6 Large Molecule Jobs

Role & responsibilities: The candidate should be an expert in the area of drug product development. He/she should have high level of experience to be called a subject matter expert in concepts of product stability, role of excipients in protein stability, knowledge of higher order structure and its role on product stability The candidate should be well-versed on drug product formulation development. He/she should have knowledge on the concepts of developing a brand new formulation, evaluation of buffer systems, sugar excipients, role of surfactants such as polyols etc. Having experience of developing new formulations for Biosimilar products is a plus The candidate should have experience in running stability programs which include temperature, forced degradation studies, photo-stability studies etc. for multiple programs and should have demonstrated ability to trouble-shoot and course-correct as required in the development phase of Biosimilar drugs The candidate should have expert knowledge on product quality estimation techniques such as HPLC, CE-SDS etc that are connected to Drug Product development so that he/she should be able to understand the nuances of the data generated and relate it to the conclusions being made in formulation The candidate should have knowledge of particle characterization techniques such as DLS and should have experience in implementing such characterization techniques to drug product development. The candidate should have demonstrated experience in conducting studies for scale down model qualification and process characterization experiments associated with drug product. The candidate should be well-versed in basic statistics and should have experience in using statistical software such as JMP, Minitab etc. The candidate should have basic knowledge of regulatory guidance from USFDA, EMA etc. and should have knowledge of ensuring development is done to meet the regulatory requirement. The candidate should have years of experience in developing drug product related data for Biosimilars. The candidate should have mid-level knowledge of various container closure systems such as vials, pre-filled syringes, auto-injectors etc. that are prevalent in the market. Preferred candidate profile: Design studies for the development of drug products for conducting various types of stability studies including process characterization studies Handling of instrument calibration/maintenance issues, interfacing with Engineering and vendors for instrument maintenance so that lab is functioning smoothly Interpretation (including statistics) of data generated, preparing presentations for project meetings and presenting data to seniors Enable process development activities including filter validation, extractables and leachables Involvement in vendor selection, evaluation, legal and IPR documentation, EHS activities and any ad-hoc trainings as required by the Company; discussions with external consultants Ability to manage a team Educational Requirements: Masters in Biotechnology/Pharmacy/any other related field with 12 to 17 years of relevant industrial experience PhD in Biotechnology/Pharmacy/any other related field with 8 to 12 years of relevant industrial experience Post-doctoral research in relevant field with 2 to 3 years of relevant industrial experience

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.

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

#hiring. Know anyone who might be interested? Veeda Lifesciences (Veeda Clinical Research) is seeking a passionate "Characterization Specialist" Experience: with 3 to 6 yrs Location: Bangalore Interested candidates can share an updated CV to mahendra.t3705@veedalifesciences.com JOB DESCRIPTION: Role & responsibilities: Experiments Execution of planned experiments/studies using physico-chemical methods. Develop advanced LC-MS-based methodologies for the characterization of protein and peptide products. Design and implement integrated analytical strategies by combining chromatography and mass spectrometry techniques. These strategies aim to qualitatively and quantitatively assess product-related variants and impurities. This includes the development of innovative sample preparation methods, with a focus on LC-MS, CEX-MS, and SEC-MS, native MS, HDX as well as the characterization of innovator product batches sourced from various geographical regions to establish a comprehensive quality target profile. Lead the development of sophisticated analytical workflows, including multi-attribute methods for post-translational modifications (PTMs), sequence variant analysis, profiling of host cell proteins (HCPs), disulfide bond analysis and shuffling, cell culture metabolite analysis, and glycan profiling. Data Generation Sample preparation, data acquisition, data analysis/processing of HPLC/UPLC/LCMS/HRMS/CE based experiments/studies. Preferably on Thermo/Waters/Sciex platforms. Interpretations Scientific interpretations of processed data (manual/software-driven). Reporting Reporting of scientific data into suitable/approved report formats. Data Integrity Adherence to data integrity principles (ALOCA++) and quality compliance, as applicable. Documentation Preparation and up-keep of documents such as standard operating procedures, instrument/equipment related documents on qualification/validation, as applicable. Instrumentation Co-ordinate for maintaining the operational status of respective instrument/equipment with vendors/OEM. Ad-hoc Studies Execute ad-hoc studies/experiments/activities based on organizational needs/priorities. Knowledge Upskill with advancements in physico-chemical and/or structural characterization through literature surveys/webinars/conferences/symposiums. Conferences Participate in scientific meetings/interactions and present scientific data in form of posters/oral presentations/publications.

#hiring . Know anyone who might be interested? "Bengaluru Location" Veeda Lifesciences is seeking a passionate "SPR Specialist". Experience Required: 3 to 6 Years Education Required: B pharma and M pharma Drop your CV to: mahendra.t3705@veedalifesciences.com Role & responsibilities Surface Plasmon Resonance (SPR) based studies for Drug substances and Drug products that include therapeutic peptides, therapeutic monoclonal antibodies and other therapeutic large molecules. Design and execute project experiments. Demonstrate acceptable technical/scientific skills. Adequate knowledge in various immobilization chemistries. Analyze and report the observations and conclusions. Provide rationale or hypothesis for the observations and conclusions. Work in a regulated environment and record laboratory data as per the SOPs, standards and ALCOA++ principles. Prepare or review SOPs with guidance, as required. Participate in routine lab related activities. Develop new SPR capabilities. Experience in any of the following assays will be an added advantage. Cell based flow cytometry assays Flow cytometry based immunophenotyping Flowcytometry or multiplex based cytokine analysis ADCC, ADCP and CDC assays

He/She will be involved in day-to-day hands-on research activities related to large molecule drug discovery, antibody discovery, display technologies, multi specific immunofusions, ADCs, studies with both human & murine immune cells, tumor biology Required Candidate profile •experience in small and large molecular drug discovery •Hands-on experience in in vitro functional assays •solid foundation in molecular and cell biology