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3.0 - 8.0 years
3 - 6 Lacs
sanand
Work from Office
Responsibilities: * Conduct HPLC & GC analyses with accuracy * Ensure method validation meets standards * Develop testing processes using SOPs * Collaborate on quality control initiatives * Manage analytical instruments effectively
Posted 18 hours ago
4.0 - 7.0 years
3 - 6 Lacs
hyderabad
Work from Office
Role & responsibilities Develop, optimize, and validate analytical methods (HPLC, UPLC, GC, LC-MS, dissolution, etc.) for oncology drug substances and drug products. Perform characterization, stability testing, and release testing of clinical and commercial oncology formulations. Prepare analytical documentation including method validation protocols, reports, SOPs, and regulatory submission documents as per ICH and FDA/EMA guidelines. Support formulation development teams by providing analytical insights for process development, scale-up, and tech transfer activities. Conduct forced degradation and impurity profiling studies for oncology drug candidates. Ensure all analytical work is compliant with GLP/GMP and applicable regulatory requirements. Troubleshoot analytical challenges and provide technical guidance to junior team members. Interface with QA, Regulatory Affairs, Formulation Development, and Manufacturing teams to ensure seamless project execution.
Posted 19 hours ago
2.0 - 7.0 years
3 - 6 Lacs
hyderabad
Work from Office
Role & responsibilities Perform quality control testing of oncology products (raw materials, intermediates, and finished products) using validated analytical methods. Operate and maintain analytical instruments such as HPLC, GC, UV-Vis spectrophotometer, Dissolution Apparatus, FTIR, and other relevant equipment. Conduct stability testing as per ICH guidelines and prepare stability reports. Review and document analytical results in compliance with GDP and cGMP requirements. Identify and investigate deviations, OOS (Out of Specification) and OOT (Out of Trend) results, and implement corrective and preventive actions (CAPA). Support method validation, method transfer, and analytical troubleshooting. Ensure adherence to EHS (Environment, Health, and Safety) policies during laboratory operations. Maintain proper documentation, records, and ensure audit readiness for regulatory inspections (USFDA, MHRA, WHO, etc.). Collaborate with cross-functional teams to resolve quality issues and improve processes.
Posted 19 hours ago
2.0 - 7.0 years
2 - 6 Lacs
hyderabad
Work from Office
Role & responsibilities Develop, optimize, and validate analytical methods (HPLC, UPLC, GC, LC-MS, dissolution, etc.) for oncology drug substances and drug products. Perform characterization, stability testing, and release testing of clinical and commercial oncology formulations. Prepare analytical documentation including method validation protocols, reports, SOPs, and regulatory submission documents as per ICH and FDA/EMA guidelines. Support formulation development teams by providing analytical insights for process development, scale-up, and tech transfer activities. Conduct forced degradation and impurity profiling studies for oncology drug candidates. Ensure all analytical work is compliant with GLP/GMP and applicable regulatory requirements. Troubleshoot analytical challenges and provide technical guidance to junior team members. Interface with QA, Regulatory Affairs, Formulation Development, and Manufacturing teams to ensure seamless project execution.
Posted 19 hours ago
3.0 - 8.0 years
2 - 5 Lacs
hyderabad
Work from Office
Role & responsibilities Perform quality control testing of oncology products (raw materials, intermediates, and finished products) using validated analytical methods. Operate and maintain analytical instruments such as HPLC, GC, UV-Vis spectrophotometer, Dissolution Apparatus, FTIR, and other relevant equipment. Conduct stability testing as per ICH guidelines and prepare stability reports. Review and document analytical results in compliance with GDP and cGMP requirements. Identify and investigate deviations, OOS (Out of Specification) and OOT (Out of Trend) results, and implement corrective and preventive actions (CAPA). Support method validation, method transfer, and analytical troubleshooting. Ensure adherence to EHS (Environment, Health, and Safety) policies during laboratory operations. Maintain proper documentation, records, and ensure audit readiness for regulatory inspections (USFDA, MHRA, WHO, etc.). Collaborate with cross-functional teams to resolve quality issues and improve processes.
