11 Bioassay Jobs

Role & responsibilities Basic Biological Laboratory techniques. ELISA, Mammalian cell culture, HPLC, Flow cytometry. Molecular Biology Techniques. Documentation as per GLP. You can also share your CVs at pradnya.raut@accutestglobal.com for early call backs.

Location - Manufacturing Unit, Bommasandra Qualification - MSc - Chemistry Experience - 2- 5 yrs Role : Analyst LCMS/HRMS Key Job responsibilities: Analyst should able to carryout testing in method transfer and method verification activities. Subject matter expert on analysis of HPLC, LCMS, GCMS for both assay and impurities routine samples of in process, cleaning validation, SFG & Stability. Subject matter expert in analysis of nitrosamine impurities. Subject matter expert calibration of instrument and its management.

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

Core Purpose of the Role: Responsible to perform the development, validation, and routine testing of bioassay/ELISA for Large Molecules (LMs), especially Monoclonal antibodies (mAbs) and other LMs Role Accountabilities: Shall develop and validate cell-based assays and binding assays (ELISA), especially for monoclonal antibodies (mAbs), etc. Shall troubleshoot the problems with bioassay methods Must have strong knowledge of the development of cell-based bioassays for Monoclonal antibodies. Experience in Qualification and Validation of cell-based bioassays Broad knowledge on analysis of cell-based assays to derive relative potency softwares (such as Softmax Pro and PLA) Basic cell culture technics and hands-on experience in maintaining of mammalian cells. Must have experience in handling various cell lines (adherent and suspension cell lines). Preparation of Mammalian cell banks for Bioassays. Experience in handling of primary and continuous cell lines like Revival, maintenance, cell bank preparation, and cryopreservation Shall prepare the raw datasheets, protocols, reports, and SOPs Handling of QMS (Incidents, deviations, change controls, etc.) for GMP activities Shall be responsible for procurement and inventory maintenance of Pharmacopeial Standards/Chemicals/Reagents/Consumables/Spares etc., required for the projects Shall adhere to the procedure of GxP/GMP/Safety and as per the procedure defined in the internal standard operation procedure Must have good hold on MS office (word, excel, ppt), outlook, and other essential tools required for routine activity Good communication and e-mail writing skills are required since the candidate needs t communicate with clients/external users situated overseas Commitment to safety

Good knowledge and understanding of proteins. Sound knowledge on Good laboratory practices. Hands-on experience on LC based analysis/developments for recombinant protein (mAbs/Biosimilars) required Good team player. Good written and oral communication Role & responsibilities Should have sound knowledge of ICH/USP/EP/IP guidelines, including the writing and review of developmental protocols and reports. Will be part of ADL- The team works on- new method developments, qualifications, process development quality analysis, R&D stabilities Will carry out LC based developments for various quality evaluations of recombinant proteins (Example- RP, IEX, Glycans) Will carry out CE based developments for various quality evaluations Will carry out various analysis for supporting different process stages from clone selection to upstream and downstream process optimizations. Will be responsible for carrying out method qualifications and transfers either to manufacturing quality control or any outsourced labs Will plan/ carryout stability studies for R&D batches. Should be able to assess stability trends and draw conclusions Should be able to plan out experiments and activities for day-to-day functioning Will be responsible Co-ordinate with external labs for outsourced activities Maintenance of equipment logs and documentation in the lab. Will be responsible for routine experimental data compilations and reviews

Technical/functional skills: 1. Development, performance and troubleshooting of cell-based assays development, qualification and sample analysis for therapeutic protein, monoclonal antibodies. 2. Development, performance and troubleshooting of SPR, ELISA and flow cytometry assays for monoclonal antibodies. 3. Preparation of technical documents. 4. Writing of SOP, Protocol and Reports. Key responsibilities : 1. Cell based assays development, qualification and sample analysis for therapeutic proteins, monoclonal antibodies. 2. To take charge of the equipment/instruments in the lab and ensure their proper functioning. 3. To support and maintain inventory of reagents & consumables required for general lab activities.

