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2 - 7 years
3 - 7 Lacs
Navi Mumbai
Work from Office
Roles and Responsibilities To analysed & develop analytical method for the existing and new molecules. To calibrate and validate the developed method as per the global standards. To operates and maintains various analytical instruments To document the developed process along with its calibration and validation data. To transfer developed method to the quality control with the help of right technology transfer protocol. To support organization in terms of achieving various quality accreditations. Prepare COA (certificate of analysis) for finished goods lot as per specifications Carry out standardization & calibration of LAB reagents and instruments & maintain records as per SOP Carry out safe and standard operations of instruments/ Lab wares as per SOP Maintain safe work practices by using applicable PPEs (Personnel protective equipment) w.r.t LAB Maintain good housekeeping in the laboratory Segregate the waste as per properties of the material/chemical To maintain experimental data in ELN and LIMS. To maintain instruments and equipments of the lab. To support structural identification of impurities and by-products. To support waste characterization. To support synthesis lab, Kilo Lab, Pilot plant in terms of process development and scale up quality needs. Provides Training and supervision to new executives on analytical methods Actively searches literature in research publications, patents, etc Follow BBS (Behavior based safety) to maintain safety culture at workplace Prepares technical reports and presentations as required related to projects Supports R&D projects at group level participating in meetings and sharing technical information and "best-practices Encourages "best-practice" sharing through the participation and promotion of meetings, knowledge sharing tools and all other initiatives liaising on a world-wide basis Should have thorough knowledge for the operation and calibration of ICP-MS/ ICP-OES instrument/s. Should have thorough knowledge for the troubleshooting and maintenance of ICP-MS/ ICP-OES instrument/s. Able to work individually for elemental impurities analysis and other assigned tasks in shifts. Skills: Polymer chemistry: GPC, LCMS, GCMS Interpretation by / Different Techniques of NMR, IR, LCMS, GCMS, ICP-MS, ICP-OES. Wet Analysis, Gas Analysis. Ion Chromatography. Impurity Isolation, Characterization. Knowledge: Particle Size by microscopic techniques like SEMTEM, TGA, DSC, CHMS. Bet Surface Area. Desired Candidate Profile M.Sc Analytical Chemistry or M.Sc (Chemistry with large industrial experience in analytical method development and structure elucidation.)
Posted 3 months ago
3 - 8 years
4 - 9 Lacs
Vadodara
Work from Office
Role & responsibilities Develop and optimize analytical methods for trace level quantification of other impurities in drug substances and products. Validate analytical methods to ensure accuracy and reliability by LCMS. Routine Analytical Method Transfer for Impurity by LCMS/MS. Routine Analysis of Finished goods, RM by LCMS. Routine Analysis of Cleaning Validation Sample by LCMS. Plan, organize, and document scientific experiments according to quality standards. Troubleshoot analytical methods and instrumentation issues. Collaborate with project teams to support project deliverables. Maintain GMP standards in testing and documentation. Implement and maintain lean, efficient, and sustainable practices in the laboratory. Preferred candidate profile Communication Skills: Strong analytical, problem-solving, organizational, and time management skills. Minimum 3 to Maximum 10 Years of experience required Experience: Hands-on experience in API based pharmaceutical analytical methods. Regulatory Knowledge: Familiarity with ICH guidelines, cGMP, and regulatory requirements for analytical testing. Technical Skills: Expertise in trace level quantification techniques such as LC-UV/FID, Ion Chromatography, LC-MS, GC-MS, and high-resolution mass spectrometry.
Posted 3 months ago
5 - 10 years
0 - 0 Lacs
Mohali
Work from Office
1) Experience in preparing and reviewing of Method Development Report. 2) Knowledge of ICH Guidelines. 3) Strategic planning and performing Validation studies, Solubility Studies, Impurity and Standard Qualification. 4) Exposure of working on HPLC, LCMS, GC, UV and other equipment. 5) Ability to perform an analysis of related substances, assays and purity by using HPLC, IC. 6) Ability to perform analysis of residual solvents by using gas Chromatography. 7) Preparation and Review of development and validation/ method transfers/ protocols and reports based on R&D qualifications or monographs. 8) Ability to work in a team and contribute towards collective goals.
