11 Assay Development Jobs

You should hold an M.Sc degree with 2-4 years of experience in the pharmaceutical industry. Your responsibilities will include handling in vitro assays, both Biochemical and Cell-based assays. You should be skilled in assay development, validation, and screening. Proficiency in analyzing data using software like graphpad or xlfit is essential, along with the ability for independent interpretation of data. While not mandatory, experience in establishing and analyzing Immunological assays via Flow cytometry would be advantageous.,

Role & responsibilities Literature Survey for the assigned project. Analytical method development such as Assay, Dissolution, Related Substances method by HPLC. Analytical method validation of Assay, Dissolution, Related Substances method by HPLC as per ICH guideline by HPLC. 4. Analysis of Initial and stability samples. 5. Carry out basic trouble shooting for instrument related issues, whenever required. Email id- namita.raul@ashishlifescience.com

Role Skills & Competencies Strong conceptual and technical expertise in drug discovery with proven track record through clinical candidates nominations, IND filings, publications, patents and presentations at symposia. Therapeutic area experience in Oncology and target validation using CRISPR, PROTACS , RIPTACS, ADCs and payloads Technical experience in cell based mechanistic and functional assays and using automation for high throughput assays. Strong knowledge and hands on experience with CRISPR based approaches for knock out and knock in is a must. Excellent verbal/written communication skills; communicates in a clear, well-structured and professional manner with key stakeholders on a regular basis Experience in managing larger teams (>20 people) and/or departments (including management of resource and budget with the ability to work closely with support functions such as HR, finance, quality/regulatory and facilities) Ability to manage multiple discovery projects and responsibilities at the same time. Experience in managing project teams regarding quality, timelines and cost. Effectively applies and enables state-of-the-art technologies and best practices to improve operational efficiency. Excellent attention to experimental details, data quality, documentation with strong work ethics Acts as a subject matter expert and mentor, providing scientific expertise to the collaboration and across disciplines & responsibilities Preferred candidate profile - Mandatory to have - Assay Biology (Crispr gene editing, shRNA, lentiviral transductions, viability assays, proliferation assays, molecular biology, QPCR, Western blotting, Flow cytometry, Mammalian cell culture, 3D cell culture, experience in IPSC and organoids is a plus). PHD with 10+ years and exp in managing team Educational Qualification PhD in Cell Biology/Biochemistry/ Biotechnology with Post doctoral experience and >10 years of relevant industry (CRO, Pharma or Biotech) experience in Assay Biology and screening platforms. Proven track record preferably in a contract research environment would be desirable.