Role & responsibilities Design, develop, and optimize ELISA assays of drug or other targets in complex biological matrices using Immunologic, Chromatographic or other methods. Align with the concepts of drug molecule and endogenous biomarker bioanalysis in support of pharmacokinetics, Pharmacodynamics and other purposes. Perform ELISA-based analysis on biological samples and interpret results. Ensure accuracy, precision, and reproducibility of assay results in accordance with established protocols and standard operating procedures (SOPs). Troubleshoot, validate, and optimize assays to improve sensitivity, specificity, and throughput. Work closely along with team members to understand their requirements, provide technical support, and deliver high-quality data in a timely manner. Prepare and maintain accurate laboratory records, including experimental design, methodologies, data analysis, and reports. Adhere to all safety guidelines and regulatory compliance requirements (e.g., GLP, GCP). Stay up to date with current trends in immunoassay technologies and applications. Education: A Bachelors or Masters degree in Immunology, Biochemistry, Molecular Biology, or a related field. A Ph.D. is a plus. Experience: Minimum of 5 years of hands-on experience in ELISA assay development and execution in a laboratory setting, preferably in a CRO or similar industry. Experience in performing various types of ELISA, including sandwich, competitive, and indirect assays. Knowledge of other immunoassay techniques (e.g., Western blot, flow cytometry) is a plus. Skills: Strong understanding of immunology and biochemistry principles. Proficiency in laboratory techniques, instrumentation, and data analysis. Experience with data management software and laboratory information management systems (LIMS). Strong problem-solving and troubleshooting skills. Excellent attention to detail and organizational skills. Ability to work effectively both independently and as part of a team. Excellent written and verbal communication skills. Preferred Skills: Familiarity with regulatory guidelines (e.g., GLP, GMP). Experience in assay validation, qualification, and report writing. Prior experience in CRO or contract research environments is highly desirable. Preferred candidate profile: can send updated resume to email: hr@qpsbioserve.com.

Good knowledge and understanding of proteins. Sound knowledge on Good laboratory practices. Hands-on experience on LC based analysis/developments for recombinant protein (mAbs/Biosimilars) required Should have sound knowledge of ICH/USP/EP/IP guidelines, including the writing and review of developmental protocols and reports. Will be part of ADL- The team works on- new method developments, qualifications, process development quality analysis, R&D stabilities Will carry out LC based developments for various quality evaluations of recombinant proteins (Example- RP, IEX, Glycans) Will carry out CE based developments for various quality evaluations Will carry out various analysis for supporting different process stages from clone selection to upstream and downstream process optimizations. Will be responsible for carrying out method qualifications and transfers either to manufacturing quality control or any outsourced labs Will plan/ carryout stability studies for R&D batches. Should be able to assess stability trends and draw conclusions Should be able to plan out experiments and activities for day-to-day functioning Will be responsible Co-ordinate with external labs for outsourced activities Maintenance of equipment logs and documentation in the lab. Will be responsible for routine experimental data compilations and reviews

