8 Bioanalytical Jobs

Role & responsibilities Development and validation of bioanalytical methods using LCMS and other sophisticated instruments. Routine calibration of the instruments. Strong basic knowledge about Analytical instruments of LCMS, HPLC, HPTLC, GC-MS and other instruments. Good understanding of GLP and documents thereof. Knowledge of USFDA guidelines. Excellent communication skills & co-ordination among all the team members. Should possess good interpersonal and management skills Accountable for the whole group productivity in terms of number of samples, analysis, quality, quantity timelines better Turn Around Time (TAT) improvement Preferred candidate profile The candidate should have 1-3 years of experience in Bioanalytical Lab.

Roles and Responsibilities Develop new products by formulating, developing, and launching solid oral products. Conduct bioanalytical testing to ensure product quality and stability. Collaborate with cross-functional teams for process development, PDR (Process Development Research), MFR (Manufacturing Formulation Research), FD Trial (First Time Right Trial). Ensure compliance with regulatory requirements through documentation of SOPs, BPRs, and batch records. Provide technical support to production team on product-related issues.

Key Responsibilities 1. Dossier Preparation and Submission CTD/eCTD Compilation: Assemble and submit regulatory dossiers in Common Technical Document (CTD) format, including modules for clinical, non-clinical, and quality data.

BASIC SKILLS AND ABILITIES REQUIRED Demonstrate ability to pipette accurately. Knowledge of all basic of ELISA, instrumentation such as centrifuge, vortexer, shaker, Milli Q water system, Analytical Balance, freezer, refrigerator, water bath, volumetric flask, microplate washer, microplate reader and other lab related activities etc. Also demonstrate ability of handling biological samples, reagents as well as working/reference standards. MINIMUM EDUCATION, TRAINING AND EXPERIENCE REQUIRED A minimum of B.Sc or equivalent education unless demonstrated competence through work experience. SUPERVISED BY Project Manager SUPERVISES None. PRINCIPAL DUTIES AND RESPONSIBILITES Note: These statements reflect the general description of the position and are not intended to be an all-inclusive list of tasks to which the employee may be assigned. I RESPONSIBILITES A. Responsible as sample handling person for activities like recipient and storage of study samples, blank matrices and bulk spiked samples. Also will be responsible for labeling, retrieval, restorage, retention, shipment and disposal of study samples and bulk spiked samples as required and for the relevant documentation of sample handling activities. B. All activities related to reference standard, volumetric flask, analytical balance, centrifuge, vortexer, shaker, Milli Q water system, freezer, refrigerator, pipette, microplate washer, microplate reader etc. along with their maintenance record. C. To ensure the availability of first aid box and proper functioning of safety equipments in laboratory. D. Preparation of In-house ??Certificate of Analysis¢? for working/Reference standards. E. Issuance and recipient of Working/Reference standards. F. Maintenance of temperature monitoring devices. G. Maintain inventory of laboratory equipment spares. H. Assess and ensure adequate recourses are in place. I. Coordinate with lab personnel for smooth functioning of day to day lab activities. J. To supervise the glassware cleaning activity and laboratory store.

ORGANISATIONAL OVERVIEW Lambda Therapeutic Research is a full-service Global Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Pittsburgh (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. JOB DETAILS Department: Bioanalytical- Protiens & Biosimilars Designation: Research Associate Job Location: Ahmedabad (Gujarat) Education: M.Pharm/B.Pharm or M.Sc. Experience: 0 to 2 years CTC Range: 3 to 4 Lacs Key Responsibilities: Design and execute experiments to assess the PK and immunogenicity of therapeutic compounds using a variety of assays and methodologies. Develop and validate bioanalytical methods for the detection and quantification of anti-drug antibodies (ADA) and neutralizing antibodies (NAb). Collaborate with cross-functional teams to plan and conduct immunogenicity studies, ensuring compliance with regulatory guidelines. Analyze and interpret data, generate scientific reports, and present findings to internal teams and external stakeholders. Stay up-to-date with the latest advancements in immunogenicity bioanalysis and contribute to the development of innovative approaches. Maintain laboratory equipment, ensure data integrity, and adhere to quality control and safety protocols. Participate in regulatory submissions and assist in interactions with sponsor audits as needed. COMPETENCIES Communication Work Ethic Organizational Culture fit Accountability