Job Title : Study Director - Pharmacokinetics and Immunogenicity Assays Job Location: Bangalore Department: Immunogenicity Research Laboratory - Translational & Clinical Research Job Purpose: The position holder is responsible for performing bioanalysis which includes performing ligand binding assays related to Pharmacokinetics and Immunogenicity. Key Responsibilities: Ensure activities conducted in the bioanalytical lab are in compliance with established SOPs, procedures, systems, regulatory guidance without deviating from established procedures. Regular interaction and participation with Study director, Quality Control (QC) and Quality Assurance (QA) during raw data and reports review, closure of observations and archival. Will be involved in strategic planning for project execution, documentation of data, data analysis, interpretation and presentation of the results • Ensure to complete the assigned tasks in timely manner. Actively involved in preparation of SOPs, protocols, method and reports Prepare reagents, buffers and maintain log book for assigned assays Interpret results - anticipate and understand the issues related to the assay. Participate in, and present data for discussions. Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety. Attend training on environment, health, and safety (EHS) measures imparted company Educational Qualification: Master's degree or Ph.D in Biological Sciences (Preferably Biochemistry background) or a related field Technical/functional Skills: Should have a strong background in immunoassay and bioanalytical Pharmacokinetics and Immunogenicity Assays with a good understanding as per regulatory guidance/ industry practices/internal Standard Operating Protocols. Should have hands-on experience in Ligand Binding Assay (LBA) development, validation and Sample analysis. Knowledge of ELISA and MSD assays are highly desirable. Knowledge and experience with regulatory requirements e.g. Organization for Economic Co-operation and Development (OECD), GXP, 21 CFR Part 11, European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines. • Manuscript writing ability is preferable Proficiency in software like Laboratory Information Management System (LIMS), GraphPad, Adobe etc. Experience: 7+ years of experience in immunoassay laboratory. (CRO experience is preferable). Behavioral Skills: Ability to work independently as well as with team members A strong proactive and independent thinker • Excellent communication skills - written and oral in English Should have good interpersonal skills Large degree of flexibility and ability to work under strong time pressure Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Qualifications and education requirement The prospective candidate should be a PhD/Post Doc in Biochemistry with a minimum of 5-8 years of research in academia or industry. Should have experience in enzyme characterization, enzyme kinetics and enzymatic conversions Roles and responsibilities Identification and development of processes for the purification of proteins/ enzymes from bacterial and / or yeast expression systems Development of strategies for maximizing the protein yield by solubilization of IB and refolding • Complete characterization of enzymes like activity, specific activity, pH optima, temperature optima, substrate loading, inhibition studies etc Determination of kinetic parameters Km, Vmax, rate of reaction etc Development of assays for different enzymes and optimization of analysis protocols Process development for production of different products using purified enzymes Identification of matrices for enzyme immobilization with reduced activity loss Perform operational stability studies of enzymes at different temperatures Development of lab scale process for packed bed conversion Essential attributes • Ability to work and liaison with multi functional teams • Acumen for leading and guiding peers and subordinates • Prior experience in carbohydrates would be desired • Passion for doing science and creating value

Design, develop PCR-based mol diagnostic assays Design, optimize primers, probes with high specificity, efficiency. Perform, troubleshoot assay optimization, thermal cycling conditions, reagent concentrations, multiplexing. DNA, RNA extraction Required Candidate profile Hands-on experience in PCR assay development Proficient in using primer/probe design tools, PCR platforms (ABI, Bio-Rad, Thermo, Qiagen) Expertise in Nucleic acid extraction methods, Quality Control

Role & responsibilities In the current role, the candidate will have to develop new cell therapy products and perform validations to take the product to the next stage. Extensive experience working with different types of immune cells and deep understanding of both innate and adaptive immune systems will be required. Previous experience in gene and/or cell therapy drug development teams will be preferred. Experience in design and delivery of genes using viral or non-viral transfer techniques. Design and construct of viral vectors using state-of-the-art molecular synthesis and cloning techniques. Experience in use of CRISPR/Cas9 or TALEN or other gene-editing tools Well-versed with different molecular biology techniques like cloning, sub-cloning, real-time and quantitative PCR, etc. Ability to multitask and contribute to multiple projects under demanding timelines while preserving integrity, accuracy, safety, and quality. The candidate should be proficient in verbal, written and presentation skills and previous experience in writing grants and research articles will be preferred. The candidate should have had experience in managing a team or working in a cross-functional group and interacting with clients/collaborators. The candidate needs to have leadership skills to gear a team towards excellence. Manage day to day activity of team members providing critical technical/scientific recommendations with effective trouble-shooting and innovative capabilities. The candidate should be able to effectively communicate and work closely in a highly matrixed team environment to advance companys cell therapy pipeline. The candidate will be expected to understand systems and processes pertaining to sterile practices, work ethics, safety, health, and environment. The candidate will have to be involved in preparation and participation during compliance monitoring inspections and regulatory agency interactions. The candidate must be involved in preparation and review of protocols, reports, regulatory documents, pertaining to program requirement. Competencies: Gene editing and molecular biology techniques Gene transfer Viral and non-viral methods for cell line generation Immunology/Immuno-oncology Genetics and Assays Preferred candidate profile Ph.D. (specialization in genetics and epigenetics related to Immunology/Immuno-oncology) with 1-2 years of experience in Gene Editing and Immuno-oncology and/or industry or M.Sc/M.Tech in Biotechnology with 8-9 years of experience in academia and/or industry

