39 Bioanalytical Jobs - Page 2

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

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

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

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

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.

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.

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.

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.

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

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.

" 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.

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

Role & responsibilities Perform Bioanalytical method developments, method validations & study sample analysis. Operation and maintenance of LC-MS/MS instruments. Preparation of SOPs & archiving the data.

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 Operations Designation: Research Associate Job Location: Ahmedabad (Gujarat) Education: M.Pharm/B.Pharm or M.Sc. Experience: 2 to 3 years CTC Range: 4 to 5 Lacs Job Description: To develop and validate Bioanalytical methods. To process / analyze samples of allotted projects. To operate, calibrate and troubleshooting of LC-MS/MS instruments and other analytical instruments. Preparation of draft and method SOP and to work in-compliance to System/Method Specific SOPs and relevant Plan/Protocol. To ensure training of all required SOPs/documents prior to initiating any related activities. To ensure effective implementation of GLP and 21CFR Part 11 by checking of instrument labels, completeness of logbooks of equipment s and instruments and ensuring the instrument calibrations are done before due date. Work as per OECD GLP principles