Posted 3 months ago
3 - 8 years
3 - 7 Lacs
Hyderabad
Work from Office
Key Responsibilities Need to have strong theoretical knowledge (HPLC/LCMS/Prep.HPLC/SFC) Plan and conduct the analysis with required skills. Record the observations meticulously and update to the TL/SME. Share and discuss the observations with supervisor. Independent in maintaining the instrument and setting up the instrument for analysis. Expected to be aware of basics in analytical chemistry (basic analytical techniques Theory and application) as well as handling of laboratory equipment / instruments with basic understanding. Expected to be aware and working in a safety compliant manner
Posted 3 months ago
1 - 5 years
0 - 0 Lacs
Gurgaon
Work from Office
Hiring for Technical officer - Mass spectrometry facility Applications are invited for technically qualified candidates for Technical Officer position at Amity Lipidomics Research Facility (ALRF). Period of Engagement: Initially for a period of one year which can be extended as per performance of the candidate. Essential qualification: Candidate must have postgraduate degree of M.Tech/M.Sc. in Chemical Sciences/Pharmacy/Life Sciences/Instrumentation with demonstrable research experience. Desirable qualification: Candidate should have handled LCMS and GCMS, preferably handling triple stage quadrupole/linear ion trap mass spectrometer, Q-Trap 4500 (SCIEX). How to apply: Interested candidates may submit their resumes at sgoel@ggn.amity.edu latest by 24th March, 2025 with the following details - Details of Academic & Professional/Technical Qualifications Details of past experience & present employment Present Pay/emoluments Names and complete addresses along with E-mail and Phone No. of three independent responsible persons as referees who can comment on the candidates suitability and temperament. https://www.amity.edu/gurugram/lipidomics-research-facility.aspx Amity Institute of Biotechnology, Amity University Haryana, Gurgaon (Manesar) - 122413
Posted 3 months ago
3 - 8 years
3 - 8 Lacs
Chennai, Bengaluru, Hyderabad
Work from Office
• Must have experience in analytical method development of peptide molecules. • Experience in method development of peptide molecules and Fmoc-Amino acids by HPLC and UPLC techniques. • Experience in handling of various peptide related analytical methods like AAA(Amino acid analysis), SEC(Size exclusive chromatography), Peptide Assay, Oligomers content. • Knowledge in characterization data of peptides i.e. Amino acid sequencing by LC-MS/MS by Q-Tof, HRMS and NMR. • Experience in handling of routine analysis of peptides by HPLC, GC, ICPMS and wet analysis.
Posted 3 months ago
1 - 6 years
3 - 8 Lacs
Bengaluru
Work from Office
Designation: Senior Research Associate/ Executive/ Analyst Job Location: Bangalore, India Reporting to: Group Leader of Bioanalytical Research Laboratory 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 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.
Posted 3 months ago
8 - 12 years
9 - 12 Lacs
Hyderabad
Work from Office
GTI & NDSRI by using LCMS. Review of Method Development & Method Validation Data Preparation of Protocols & Validation Reports Handling of Incidents, Deviations & Change Controls.