Posted 19 hours ago
0.0 years
17 - 22 Lacs
bengaluru
Work from Office
Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies. Job description: Planning/performing and reporting of acute toxicology studies Assist in preparation of SOP"™s, Protocols and Reports Participate in GLP / AAALAC related activities Literature search Maintenance of animal house and relevant documents as per GLP and AAALAC norms. To Assist and work along with SD and TC in Planning, initiation and conduct studies. Test item administration, dose formulation preparation and blood collection. Assistance in data collection, compilation and verification. Participate in GLP inspections and ensure relevant regulatory compliance guidelines. Support in interpretation and reporting of study data. Assist in report preparation and coordination of activities. Assist in archiving of all study related materials. Skills Required: Understanding of the agrochemical and pharmaceutical R&D process Behavioral Competencies: Good in oral / written communication skills. If you're interested in applying or learning more, send your updated resume to [email protected] with the subject line "Research Scientist/Senior Research Scientist - Acute "“ Toxicology - Bangalore". Qualifications Qualification M.Sc. in Zoology/Biosciences Additional Information Specialization Toxicology Department Acute "“ Toxicology Experience (years) 2 to 8 only
Posted 1 day ago
16.0 - 18.0 years
18 - 25 Lacs
bengaluru
Work from Office
Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies. Job description: Leadership role to manage team size of 10+ scientists (Ph.D. and M.Sc.) Extensive knowledge in E&L Extractable and Leachable experience in CCS as per USP monograph and medical devices as per ISO guidelines Managing multiple instruments (LC-MSMS, GC-MSMS, ICP-MS, IC etc.) Method development experience in LC-MSMS, GC-MSMS and ICPMS instrument Preparation and Implementation of SOP"™s related to E& L , general laboratory processes and best guidance. Good knowledge of 21 CFR part 11, Data Integrity principals, good documentation practices in cGMP lab Monitor and management of day-to-day laboratory activities Extensive knowledge of preparation, reviewing and approval capability for standard operating procedure (SOP) and COA Sound knowledge of structural elucidation and interpretation using analytical techniques such as NMR, IR, HPLC, GC, LC-MS etc. Resolving the team conflicts and provide training to the team for development and empowers team members Provide scientific and leadership direction to team members Good knowledge of laboratory safety and be a strong promoter of SHE activities in the lab. Skills Required: For M.Sc, 16-18 years of Discovery Analytical R&D experience and for PhD, 14-16 years of experience in CRO environment Excellent technical, problem-solving, writing, influencing and communication skills Strong leadership with excellent interpersonal skills, proven success of analytical projects and managing cross functional teams Demonstrative communication skills and confident in conveying information to internal/ external customers Skill for resolving the team conflicts and provide training to the team for development and empowers team members Behavioral Competencies: Excellent oral / written communication skills and flexibility to work in a dynamic environment Excellent in Knowledge sharing at all levels Qualifications Qualification M.Sc./PhD/Postdoc Additional Information Specialization Analytical Chemistry /Organic Chemistry, Department E&L Experience (years) 16 - 20
Posted 1 day ago
0.0 years
11 - 15 Lacs
hyderabad
Work from Office
Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies. : Medicinal chemistry; Research and development; Literature search; Scifinder / Reaxys; Design and synthesis; combiflash/Biotage; C-C coupling etc Qualifications MSC - Organic Chemistry.
Posted 1 day ago
5.0 - 10.0 years
7 - 13 Lacs
chandrapur
Work from Office
Responsibilities: Manage and oversee environmental testing operations as per ISO/IEC 17025 standards. Expertise in GC-MS instrument handling, method development, calibration, and validation. Coordinate NABL audits, quality documentation, and compliance with statutory guidelines. Lead technical staff, train analysts, and ensure adherence to SOPs. Prepare technical reports, client deliverables, and liaise with regulatory bodies. Desired profile of the candidate: Strong expertise in environmental parameter testing using GC-MS. Knowledge of NABL accreditation processes and ISO 17025 compliance. Proven leadership and technical management skills. Ability to train, supervise, and mentor junior analysts. Excellent documentation, communication, and problem-solving skills. (GC-MS Specialist, ISO 17025) Best in Industry Salary.
Posted 1 day ago
1.0 - 4.0 years
2 - 5 Lacs
mumbai
Work from Office
We are looking for a highly skilled and experienced Analyst-QC to join our team at eClerx Services Ltd. The ideal candidate will have a strong background in IT Services & Consulting, with excellent analytical and quality control skills. Roles and Responsibility Collaborate with cross-functional teams to identify and prioritize testing requirements. Develop and implement comprehensive test plans and cases to ensure high-quality deliverables. Conduct thorough analysis of test results and identify areas for improvement. Work closely with the development team to resolve defects and enhance overall product quality. Participate in continuous improvement initiatives to optimize testing processes. Maintain accurate records of test cases, results, and defect reports. Job Requirements Strong understanding of software testing principles, methodologies, and tools. Excellent analytical, problem-solving, and communication skills. Ability to work effectively in a fast-paced environment and meet deadlines. Experience with quality control processes and procedures. Familiarity with industry standards and best practices for software testing. Strong attention to detail and ability to identify defects and errors.
