10 Bioassay Jobs

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.

Day to day analytical activities for robust method development for peptide molecules by different techniques (HPLC and GC).Preparation of Analytical Developments Validation Protocol, process scale-up,validation of methods.Interact with customes. Required Candidate profile PhD Chemistry with 7+ years of experience in Analytical R&D in Peptide analytical method development, peptide characterization. Worked on Biotechnology, Chemical peptides and proteins related science.

Dishman Group is looking for Trainee - API QC to join our dynamic team and embark on a rewarding career journey. Assisting experienced employees with their daily tasks and responsibilities Observing and gaining hands-on experience in various aspects of the job Receiving feedback and guidance from supervisors and mentors Completing assigned projects and tasks under the supervision of experienced employees Collaborating with team members and contributing to team projects Demonstrating a strong work ethic, positive attitude, and a willingness to learn and grow

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

Job Responsibilities: A) Project Management Undertake on-going referencing and literature reviews and provide strategic inputs to projects at all stages Evaluate methods under consideration by conducting literature survey (incl. regulatory guidelines, pharmacopeia guidelines, publicly available research, etc.) Identify initial cell-lines/ anti-body requirement based on method(s) identified Conduct lab experiments for bio-assay/ immuno-assay development and optimization Conduct lab experiments to qualify the method for reproducibility Prepare/provide inputs for the preparation of necessary documents like Method development report, Method qualification protocol and report. Method validation protocol and report, Standard Analytical Procedures (SAP), Method transfer protocol and report. Ensure tech-transfer by demonstrating process to plant operators (in lab premises) Observe process in plant and resolve any queries that may arise (post-transfer) B) Bio-assay/Impurity assay (HCP and HCDNA) /Binding ELISA assay/SPR assay/BET Method development, qualification and transfer Conduct regular analysis for non-GMP and non- release batches (not transferred to plant) - support other labs by stability testing samples provided by them Prepare and share detailed reports with the relevant labs upon completion of the tests Conduct Bioassay, HCP, HCDNA, Protein A ELISA, SPR, Binding assay and BET method development/qualification and routine analysis (C) Other tests and routine processes Conduct / guide RAs for conduct of regular analysis for non-GMP and non-release batches (not transferred to plant) - Support other labs by stability testing samples provided by them tests as requested. Prepare/review and share detailed reports with the relevant labs upon completion of the tests Conduct/ guide RAs for conduct of method development/qualification and routine analysis Review protocols and reports provided by CRO (based on expertise) Coordinate CRO with ADA assays, Antibody generation, purification and biotinylating activity for in-house HCP method. (D) Materials and equipment management Procure and maintain inventory of cell-lines/anti-bodies/ consumables/ equipment: Share details of requirements with purchase team Engage in technical discussions with vendors to identify and recommend suitable ones to lab head and Supply Chain Raise PR for purchase Oversee Check materials upon receipt and store them as per set-norms (freeze in case of cell-lines) Track and maintain inventory in order to control and manage short-falls and damage Maintain inventory-logs and intimate superiors in case of short-falls and damage Manage cell-culturing and sub-culturing process: Prepare cell-banks (by freezing cell-lines) for storage Passage cells (remove vials from these banks) as per testing need Calibrate select lab-equipment on regular basis to facilitate use Ensure scheduled and break-down maintenance by coordinating with vendors/ maintenance team ( E) Regulatory and compliance Accurately capture all lab experiments in raw- data and lab-notebooks (incl. electronic data- capture) in real-time on an on-going basis. Adhere to regulatory, SOPs and safety guidelines for all processes. Ensure timely closure of regulatory queries by conducting and documenting lab experiments. Ensure data integrity in all respects Compile and Review all project-related documents created during lab activity on a regular basis Prepare/ modify SOPs by gauging work ability of the processes/practices in timely manner (F ) Business (people & budgets) planning, continuity and improvement Conduct SOP and induction trainings for subordinates Provide timely and relevant inputs for the preparation of capex budget Identify and implement continuous improvement initiatives to enhance process efficiency Take initiative to provide time and inputs (based on expertise/interest) to other on-going projects (G) Learning and improvement Attend all mandatory trainings Take initiative to provide inputs (based on expertise/interest) to other on-going projects Take initiatives for self-development and update self on recent developments in own area of work Take initiative to train fresh RAs upon induction or guide them with select lab processes (basis expertise) (F) Quality Compliance Initiate change control for New instrument IQ/OQ/PQ/CSV of new instrument. GDP Compliance Compliance related to internal and external audits

About the Company Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. Six molecules from Biocon Biologics portfolio have been taken from lab to market in developed markets like United States, EU, Australia, Canada and Japan. With a team of ~ 4,800 people, Biocon Biologics is committed to transforming healthcare and transforming lives by enabling affordable access to millions of patients’ worldwide. Education : Masters Degree Experience : 2-4 Years Key Skills: Bioassay, Cell Culture, Molecular Biology, Pharma experience Primary Responsibilities 1. Ensure & Implementation of Data Integrity Culture in Quality Control Lab. 2. Adherence to cGMP (Current Good Manufacturing Practice), cGLP (Current Good Laboratory Practice) and GDP (Good Documentation Practice). 3. Qualification of Analytical instruments and Equipment (IQ/OQ/PQ) and Facility readiness. 4. Receipt of in process, DS, reserve samples and stability samples and storage at QC location. 5. Preparation, qualification and life cycle management of cell banks used in bioassays. 6. Planning and performing In-Process, finished product and stability sample testing of monoclonal antibodies and biosimilars and reporting the results. 7. Review of analytical reports of In process, finished product, stability, method validation, method transfer and study, Review of usage log books and Observation data sheets. 8. Preparation and review of method validation, method transfer, study protocol, Stability protocols and summary sheet (Compilation Data) and reports. 9. Planning and performing (Testing) of method transfer, method validation and study samples. 10. Verification of laboratory compliances, which include the validity checking of the reagents, standards, system status etc. 11. Reporting and investigation of Incidents, OOS, OOT and Deviation. 12. Supporting Operational Excellence, 5S in Quality control Lab. 13. Calibration of analytical weighing balance, pH meter etc. 14. Various monitoring such as lab and equipment and cleaning of labs activities 15. Performing stability related activity. Secondary responsibilities (Wherever applicable): 1. Cross functional coordination with all the inter departments for smooth flow of activities. 2. Supporting to other QC functions (QMS, inter sectional activities) when required. 3. Any activity assigned by supervisor/manager apart from the primary responsibilities.