Posted 3 months ago
3 - 7 years
4 - 7 Lacs
Hyderabad
Work from Office
Regular Batch Analysis by using LCMS. Preparation and analysis of method validation, method transfer, method verification and method development protocols and reports. Experience in GTI & NDSRI by LCMS
Posted 3 months ago
10 - 12 years
4 - 9 Lacs
Hyderabad
Work from Office
1. Responsible for performing analysis by LC-MS/GC-MS/Ion chromatography analysis to identify and quantify impurities in different types of pharmaceuticals products. 2. Impurity profiling in the different pharmaceuticals products or NCEs by LC-MS/MS or GC-MS. 3. Have an expertise and experience in method development and optimization LC-MS methods for identification, detection, separation and quantification of target compound like GTIs and Nitrasoamine impurities. 4. Structure Elucidation Reports preparation by using Mass and NMR analysis 5. Handling of AB Sciex Q TRAP 4500 and Waters HRMS MSC chemistry with 10-12 years of experience
Posted 3 months ago
2 - 7 years
3 - 8 Lacs
Navi Mumbai
Work from Office
Job description Job Title: Senior Research Associate / Executive Analytical Laboratory - HRMS,LCMS, GCMS, ICPMS & IC Location: Rabale, Navi Mumbai Department: Analytical Method Validation Reports to: Manager/Senior Manager Position Type: Full-time Position Summary We are looking for a skilled and detail-oriented Senior Research Associate/Exectuive to join our dynamic team at Fusion Scientific Laboratories, a leading USFDA and EMA accredited pharmaceutical laboratory. The successful candidate will play a key role to operate and maintain advanced analytical instruments such as GC-MS/ ICP-MS/ IC/ LC-MS/HR-MS. The ideal candidate will support method development and validation, and ensure accurate and timely data reporting. This role is crucial for delivering high-quality analytical results to support research, product development, and quality control initiatives. Key Responsibilities: Operate and maintain analytical instruments including GC-MS/ ICP-MS/ IC/ LC-MS/HR-MS. Perform routine and specialized analyses on various samples in compliance with established protocols and regulatory requirements. Support method development, optimization, and validation for new and existing analytical procedures. Prepare samples, reagents, and standards for analysis, ensuring accuracy and consistency. Perform data acquisition, processing, and interpretation, and compile results into detailed reports. Maintain detailed laboratory records and ensure compliance with GLP/GMP, ISO, or other applicable standards. Conduct regular instrument calibration, performance checks, and maintenance to ensure precision and reliability. Stay updated on advancements in analytical techniques and instrumentation. Adhere to all safety and regulatory requirements within the laboratory environment. Collaborate with cross-functional teams to support research and development, quality control, and other organizational needs. Qualifications : Masters degree in Chemistry, Analytical Chemistry, Biochemistry, or a related field. 26 years of experience in operating analytical instruments such as GC-MS, ICP-MS, IC, and LC-MS. Technical expertise in analytical method development and validation. Proficiency in data interpretation and reporting, with attention to detail. Familiarity with GLP, GMP, and other relevant regulatory standards. Problem-solving and time management skills. Ability to work independently and collaboratively in a team-oriented environment. Knowledge of software used in analytical instrumentation (e.g., Chromeleon, Analyst, Lab solution, Empower software would be added advantage). Work Environment : Laboratory-based role with adherence to SOPs and safety protocols. May require occasional extended hours to meet project deadlines. Fusion Scientific Laboratories is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Posted 3 months ago
2 - 5 years
0 - 2 Lacs
Dahej
Work from Office
Designation- Officer/ Sr. Officer- Quality Control (API) Location:- Dahej Qualification:- B.Pharm/ M.Pharm/ MSc Experience:- 2-5 years of experience into LCMS, HPLC, GC & Wet Chemical sections
Posted 3 months ago
1 - 4 years
1 - 4 Lacs
Bengaluru, Manipal
Work from Office
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 1-4 years of experience in Bioanalytical Lab.
Posted 3 months ago
2 - 7 years
3 - 7 Lacs
Hyderabad
Work from Office
Roles and Responsibilities Develop analytical methods for biochemistry samples using GC-MS, LCMS, and other relevant techniques. Conduct method validation, optimization, and transfer to ensure accuracy and reliability of results. Collaborate with cross-functional teams to resolve method-related issues and improve overall efficiency. Maintain accurate records of experiments, data analysis, and reporting in accordance with regulatory requirements. Stay up-to-date with industry developments in mass spectrometry technologies and apply this knowledge to improve laboratory operations. Desired Candidate Profile 2-7 years of experience in Analytical Method Development & Validation (GC-MS & LCMS). MS/M.Sc(Science) degree in Bio-Chemistry or Chemistry from a recognized university. Strong understanding of chromatography principles, including HPLC/UPLC systems. Proficiency in developing analytical methods for biochemistry samples using various instruments such as GC-MS/MS.
