteins & Biosimilars Designation: Executive Location : - Ahmedabad Education : M.SC Biotechnology/ Biochemistry Experience: 4-6 yrs. CTC range : 8-10 Lac/annum Job description: Act as a Senior analyst for method validation and studies for LBA PK methods. Candidate has ability to develop and validate of LBA based bioanalytical PK methods and handling of 2 Project/MV activity together with 2-3 analyst team. Analyze serum samples clinical studies as per respective draft/method SOPs. Independent execution of ELISA / ligand binding assays, Collate, analyze and interpret data. Troubleshoot technical challenges during conduct of MD/MV/Projects. Review or prepare Method SOPs, BA-PBS SOPs, Study Plans, Analytical Reports and Validation Reports. Assist in reconciliation of study or MV raw data, Respond to QA and QC communications for in study or in process audits. Management of inventory for critical reagents or study specific general reagents. COMPETENCIES Accountability Communication Work Ethic Organizational Culture fit Initiative

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10.0 - 15.0 years

12 - 22 Lacs

Bengaluru

Work from Office

Role & responsibilities Working with a collaborative Bioanalytical team on large molecule analysis for established assays and working on novel analytical platforms and ideas for PK/TK, PD (Biomarkers), ADA and Nab (Cell based and non-cell based). Ensure regulatory compliance across all bioanalytical programs, adhering to GLP & GCLP standards for method development, transfer, validation, and sample analysis for biologics. Ensure the technical compliance of programs by adhering to latest guidelines and white papers, maintaining high-quality deliverables and adherence to project timelines. Independently manage studies and team, from executing studies to technical data review, analysis, and interpretation using advanced software tools. Engage in technical forecasting, troubleshooting, client interactions, and strategic planning to ensure the successful execution of programs. Work collaboratively across various functions within the laboratory and departments within Syngene - BD, Quality, Logistics, etc Preferred candidate profile Minimum of 5 years of direct experience in large molecule bioanalysis, with a strong focus on ligand binding assays, biological assays, and cell-based assays. Demonstrated success in regulatory audits and dossier submissions related to bioanalytical studies. Experience in a GLP/GCLP bioanalytical laboratory. Perks and benefits

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1.0 - 3.0 years

1 - 4 Lacs

Bengaluru, Manipal

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Role & responsibilities Development and validation of bioanalytical methods using LCMS and other sophisticated instruments. Routine calibration of the instruments. Strong basic knowledge about Analytical instruments of LCMS, HPLC, HPTLC, GC-MS and other instruments. Good understanding of GLP and documents thereof. Knowledge of USFDA guidelines. Excellent communication skills & co-ordination among all the team members. Should possess good interpersonal and management skills Accountable for the whole group productivity in terms of number of samples, analysis, quality, quantity timelines better Turn Around Time (TAT) improvement Preferred candidate profile The candidate should have 1-3 years of experience in Bioanalytical Lab.

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6.0 - 8.0 years

4 - 5 Lacs

Bengaluru

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Roles and Responsibilities Develop new products by formulating, developing, and launching solid oral products. Conduct bioanalytical testing to ensure product quality and stability. Collaborate with cross-functional teams for process development, PDR (Process Development Research), MFR (Manufacturing Formulation Research), FD Trial (First Time Right Trial). Ensure compliance with regulatory requirements through documentation of SOPs, BPRs, and batch records. Provide technical support to production team on product-related issues.

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3.0 - 7.0 years

2 - 4 Lacs

Nagpur

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Key Responsibilities 1. Dossier Preparation and Submission CTD/eCTD Compilation: Assemble and submit regulatory dossiers in Common Technical Document (CTD) format, including modules for clinical, non-clinical, and quality data.