Role & responsibilities Responsible for performing and overseeing ELISA (Enzyme-Linked Immunosorbent Assay) testing, ensuring high standards of accuracy, quality control, and efficiency in laboratory operations. This role involves leading a team of technicians, optimizing assay protocols, managing lab inventories, and analyzing data. Deliver GLP and non-GLP ELISA/LBA, MSD ECL, and Luminex Multiplex Analysis for Pharmacokinetic (PK), Toxicology (Tox), Biomarker, Bioavailability (BA), Biosimilar, Immunogenicity, and other bioanalytical studies. Complete Method Development or Method Transfer of customized, robust, and highly sensitive Chromatographic Assay using necessary sample preparation Develop, validate, and optimize ELISA protocols and procedures to improve lab performance and efficiency. Conduct and supervise ELISA testing for various research, diagnostic, and quality control purposes. Analyze data generated from ELISA experiments, including quantification of analytes and assessing assay performance. Analyze and interpret test results, ensuring proper documentation and reporting of data. Well versed in Operation and Calibration of ELISA Instrument with advancements in ELISA technology and laboratory best practices. Manage Incidents, deviation and investigations of ELISA results with documentation. Prepare and review of SOPs, work instructions, method development and method validation protocols and reports. Ensure compliance with safety and quality standards, including SOPs (Standard Operating Procedures) and regulatory requirements. Client management, including acting as company representative to help existing and potential clients, and serving as operational lead in client visits, facility and pre-qualification audits. Supervise junior and senior scientific staff, including evaluating performance and ensuring that all bioanalytical service activities are performed in a safe manner and according to SOPs and GLP regulations. Train, mentor, and provide technical support to junior lab staff and technicians. Work with cross-functional teams to support ongoing research or clinical studies. Preferred candidate profile Bachelor's or Master's degree in Biology, Biochemistry, Biotechnology, or a related field (PhD preferred). Minimum of 8-10 years of experience working with ELISA assays, including advanced experience in assay development and troubleshooting. Ph.D. plus 8 years relevant industry experience or 6 years CRO experience Master's Degree plus 13 years relevant industry experience or 9 years CRO experience Bachelor's Degree plus 14 years relevant industry experience or 12 years CRO experience Interested and suitable applicants can mail their updated CV to hr@qpsbioserve.com

Role & responsibilities Design, develop, and optimize ELISA assays of drug or other targets in complex biological matrices using Immunologic, Chromatographic or other methods. Align with the concepts of drug molecule and endogenous biomarker bioanalysis in support of pharmacokinetics, Pharmacodynamics and other purposes. Perform ELISA-based analysis on biological samples and interpret results. Ensure accuracy, precision, and reproducibility of assay results in accordance with established protocols and standard operating procedures (SOPs). Troubleshoot, validate, and optimize assays to improve sensitivity, specificity, and throughput. Work closely along with team members to understand their requirements, provide technical support, and deliver high-quality data in a timely manner. Prepare and maintain accurate laboratory records, including experimental design, methodologies, data analysis, and reports. Adhere to all safety guidelines and regulatory compliance requirements (e.g., GLP, GCP). Stay up to date with current trends in immunoassay technologies and applications. Education: A Bachelors or Masters degree in Immunology, Biochemistry, Molecular Biology, or a related field. A Ph.D. is a plus. Experience: Minimum of 5 years of hands-on experience in ELISA assay development and execution in a laboratory setting, preferably in a CRO or similar industry. Experience in performing various types of ELISA, including sandwich, competitive, and indirect assays. Knowledge of other immunoassay techniques (e.g., Western blot, flow cytometry) is a plus. Skills: Strong understanding of immunology and biochemistry principles. Proficiency in laboratory techniques, instrumentation, and data analysis. Experience with data management software and laboratory information management systems (LIMS). Strong problem-solving and troubleshooting skills. Excellent attention to detail and organizational skills. Ability to work effectively both independently and as part of a team. Excellent written and verbal communication skills. Preferred Skills: Familiarity with regulatory guidelines (e.g., GLP, GMP). Experience in assay validation, qualification, and report writing. Prior experience in CRO or contract research environments is highly desirable. Preferred candidate profile: can send updated resume to email: hr@qpsbioserve.com.

Roles & Responsibility: Perform method development, method validation and study sample analysis under supervision of Project Manager (s). Passaging of cells as well as performing cell based assays while maintaining aseptic conditions in cell culture laboratory. Perform ELISA & other Ligand Binding Assay according to study protocol guidelines and/or SOPs Processing of specimens to support the clinical studies. Preparation of required reagents and solvents. Preparation of SOP(s) and work instruction. Following GLP, GDP, GCLP & other good practices. Desirable candidate: MSc BioTech/ Biochemistry/ Microbiology or BTech Biotech fresher. 0-1 year of relevant experience will be preferable. Sound knowledge on Immunology. Good communication skills, analytical skills and team coordination.