Posted 3 months ago
1 - 3 years
1 - 3 Lacs
Bengaluru
Work from Office
Role & responsibilities Preferred candidate profile
Posted 1 month ago
3 - 8 years
8 - 15 Lacs
Thane
Work from Office
About Company: Legrand is a global specialist in electrical and digital building infrastructures. Legrand's purpose is to improve life by transforming the spaces where people live, work and meet with electrical and digital infrastructure and connected solutions that are simple, innovative and sustainable. Legrand is head-quartered in Limoges, France and has over 36,000 employees across the world. Legrand has been in India since the late 1990s and follows a multi-brand strategy in the region - in addition to the Legrand brand, the Group in India owns the brands Numeric, IndoAsian, Adlec, Netrack, Valrack and Raritan. Group Legrand India has a strong Sales/Commercial presence and is present in 80+ key locations, with 7 manufacturing sites. Legrand France runs business in India with registered name as Novateur Electrical & Digital Systems Pvt. Ltd. (NEDSPL). Key Focus: Design, develop, validate, and enhance Circuit Breaker (ACB/MCCB/MCB/RCCB) / Switch Disconnector products by collaborating with cross-functional teams to ensure high-quality, standard-compliant products aligned with market needs and innovation goals. Roles and Responsibilities: Lead concept design and development of new Circuit Breaker / Switch Disconnector products. Provide detailed design outputs and specifications in both 2D and 3D formats . Validate prototypes and samples through rigorous testing to meet design and functional requirements. Analyze test results and implement improvements to ensure full compliance with safety, performance, and marketing specifications. Create and maintain item codes , engineering BOMs , and product documentation . Collaborate closely with R&D Industrialization, CPD, QA, and Manufacturing Engineering for product development and qualification. Support the development and qualification of tooling, jigs, and fixtures for new and existing products. Drive lifecycle management and continuous enhancements of Circuit Breaker / Switch Disconnector product lines. Lead change management initiatives with a target of over 90% on-time implementation . Functional Competencies: Core experience in product design for ACB/MCCB/MCB/RCCB / Switch Disconnector is essential. Expertise in design and simulation tools such as Creo, ProE, SolidWorks, AutoCAD, CATIA , etc. Strong knowledge of electromechanical design , materials, and product standards. Proficient in MS Office (Excel, Word, PowerPoint) and enterprise PLM/ERP systems. Excellent analytical, problem-solving, and documentation skills. Strong communication, presentation, and collaboration skills across functions. Qualifications & Experience: Bachelor's degree in Mechanical or Electrical Engineering. 3-10 years of experience in product development for low-voltage switchgear, specifically circuit breakers and switch disconnectors. Good understanding of relevant certifications, standards (IEC/IS), and testing protocols. Experience with cross-functional project management in a structured development environment.