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0.0 - 2.0 years

1 - 3 Lacs

Ahmedabad

Work from Office

BASIC SKILLS AND ABILITIES REQUIRED Demonstrate ability to pipette accurately. Knowledge of all basic of ELISA, instrumentation such as centrifuge, vortexer, shaker, Milli Q water system, Analytical Balance, freezer, refrigerator, water bath, volumetric flask, microplate washer, microplate reader and other lab related activities etc. Also demonstrate ability of handling biological samples, reagents as well as working/reference standards. MINIMUM EDUCATION, TRAINING AND EXPERIENCE REQUIRED A minimum of B.Sc or equivalent education unless demonstrated competence through work experience. SUPERVISED BY Project Manager SUPERVISES None. PRINCIPAL DUTIES AND RESPONSIBILITES Note: These statements reflect the general description of the position and are not intended to be an all-inclusive list of tasks to which the employee may be assigned. I RESPONSIBILITES A. Responsible as sample handling person for activities like recipient and storage of study samples, blank matrices and bulk spiked samples. Also will be responsible for labeling, retrieval, restorage, retention, shipment and disposal of study samples and bulk spiked samples as required and for the relevant documentation of sample handling activities. B. All activities related to reference standard, volumetric flask, analytical balance, centrifuge, vortexer, shaker, Milli Q water system, freezer, refrigerator, pipette, microplate washer, microplate reader etc. along with their maintenance record. C. To ensure the availability of first aid box and proper functioning of safety equipments in laboratory. D. Preparation of In-house ??Certificate of Analysis¢? for working/Reference standards. E. Issuance and recipient of Working/Reference standards. F. Maintenance of temperature monitoring devices. G. Maintain inventory of laboratory equipment spares. H. Assess and ensure adequate recourses are in place. I. Coordinate with lab personnel for smooth functioning of day to day lab activities. J. To supervise the glassware cleaning activity and laboratory store.

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0.0 - 2.0 years

2 - 4 Lacs

Ahmedabad

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ORGANISATIONAL OVERVIEW Lambda Therapeutic Research is a full-service Global Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Pittsburgh (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. JOB DETAILS Department: Bioanalytical- Protiens & Biosimilars Designation: Research Associate Job Location: Ahmedabad (Gujarat) Education: M.Pharm/B.Pharm or M.Sc. Experience: 0 to 2 years CTC Range: 3 to 4 Lacs Key Responsibilities: Design and execute experiments to assess the PK and immunogenicity of therapeutic compounds using a variety of assays and methodologies. Develop and validate bioanalytical methods for the detection and quantification of anti-drug antibodies (ADA) and neutralizing antibodies (NAb). Collaborate with cross-functional teams to plan and conduct immunogenicity studies, ensuring compliance with regulatory guidelines. Analyze and interpret data, generate scientific reports, and present findings to internal teams and external stakeholders. Stay up-to-date with the latest advancements in immunogenicity bioanalysis and contribute to the development of innovative approaches. Maintain laboratory equipment, ensure data integrity, and adhere to quality control and safety protocols. Participate in regulatory submissions and assist in interactions with sponsor audits as needed. COMPETENCIES Communication Work Ethic Organizational Culture fit Accountability