Posted 1 day ago
1.0 - 6.0 years
1 - 5 Lacs
bharuch, dahej, ankleshwar
Work from Office
Urgent opening for QC Officer-Sr. Officer in Dahej, Bharuch. Note: Walk In Interview at Bharuch Date & Time: 24th August, 2025 at 09:00 AM Onwards Job Location: Dahej, Bharuch Experience: 2 to 7 years in API Qualification: M.Sc./B.Pharm/M. Pharm Required Candidate profile Roles and Responsibilities: -Experience in Section LCMS / PSD / HPLC / GC /Method Validation -Candidate preferred from Pharma API (Active Pharmaceutical Ingredient).
Posted 1 day ago
2.0 - 4.0 years
2 - 3 Lacs
vellore
Work from Office
Responsibilities : To operate various high end instruments. To keep record on instrument usage. To maintain the SOP of the instruments. Keeps equipment operating by following operating instructions; troubleshooting breakdowns; maintaining supplies; performing preventive maintenance; calling for repairs. Resolves problems by examining and evaluating data; selecting corrective steps. Enhances laboratory and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments. Key Skills Handling sophisticated analytical equipment like Atomic Absorption Spectrophotometer, FT-IR, Raman, and Gas chromatograph for 2-4 years in a private or public laboratory. Extensive sample analysis experience is preferred. Sample analysis; troubleshooting; regular maintenance, and calibration of sophisticated analytical equipment. Educational Qualification MSc in Analytical Chemistry/Analytical Instrumentation
Posted 1 day ago
2.0 - 5.0 years
4 - 8 Lacs
noida
Work from Office
Job Track Description: Performs tasks based on established procedures. Uses data organizing and coordination skills to perform business support or technical work. Requires vocational training, certifications, licensures, or equivalent experience. General Profile Requires limited prior training or licenses and training certifications. Has basic operational or analytical skills to perform tasks. Works within clearly defined standard operating procedures and adheres to quality guidelines. Work is completed with close supervision and under clearly defined procedures. Functional Knowledge Requires a basic understanding of theories, practices, and procedures. Business Expertise Understanding of how best teams integrate and work together to achieve company goals. Impact Responsible for the accuracy of own work. Receives close supervision and duties are clearly defined. Methods and tasks are described in detail. Leadership Has no supervisory responsibilities. Problem Solving Uses existing procedures to solve standard problems. Has limited opportunity to exercise discretion. Interpersonal Skills Exchanges information and ideas effectively. Responsibility Statements Maintains employee records through data entry. Performs calculations for outstanding payments due on termination or leave of absence. Coordinates termination details to ensure assets are returned/access is revoked on the employee\u2019s last day. Compiles data for review and reporting. May perform routine analysis for internal review. Performs other duties as assigned. Complies with all policies and standards.