Posted 1 month ago
- 3 years
2 - 5 Lacs
Hyderabad/ Secunderabad
Work from Office
Walk-In Drive : Analytical Services Required Qualification & Experience: M.Sc. Chemistry/Analytical/M-Pharmacy, with 0 - 3 Years of experience in the field of pharmaceutical industry/CRO setup. Candidate should have knowledge in method development and validations by GCMS /LC-QTOF. Candidate should have knowledge on GLP/cGMP. Good to have experince in E&L. Job Responsibilities Carries out experimentation in the area of GCMS/LC-QTOF for E&L studies. Records experimental data, ensuring clear and accurate transcription of results and calculations. Completes assigned work with quality and in a timely manner. Assists the group leader in instrument qualifications, implementing laboratory procedures and systems. Coordinates with other team members as per requirement. Follows QMS (cGMP/GLP) practices and aspects related to policies, safety and compliance. Performs in-charge duties for the allocated lab/equipment/inventory/supporting activities and takes responsibility for the timely completion of the tasks assigned. Demonstrates a strong desire to continue learning and grow personal capability. Performs other duties as assigned. Please bring your Updated CV along with 3 Months Payslips, Recent Increment Letter, Aadhar Card/PAN Card: Date : Saturday, 17th May 2025 Time: 09:00 AM to 4:00 PM Walk-in Interview Location: Daicel Chiral Technologies (India) Pvt Ltd Genme Valley, IKP Knowledge Park, Survey No. 542/2, Koltur Village, Shamirpet Mandal, Medchal-Malkajgiri District, Hyderabad-500101 Note: Candidates who are unable to walk-In, May send their resume to hr@chiral.daice.com or whatsApp to 7207760479
Posted 1 month ago
2 - 7 years
2 - 7 Lacs
Hyderabad, Navi Mumbai, Ahmedabad
Work from Office
Openings for Residue analysis persons in Food Testing - Hyderabad , Navi Mumbai , Ahmedabad Designation : Junior / Senior Analyst Experience: 2- 10 Years Department : Residue Location : Hyderabad Qualification : M.Scs. (Organic Chemistry/Chemistry/Analytical chemistry) Industry : CRO & Testing Laboratory (Third party testing lab ) Roles and Responsibilities: Analysis of Pesticide residues of Food and Agriculture products as per SOPs, IS, AOAC, FSSAI. Method development, validation and report preparation. Operation and Calibration of equipment i.e., LC-MS/MS, GC-MS/MS, Analysis of Pesticide residues in Water samples. Analysis of Antibiotics in Aqua & Marine products, Feed, Milk & Milk products. Analysis of Pesticide Residues in Fruits and vegetables, Milk & Milk products, Feed & Feed Products and Miscellaneous samples. Mycotoxin analysis in Food & Agricultural products and feed samples. Use and calibration of instruments such as Micro Pipettes, Analytical Balance, Micro balance, Centrifuge, Turbo Evaporator, HPLC & GC. Analysis of Residue in food by LC MS/MS,GC MS/MS, method development and validation, food additives, contaminants analysis on HPLC,GC with different detectors, Worked in ISO 17025:2017 and FSSAI approved lab NABL audit will be added advantage. Regards, Priyanka Jajula
Posted 1 month ago
years
0 - 1 Lacs
Bengaluru
Work from Office
Preferred Qualification: M.Sc Organic Chemistry with more than 70% aggregate Looking for freshers who can join immediately Roles & Responsibilities: Synthesize, and characterize novel bioactive molecules under supervision of scientist/senior scientist Knowledge of modern organic chemistry and synthetic methods: heterocyclic chemistry, metal catalysed reactions, multi-step synthesis. Knowledge of techniques in synthesis, purification, and spectroscopic characterization of novel compounds (NMR, LCMS, HPLC, etc.). Maintain Lab note book. Understanding of systems and process pertaining to safety, health and environment. LAST DATE for application: 14th May 2025. Selection Process: Candidates who have applied shall be shortlisted based on their academic marks. Technical test and aptitude test will be conducted online on 15th May 2025. Interviews will be scheduled on 17th May 2025 for the shortlisted candidates at Aurigene Oncology Ltd, Bangalore.
Posted 1 month ago
3 - 4 years
2 - 3 Lacs
India, Gujarat
Work from Office
Supervision of Sampling, Sample preparation, Sample Analysis, Instrument Calibration, Documentation etc.