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

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Research Scientist Gene Therapy Job Requisitions No : 13325 Job Description Skill Required Candidate must have thorough understanding of cell and molecular biology along with several analytical techniques such as Flow Cytometry, PCR/qPCR, ELISA, etc Hands on experience in multicolor flow cytometry is indispensable for this position, Candidate should have good hands-on experience with aseptic handling, microbial and mammalian cell culture techniques, Candidate should have understanding of good documentation practices, preparation of SOPs, analytical reports, etc Understanding of regulatory guidelines with respect to analytical assay development and qualification will be an added advantage, Purpose of Job An experienced candidate (m-sc /m-tech in Biotechnology/biochemistry or other biological sciences with 5 to 6 years of relevant industry experience or Ph D fresher or with ~1 year of experience) for Cell and Gene Therapy Department, Cell Therapy Analytical Group at Intas Pharmaceuticals (Biopharma Division), Ahmedabad, Gujarat, India, Roles and Responsibilites Develop analytical methods (Flow Cytometry, qPCR, ELISA, Cell based assay (e-g In vitro cytotoxicity assay),) for Cell and Gene Therapy based products, Qualify analytical methods as per the regulatory guidelines, Provide support for analysis of in-process, DS and DP samples, Documentation in LNB, preparation of SOPs, Analytical Reports, etc Participate in method transfers to QC labs, AMC and CMC of instruments/equipment in analytical development lab, inventory management, etc Qualification Required Sc Competencies Intas Action Oriented Intas Customer Focus Intas Dealing with Ambiguity Intas Problem Solving Intas Time Management Relevant Skills / Industry Experience Flowcytometry, PCR/qPCR, ELISA, Cell based assay, etc Relevant professional / Educational background Sc Any Other Requirements (If Any) None Compensation / Reward As per HR policy Location: Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 11 Apr 2025

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Research Scientist Gene Therapy Job Requisitions No : 13322 Job Description Purpose of Job An experienced candidate (m-sc /m-tech in Biotechnology/biochemistry or other biological sciences with 5 to 6 years of relevant industry experience or Ph D fresher or with ~1 year of experience) for Cell and Gene Therapy Department, Cell Therapy Analytical Group at Intas Pharmaceuticals (Biopharma Division), Ahmedabad, Gujarat, India, Skill Required Candidate must have thorough understanding of cell and molecular biology along with several analytical techniques such as, PCR/qPCR, Flow Cytometry, ELISA, etc Hands on experience in qPCR is indispensable for this position, Candidate should have good hands-on experience with aseptic handling, microbial and mammalian cell culture techniques, Candidate should have understanding of good documentation practices, preparation of SOPs, analytical reports, etc Understanding of regulatory guidelines with respect to analytical assay development and qualification will be an added advantage, Roles and Responsibilites Develop analytical methods (qPCR, Flow Cytometry, ELISA, Cell based assay (e-g In vitro cytotoxicity assay),) for Cell and Gene Therapy based products, Qualify analytical methods as per the regulatory guidelines, Provide support for analysis of in-process, DS and DP samples, Documentation in LNB, preparation of SOPs, Analytical Reports, etc Participate in method transfers to QC labs, AMC and CMC of instruments/equipment in analytical development lab, inventory management, etc Qualification Required Sc Competencies Intas Action Oriented Intas Customer Focus Intas Dealing with Ambiguity Intas Problem Solving Intas Time Management Relevant Skills / Industry Experience PCR/qPCR, Flow Cytometry, ELISA, cell based assay, etc Relevant professional / Educational background Sc Any Other Requirements (If Any) None, Compensation / Reward As per HR Policy, Location: Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 11 Apr 2025

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.