The Position Organization : - Jubilant Biosys Designation & Level: - Research Associate/ Sr. Research Associate (A3/A4) Location: - Greater Noida Department: - DMPK Key Responsibilities In Vitro ADME studies Read and understand various in vitro ADME protocols Conduct in vitro stability (liver microsomes, plasma and in any other relevant matrix, chemical stability) experiments for new chemical entities Conduct the following in vitro ADME experiments logP, logD, pKa measurements CYP induction and inhibition assays Permeability determinations (Caco-2, MDCK etc) in relevant cell lines CYP phenotyping in purified enzyme systems Solubility determinations (kinetic, thermodynamic, simulated fluids) Bioanalysis : Read and understand the bioanalysis sections in the study protocols LC-MS/MS and HPLC-UV/PDA method development and validation (partial and complete) Developing fit-for-purpose LC-MS/MS methods for routine in vitro sample analysis Extracting data from the instrument, conducting bioanalytical QC and sharing of report with the stakeholders within the DMPK department Experience in handling bioanalytical method development for various matrices with focus on in vitro samples; understanding to handle plasma, blood, various tissues, urine, faeces etc. is a plus but not mandatory. Development LC-MS/MS methods for biochemical and cell based screening of NCEs is a plus but not mandatory General LC-MS/MS and HPLC maintenance and troubleshooting Data analysis and report generation: Understand the quality of bioanalytical data Conduct data analysis employing Phoenix WinNonLin software is a plus but not mandatory Ability to calculate in vitro results/ parameters on excel spreadsheets Report generation (excel format, word format and PowerPoint presentation) and sharing with the line manager Generate reports in both GLP and non-GLP formats (based on the requirement) Person Profile Qualification: - M.Sc /M.Tech (Biochemistry, Pharmaceutical Chemistry, Biotech background) Master in Pharmacy (M.Pharm) Experience: - 2- 6 years of relevant experience. Experience in a drug discovery industry/ CRO in DMPK department. Jubilant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, colour, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion or any other characteristic protected by applicable local laws, regulations and ordinances.

" The Position Organization : - Jubilant Biosys Designation Level: - Research Associate/ Sr. Research Associate (A3/A4) Location: - Greater Noida Department: - DMPK Key Responsibilities In Vitro ADME studies Read and understand various in vitro ADME protocols Conduct in vitro stability (liver microsomes, plasma and in any other relevant matrix, chemical stability) experiments for new chemical entities Conduct the following in vitro ADME experiments logP, logD, pKa measurements CYP induction and inhibition assays Permeability determinations (Caco-2, MDCK etc) in relevant cell lines CYP phenotyping in purified enzyme systems Solubility determinations (kinetic, thermodynamic, simulated fluids) Bioanalysis : Read and understand the bioanalysis sections in the study protocols LC-MS/MS and HPLC-UV/PDA method development and validation (partial and complete) Developing fit-for-purpose LC-MS/MS methods for routine in vitro sample analysis Extracting data from the instrument, conducting bioanalytical QC and sharing of report with the stakeholders within the DMPK department Experience in handling bioanalytical method development for various matrices with focus on in vitro samples; understanding to handle plasma, blood, various tissues, urine, faeces etc. is a plus but not mandatory. Development LC-MS/MS methods for biochemical and cell based screening of NCEs is a plus but not mandatory General LC-MS/MS and HPLC maintenance and troubleshooting Data analysis and report generation: Understand the quality of bioanalytical data Conduct data analysis employing Phoenix WinNonLin software is a plus but not mandatory Ability to calculate in vitro results/ parameters on excel spreadsheets Report generation (excel format, word format and PowerPoint presentation) and sharing with the line manager Generate reports in both GLP and non-GLP formats (based on the requirement) Person Profile Qualification: - M.Sc /M.Tech (Biochemistry, Pharmaceutical Chemistry, Biotech background) Master in Pharmacy (M.Pharm) Experience: - 2- 6 years of relevant experience.

Walk-In - Trainee CRA(Males) - B.Pharm / M.Pharm Freshers - Vimta Labs Greetings from Vimta Labs Ltd! We have openings for Freshers (Males only) in Clinical Research at Vimta Labs. Details of the job: Qualification: B. Pharm / M. Pharm Experience: Freshers No. of Positions: B. Pharm (5), M. Pharm (5) Job Location : Vimta Labs, Cherlapally CTC: 2.24 to 2.51LPA Gender: Only Male as this includes Night Shifts as well. Interested candidates can directly walk in to our office. Walk-In Date: 13th May (Tuesday) - 15th May (Thursday) Time: 10 AM to 11AM Interview Venue: Vimta Labs Ltd, IDA Cherlapally, Hyderabad Telangana 500051 Contact: Keerthana 9160712930