Posted 1 month ago
12 - 18 years
10 - 14 Lacs
Pune, Hinjewadi
Work from Office
We are hiring for a Public listed BSE / NSE - Pharma - API / Crop Protection / Animal Health Intermediates Mfg CDMO / CRAM Company. Role : Team Leader - ADL Title : Sr. Scientist R&D Centre Level : Deputy Manager CTC : Ceiling Rs 15 Lpa Experience: Minimum 14 years to Max 18 years Those working at R&D Centres of Crop Sciences / API / Specialty Chemicals are only eligible. Formulations / Vaccines / Bio labs are not eligible. Formulations Qualification : Full Time M.Sc in Organic Chemistry / Analytical Chemistry only. Those in other specialisation of Chemistry are not eligible. Those with Correspondence Masters degree won't qualify. Location: Pune Saturdays: 2nd / 4th Not working Local Company Transport on the major Trunk Road available. Those working in QC Labs not eligible. Those working in Foods Lab not eligible. Those working in Testing Laboratories should not apply. Role: To follow Good laboratory Practices. To follow the procedures mentioned in SOP's and General test Procedures To ensure availability of respective working standards/samples for method validation and method transfer activity To monitor periodic calibration of instruments as per the schedule To follow all safety standards while working To fulfil the requirement of RA department for different filings To review method validation data & preparation of respective protocol reports To ensure documentation of analytical activities as per Co. policy To provide complete support for internal & external Audits at Pune location To develop suitable analytical methods to support cross functional teams To prepare and review method validation protocols, data and reports
Posted 1 month ago
5 - 9 years
7 - 9 Lacs
Ankleshwar, Panoli
Work from Office
Position: Astt Manager - QA Qualification: B.Sc / M.Sc in Chemistry Experience: 6 years to 10 years in QA CTC can go maximum to Rs 9 Lacs per Annum. Location: Ankleshwar / Panoli. Transport Provided. Industry: API PHARMA ONLY Responsibility: Support MR in QMS Responsible for driving Quality Mindset. Support IMS Audits, FDA , Vendor Audits. Strong in Document Control and Process Documentation. Should have supported US FDA Inspections and Audits KEYWORDS: GMP, FDA, IMS, QMS, AUDITS
Posted 1 month ago
years
0 - 1 Lacs
Bengaluru
Work from Office
Preferred Qualification: M.Sc Organic Chemistry with more than 70% aggregate Looking for freshers who can join immediately Roles & Responsibilities: Synthesize, and characterize novel bioactive molecules under supervision of scientist/senior scientist Knowledge of modern organic chemistry and synthetic methods: heterocyclic chemistry, metal catalysed reactions, multi-step synthesis. Knowledge of techniques in synthesis, purification, and spectroscopic characterization of novel compounds (NMR, LCMS, HPLC, etc.). Maintain Lab note book. Understanding of systems and process pertaining to safety, health and environment.
Posted 1 month ago
3 - 6 years
6 - 9 Lacs
Bengaluru
Work from Office
At Syngene, Safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and sops, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards always Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Performing analytical method validations and related documentation, as well as analysis of RM, PM, Intermediates, API, and Finished products. Key Responsibilities: Performing Chromatographic and Non-chromatographic analysis for Drug substances, Drug products, Intermediates, Excipients, etc ). Conduct the analysis on qualified techniques per the approved specification / protocol / procedures , interpret the data from analytical instruments, report the results, and promptly submit the completed documents for review within the established window. Recording of analytical observations/findings, reporting of data and results in observation data sheets, forms, logbooks, LIMS, and ELN application software, and support in preparing stability summary reports and review of final documents. Responsible for timely intimation/investigation of any events or deviations to the Department Head, QA function, supporting the related investigations to the clients, and timely closure. Instrument calibration as per schedule, hot water flushing of HPLC, and general preventive checks for laboratory instruments. Perform validation activities and method transfers for multiple client projects. Actively participate in client and regulatory audits. Ensure to follow cGMP and GDP. Preparing the certificate of analysis for standards and impurities and Reports for Analytical Method Validation and Analytical Method Transfer. Support in performing Qualification and Calibration of assigned Instruments and Equipment. Create/prepare documents, master data, and static data in LIMS, ELN, and LMS software as applicable. Outsourcing of sample testing is based on requirements and updating in respective logbooks. Coordination