Posted 1 day ago
2.0 - 7.0 years
3 - 6 Lacs
hyderabad
Work from Office
Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation AR&D Department . Job Openings: 4 Nos Position : Research Analyst or Sr Research Analyst Experience : 2 - 7 Yrs Job Description: Responsible for Analytical Method Development activities solid orals and injectables Responsible for Responsible for Planning and Monitoring of Method development activities and Regular Analysis for solid orals and Injectables. Responsible for Routine and Stability analysis activities for solid orals and injectables. Responsible for the Review of documents generated in Method development activity. Responsible for the Preparation and Review of Tentative method of analysis and Method development Reports. Responsible for the review of Routine samples documents, Preformulations documents for the Solid oral products and Parental products. Responsible for the Review of Calibrations documents (i.e Dissolution, HPLC, UV and balance). Knowledge on ICH guidelines and all Regulatory guidelines Ref to Friends or colleagues Please share resume: careers@biophore.com Total Exp: Current CTC: Exp CTC: Notice Period: Designation:
Posted 1 day ago
4.0 - 6.0 years
0 - 0 Lacs
thane, navi mumbai
Work from Office
Role & responsibilities Should perform sample processing smoothly as well as project execution with in assign time. Should handle instrument as well as QA observation. Should coordinate with Group members/ Group leader/ Lab manager Should be able to inspect raw data as per defined procedure. Should report inspection result properly. Should verify calibration record. Should maintain GLP in Lab. Preferred candidate profile 5-6 Years of Experience in Clinical Research Organizations only (Bio-Analytical Department) Qualification: MSC Immediate to 20 days joiners are preferred. You can also share your resumes on: pradnya.raut@accutestglobal.com for quicker callback
Posted 2 days ago
20.0 - 30.0 years
25 - 35 Lacs
panvel
Work from Office
Exp. in ARD/AMD of minimum -20 to 30 years Lead the development and validation of analytical methods Prepare and review technical documentation Drive analytical strategy in global or cross-functional project teams
Posted 2 days ago
2.0 - 7.0 years
2 - 3 Lacs
paonta sahib
Work from Office
Roles and Responsibilities Conduct analytical testing of finished products, including dissolution, UV-Vis, KF, FTIR, and GLP compliance. Develop and validate analytical methods for solid oral OSD products using techniques such as GC, HPLC, and UV spectroscopy. Perform method transfer and validation activities to ensure accuracy and reliability of test results. Collaborate with cross-functional teams to resolve OOS/OOT issues and implement corrective actions. Maintain accurate records of laboratory data, reports, and documentation in accordance with cGMP guidelines.
Posted 2 days ago
3.0 - 8.0 years
2 - 6 Lacs
hyderabad
Work from Office
Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation DQA Department Development Quality Assurance / Formulation Quality Assurance R&D: Handling of QMS documents and Ensure the SOP compliance Review of Formulation Analytical Development Documents & Formulation Product Development Documents. Method Validation and Transfer Protocols and Reports Product development with QbD approach Responsible for ensuring GMP/GLP/GDP compliance in the Formulation and Analytical areas as per the respective SOPs. Review of FRD activities (LNBs, BDRs, PDRs, MFRs and MPR’) SOP’s and Guidelines Preparation and Review and Approval of SOP’s. Responsible for conducting Internal Audits/External Audits for Cross functional Departments in Formulation Division and External Division. Conducting and Coordinating Employee Trainings. Responsible for Review and Approval of Vendor Qualification Should have experience in IPQA and Analytical QA (OSD/Injectable) Ref to Friends or colleagues. Interview Date on 12-07-2025 Company address Plot# 231, IDA Phase -II,, Pashamylaram, Biophore Road, Patancheru, Hyderabad, Telangana, India
Posted 2 days ago
2.0 - 7.0 years
3 - 8 Lacs
bengaluru
Work from Office
Develop and optimize analytical methods (HPLC, UPLC, GC, UV, Dissolution, KF, IR, etc.) for oral solid and oral liquid formulations. Perform analytical method validation and transfer to Quality Control / manufacturing sites.
Posted 3 days ago
4.0 - 8.0 years
4 - 8 Lacs
hyderabad
Work from Office
Job Description: We are seeking a detail-oriented and skilled Analytical Scientist (Five Batch Analysis) with hands-on experience in conducting Phy-Chem and validation studies for agrochemicals and pharmaceutical compounds. The ideal candidate will have strong knowledge of global regulatory guidelines and be capable of preparing study-related documentation while maintaining audit readiness at all times. Key Responsibilities: Conduct Physico-Chemical studies for agrochemical compounds in accordance with regulatory requirements. Act as Study Director for Five Batch Analysis studies in accordance with CRO and GLP regulatory requirements. Develop study plans, protocols, and schedules for analytical method validation and sample analysis. Review raw data, analytical reports, and ensure accurate documentation for regulatory submissions. Perform method validation studies for agrochemical products as per SANTEE/SANCO guidelines. Execute validation studies for pharmaceutical compounds as per ICH guidelines. Carry out dose formulation analysis to support toxicological and regulatory studies. Prepare and maintain Standard Operating Procedures (SOPs) for newly initiated studies. Develop study plans and compile final study reports as per relevant regulatory guidelines. Ensure all studies are conducted in compliance with GLP, OECD, OPPTS, CIPAC, SANCO, and SANTEE guidelines. Maintain effective communication with Quality Assurance (QA) personnel throughout the study lifecycle. Utilize Microsoft Excel for accurate calculations, data analysis, and result interpretation. Remain audit-ready at all times for sponsor audits, NGCMA inspections, or other regulatory reviews. Key Skills: Study Direction & GLP Compliance Five Batch Analysis & Regulatory Submissions Analytical Method Development & Validation HPLC, UPLC, LC-MS/MS Expertise Data Integrity & Quality Assurance Client and Sponsor Interaction Leadership & Team Mentoring Qualifications & Experience: Masters/PhD in Analytical Chemistry / Pharmaceutical Chemistry / Life Sciences or related discipline. 