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2.0 - 6.0 years

4 - 8 Lacs

Noida

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The Position Organization : - Jubilant Biosys Designation & Level: - Research Associate/ Sr. Research Associate (A3/A4) Location: - Greater Noida Department: - DMPK Key Responsibilities In Vitro ADME studies Read and understand various in vitro ADME protocols Conduct in vitro stability (liver microsomes, plasma and in any other relevant matrix, chemical stability) experiments for new chemical entities Conduct the following in vitro ADME experiments logP, logD, pKa measurements CYP induction and inhibition assays Permeability determinations (Caco-2, MDCK etc) in relevant cell lines CYP phenotyping in purified enzyme systems Solubility determinations (kinetic, thermodynamic, simulated fluids) Bioanalysis : Read and understand the bioanalysis sections in the study protocols LC-MS/MS and HPLC-UV/PDA method development and validation (partial and complete) Developing fit-for-purpose LC-MS/MS methods for routine in vitro sample analysis Extracting data from the instrument, conducting bioanalytical QC and sharing of report with the stakeholders within the DMPK department Experience in handling bioanalytical method development for various matrices with focus on in vitro samples; understanding to handle plasma, blood, various tissues, urine, faeces etc. is a plus but not mandatory. Development LC-MS/MS methods for biochemical and cell based screening of NCEs is a plus but not mandatory General LC-MS/MS and HPLC maintenance and troubleshooting Data analysis and report generation: Understand the quality of bioanalytical data Conduct data analysis employing Phoenix WinNonLin software is a plus but not mandatory Ability to calculate in vitro results/ parameters on excel spreadsheets Report generation (excel format, word format and PowerPoint presentation) and sharing with the line manager Generate reports in both GLP and non-GLP formats (based on the requirement) Person Profile Qualification: - M.Sc /M.Tech (Biochemistry, Pharmaceutical Chemistry, Biotech background) Master in Pharmacy (M.Pharm) Experience: - 2- 6 years of relevant experience. Experience in a drug discovery industry/ CRO in DMPK department. Jubilant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, colour, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion or any other characteristic protected by applicable local laws, regulations and ordinances.

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2.0 - 6.0 years

4 - 8 Lacs

Noida

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" The Position Organization : - Jubilant Biosys Designation Level: - Research Associate/ Sr. Research Associate (A3/A4) Location: - Greater Noida Department: - DMPK Key Responsibilities In Vitro ADME studies Read and understand various in vitro ADME protocols Conduct in vitro stability (liver microsomes, plasma and in any other relevant matrix, chemical stability) experiments for new chemical entities Conduct the following in vitro ADME experiments logP, logD, pKa measurements CYP induction and inhibition assays Permeability determinations (Caco-2, MDCK etc) in relevant cell lines CYP phenotyping in purified enzyme systems Solubility determinations (kinetic, thermodynamic, simulated fluids) Bioanalysis : Read and understand the bioanalysis sections in the study protocols LC-MS/MS and HPLC-UV/PDA method development and validation (partial and complete) Developing fit-for-purpose LC-MS/MS methods for routine in vitro sample analysis Extracting data from the instrument, conducting bioanalytical QC and sharing of report with the stakeholders within the DMPK department Experience in handling bioanalytical method development for various matrices with focus on in vitro samples; understanding to handle plasma, blood, various tissues, urine, faeces etc. is a plus but not mandatory. Development LC-MS/MS methods for biochemical and cell based screening of NCEs is a plus but not mandatory General LC-MS/MS and HPLC maintenance and troubleshooting Data analysis and report generation: Understand the quality of bioanalytical data Conduct data analysis employing Phoenix WinNonLin software is a plus but not mandatory Ability to calculate in vitro results/ parameters on excel spreadsheets Report generation (excel format, word format and PowerPoint presentation) and sharing with the line manager Generate reports in both GLP and non-GLP formats (based on the requirement) Person Profile Qualification: - M.Sc /M.Tech (Biochemistry, Pharmaceutical Chemistry, Biotech background) Master in Pharmacy (M.Pharm) Experience: - 2- 6 years of relevant experience.

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years

2 - 2 Lacs

Hyderabad

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Walk-In - Trainee CRA(Males) - B.Pharm / M.Pharm Freshers - Vimta Labs Greetings from Vimta Labs Ltd! We have openings for Freshers (Males only) in Clinical Research at Vimta Labs. Details of the job: Qualification: B. Pharm / M. Pharm Experience: Freshers No. of Positions: B. Pharm (5), M. Pharm (5) Job Location : Vimta Labs, Cherlapally CTC: 2.24 to 2.51LPA Gender: Only Male as this includes Night Shifts as well. Interested candidates can directly walk in to our office. Walk-In Date: 13th May (Tuesday) - 15th May (Thursday) Time: 10 AM to 11AM Interview Venue: Vimta Labs Ltd, IDA Cherlapally, Hyderabad Telangana 500051 Contact: Keerthana 9160712930

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