with engineering & maintenance and external vendors for preventive maintenance and calibration activity. Support in preparation of instruments URS, DQ, and IOP. Supported preparing standard operating procedures and uploading data in LIMS and other relevant activities per departmental requirements. Use of required safety PPE while sampling, analyzing, and working in the Laboratory. Individuals working in the GMP environment are responsible for documenting/recording the activities contemporaneously and accurately as per good documentation practices. Ensure safety compliance as per Syngene policy and EHSS requirements. Taking any other jobs by the Head QC/Group Leader/Designee. To ensure safety compliance as per Syngene policy and EHSS requirements. Educational Qualification: M Sc / M Pharma (Analytical/General chemistry) Technical/Functional Skills: Should be well versed with the latest analytical techniques like HPLC/GC, KF/KFC, IR/UV, LC-MS, GC-MS, IC, ICP-OES/ICP-MS, DSC, TGA, etc... Being well-versed in the Chromeleon data management application and LIMS will be advantageous. Experience: 3- 6 years
Posted 1 month ago
10 - 15 years
8 - 15 Lacs
Bengaluru
Work from Office
We are seeking a highly motivated and experienced Study Director to oversee chemical characterization studies within our research and development team. The ideal candidate will have a strong background in analytical chemistry, extensive knowledge of chemical characterization techniques, and a proven track record in managing complex projects. Key Responsibilities: - Lead and manage chemical characterization studies, including planning, execution, and reporting of results. - Develop study protocols and ensure compliance with regulatory guidelines and internal standards. - Coordinate and communicate with cross-functional teams. - Analyze and interpret data, preparing comprehensive reports and presentations for internal and external stakeholders. - Mentor and train junior staff in scientific techniques and best practices. - Ensure that laboratory safety protocols are followed and maintain a clean and organized work environment. - Stay current with industry trends and advancements in chemical characterization methodologies. Qualifications: - Ph.D. or equivalent degree in Chemistry, or a related field. - A minimum of 10 years of experience in chemical characterization or a similar role within a laboratory setting. - Expertise in techniques such as LCMS - QTOF, GCMS, NVR, ICPMS, IC and other relevant analytical methods. - Strong project management skills with the ability to lead multiple projects simultaneously. - Excellent communication, organizational, and problem-solving abilities. - Familiarity with regulatory requirements and guidelines in the pharmaceutical or biotechnology industry. This position offers a competitive salary and benefits package, along with opportunities for professional growth and development. If you are passionate about advancing scientific research and thrive in a collaborative environment, we encourage you to apply. Roles and Responsibilities 1. Oversee and manage chemical characterization studies from initiation to completion, ensuring adherence to regulatory standards and internal protocols. 2. Design study plans and methodologies that are scientifically sound and aligned with project objectives, including the selection of appropriate analytical techniques and equipment. 3. Coordinate with cross-functional teams, including project managers, chemists, and quality assurance personnel, to ensure effective study execution and communication. 4. Review and approve study protocols, analytical methods, and reports to ensure accuracy, compliance, and scientific integrity. 5. Provide technical expertise and guidance related to chemical characterization, including the interpretation of analytical data and results. 6. Ensure that all studies are conducted in compliance with Good Laboratory Practice (GLP) and other relevant regulations. 7. Manage study budgets and timelines, identifying potential risks and implementing mitigation strategies to ensure successful project delivery. 8. Train and mentor staff on appropriate methodologies and regulatory requirements related to chemical characterization studies. 9. Participate in project meetings, presenting study findings and progress updates to stakeholders, and incorporating feedback into study design and implementation. 10. Maintain up-to-date knowledge of industry trends, emerging technologies, and regulatory changes affecting chemical characterization and related fields. 11. Facilitate communication with regulatory agencies as needed, providing data and documentation to support submissions and inquiries. 12. Contribute to the continuous improvement of departmental processes and methodologies, ensuring best practices are followed in study design and execution.
Posted 1 month ago
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