4-8 years of experience in Analytical R&D, QC, or CRO environment with exposure to GLP studies. Hands-on experience with HPLC, UPLC, LC-MS/MS, and other advanced analytical techniques. Prior experience as a Study Director for GLP studies, specifically Five Batch Analysis (mandatory). Regards NagaSravani G nagasravani.g@virinchi.com
Posted 3 days ago
2.0 - 6.0 years
2 - 3 Lacs
baddi
Work from Office
Responsibilities: Collaborate with cross-functional teams on product development Ensure compliance with regulatory standards Conduct method validations and HPLC analysis Monitor QMS procedures and document changes
Posted 3 days ago
3.0 - 7.0 years
0 Lacs
vadodara, gujarat
On-site
As a candidate for this role, you will be responsible for working in accordance with organizational compliance requirements. Your main tasks will include developing methods for various quality attributes for complex injectable drug products such as Liposomes and Ophthalmic Drug products. You will also be in charge of performing method validation and verification, as well as analyzing drug products using a variety of analytical techniques including HPLC, GC, UV, and other relevant methods. In addition, you will be tasked with identifying, investigating, and troubleshooting issues as they arise. Your responsibilities will also involve conducting chemical analyses such as Extraction, Refluxing, Residue on ignition, Centrifuging, and Evaporation. Furthermore, you will be expected to prepare study templates, analytical method validation and verification reports, as well as protocols to support your findings. Overall, this role will require a high level of attention to detail, strong analytical skills, and the ability to work effectively within a regulated pharmaceutical environment.,
Posted 1 week ago
0.0 - 4.0 years
0 Lacs
ahmedabad, gujarat
On-site
As an Analyst or Senior Analyst in Bioanalytical Research at Veeda Lifesciences, you will play a crucial role in conducting bioanalytical research activities. This includes method development, validation, and sample analysis utilizing a variety of techniques such as HPLC, GC, mass spectrometry, chromatography, spectrophotometry, and polarimeter. Your responsibilities will also involve developing and validating methods for bioanalysis of biologics and biosimilars in compliance with regulatory requirements, such as those set by the USFDA. Collaboration with cross-functional teams will be essential to ensure the timely delivery of high-quality results. Additionally, you will be tasked with performing stability testing of biological products under different conditions. Troubleshooting issues related to instrument calibration, maintenance, and operation will also fall within your scope of duties. The ideal candidate for this role should hold a Bachelor's degree in Pharmacy (B.Pharm) or a Master's degree in Pharmacy (M.Pharm) from an accredited institution, or alternatively an M.Sc. degree. Previous experience ranging from 0 to 4 years is preferred. A strong understanding of analytical instruments like HPLC, UPLC, GC, MS, ICP-MS, and wet analysis is highly desirable for this position.,
Posted 1 week ago
5.0 - 7.0 years
7 - 13 Lacs
Hyderabad, Telangana, India
Remote
Job description Lead the verification and validation of analytical and microbiological methods, ensuring they meet all regulatory and internal quality requirements. Design, execute, and document method validation protocols, including accuracy, precision, specificity, and robustness studies, in compliance with FDA, TGA, ICH, and EMA guidelines. Review and approve validation protocols and reports, ensuring they are scientifically sound and fully compliant with Good Laboratory Practice (GLP) and other relevant regulatory standards. Analytical and Microbiology Methods: Provide expert review and oversight of analytical and microbiological testing protocols, data, and reports, ensuring compliance with regulatory standards and internal quality systems. Oversee the development, validation, and implementation of new analytical and microbiological methods and, including but not limited to chemical analysis, sterility testing, microbial limits testing, and endotoxin testing. Ensure that all methods are validated to provide reproducible and accurate results, adhering to FDA, TGA, ICH, and EMA requirements Data Review and Integrity: Conduct thorough reviews of raw data and final reports related to analytical and microbiology testing and method validation. Ensure that all data generated during analytical and microbiological testing is accurate, complete, and adheres to the approved protocols and SOPs. Identify and resolve any data discrepancies or deviations from established protocols. Regulatory Compliance: Ensure that all analytical and microbiological methods and validations comply with FDA, TGA, ICH, and EMA regulations. Assist in the preparation of documentation for regulatory submissions, providing quality assurance support for