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10.0 - 16.0 years
10 - 15 Lacs
bengaluru
Work from Office
Role & responsibilities Ensure timely reporting of deviations, appropriate investigations to identify root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence. Perform the manufacturing investigations for OOS results and Customer Complaints to identify root cause or most probable root cause and facilitate proposal & implementation of appropriate CAPA to prevent reoccurrence. Participate in the audits and inspections as SME for deviation management and manufacturing investigations. Ensure timely proposal and implementation of appropriate CAPA for any audit findings. Perform timely tracking of Operational and Compliance Metrics for Manufa...
Posted 3 weeks ago
2.0 - 14.0 years
0 Lacs
karnataka
On-site
As an experienced individual with a background in M. Pharm (Pharmacology / Pharmaceutical Analysis) / M.Sc. (Biochemistry / Pharmaceutical Chemistry) with 11-14 years or Ph.D. with 2-5 years of relevant experience, you will be responsible for the following key roles and responsibilities: - Expertise in designing and executing DMPK studies to support antibody-drug conjugate (ADC) and monoclonal antibody (mAb) programs, covering the entire spectrum from discovery through IND-enabling stages. - Extensive experience in quantifying biologics such as antibodies, therapeutic proteins, ADCs, and peptides using platforms like LC-MS/MS, MSD, and ELISA. - Proficiency in utilizing advanced bioinformatic...
Posted 3 weeks ago
1.0 - 4.0 years
0 Lacs
bengaluru
Work from Office
Job description: Perform ELISA & MSD based analysis and record data. Support development and validation of bioanalytical methods as per guidelines/guidance and apply validated methods for the routine samples analysis. Perform assigned work independently or with minimum supervision. Candidate should work in GLP environment following SOPs and protocols without any deviation. Calibrate and maintain the laboratory equipment. Prepare method SOPs. Communicate effectively and professionally with peers, team members and other stakeholders Skills Required: Candidate should have some experience in ELISA & MSD techniques for large molecule bioanalysis and Immunogenicity. Candidate should have knowledge...
Posted 1 month ago
12.0 - 16.0 years
15 - 25 Lacs
bengaluru
Work from Office
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 r...
Posted 1 month ago
7.0 - 12.0 years
5 - 15 Lacs
Bengaluru
Work from Office
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, clo...
Posted 3 months ago
10.0 - 15.0 years
12 - 22 Lacs
Bengaluru
Work from Office
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 inte...
Posted 3 months ago
3.0 - 6.0 years
4 - 8 Lacs
Bengaluru
Work from Office
#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-relat...
Posted 3 months ago
3.0 - 6.0 years
0 - 1 Lacs
Bengaluru
Work from Office
#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 h...
Posted 4 months ago
1 - 6 years
6 - 14 Lacs
Vadodara
Work from Office
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
Posted 5 months ago
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