analytical and microbiological data and validation reports. Continuous Improvement: Contribute to the development and continuous improvement of quality systems related to analytical and microbiological methods and validation processes. Participate in root cause analysis of quality issues and support the implementation of corrective and preventive actions (CAPAs). Training and Development: Provide guidance and training to R&D staff on best practices in analytical and microbiological testing, method validation, and quality assurance. Act as a mentor and resource for junior staff in the areas of analytical development, microbiology and quality assurance What you d gain: Invaluable hands-on experience working alongside seasoned developers. Opportunity to learn and grow in a supportive environment. Gain exposure to the entire software development lifecycle. Contribute to real-world software projects and make a positive impact. Qualifications: Bachelor s degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or a related scientific discipline is required. Advanced degree (Master s or Ph.D.) in a related field is preferred. Minimum of 5-7 years of experience in quality assurance with a focus on analytical, microbiology, method verification, and validation within the pharmaceutical, biotech, or life sciences industries. Extensive experience with analytical and microbiological testing methods, including method verification, validation, sterility, microbial limits, and endotoxin testing. Strong expertise in analytical and microbiological methods and their application in product development. Excellent attention to detail and analytical skills with a focus on data integrity and accuracy. Strong written and verbal communication skills, with the ability to document and present complex technical information clearly. Ability to work effectively in a team-oriented environment and collaborate across multiple departments. Proficiency with quality management systems and software tools. This position is remote and may require occasional travel to other sites or meetings. The role may involve working in a laboratory environment with exposure to chemicals and biohazardous materials.
Posted 2 weeks ago
1.0 - 3.0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
Date: 4 Aug 2025 Location: Bangalore, KA, IN, 560100 Custom Field 1: Development Services Job Description Designation: Research Associate/ Executive/ Analyst, Small Molecule Bioanalytical Research Laboratory, Clinical Development Job Location: Bangalore, India Reporting to: Group Leader of Small Molecule Bioanalytical Laboratory Job Grade: Level 9-I The Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngenes 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA. The Role The Research Associate/ Executive/ Analyst for the Small Molecule Bioanalytical Laboratory is a technical role responsible for conducting BA/BE studies in the laboratory. Job responsibilities include performing critical method development and validation programs, technical and regulatory compliance of all studies. This role requires an individual with a robust background in pharmaceutics, or other related life sciences, coupled with extensive experience in the bioanalytical field, particularly within small molecule bioanalysis. This role demands an individual with a strong commitment to compliance, integrity, and excellence in bioanalytical research, particularly in small molecule analysis. The role reports into the Project Leader / Group Leader, Small Molecule Bioanalytical Laboratory and is a full-time position based out of Bangalore, India. Key Responsibilities Of The Role Perform the bioanalytical work including sample processing for method development, method validation and study sample analysis as per the protocol in compliance with SOPs, STPs. Prepare STP, MV protocol and study sample analysis protocol. Coordinate with maintenance department for any problems related to utilities and equipment / instrument (e.g. LC-MS/MS, HPLC, etc) failures. Document data generated, entries in official documents. Ensure all studies adhere to regulatory guidelines and expectations set by GCP/ GLP. Participate in all discussions on project-specific scientific details. Education And Experience Education Masters in Pharmaceutics or other related life sciences from a reputed university. Industry Experience Minimum of 1 years of experience in regulated small molecule bioanalysis Hands-on experience in small molecule regulated bioanalytical experiments People Leadership Experience NA Exposure And Experience Experience with working for a Bioanalytical CRO lab will be an added advantage. Core Competencies Required For The Role Scientific: Brings a creative and an innovative advantage to projects Is curious, eager to learn and make a difference Thinks scientifically and understands the problem statement in assigned programs/assays Publishes posters, papers and articles regularly Technical Conducts/plans experiments without errors and gaps Reports/analyzes data punctually and communicates effectively Troubleshoots and investigates logically (is able to defend the logic behind experimental results) Is able to forecast risks and make mitigation plans ahead of time Has good organizational, project management skills Documentation Records data as per ALCOA++ policy Pays attention to detail Is punctual in responding to QC and QA reports Displays minimal audit finding index Writes clearly and concisely with English skills at >B+ 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. Pls visit us at https://syngeneintl.com/ to know more about us and what we do. Show more Show less
Posted 2 weeks ago
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