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3.0 - 8.0 years
9 - 12 Lacs
Gurugram
Work from Office
Setting strategy for evaluating and implementing new technologies within the Analytical Development department, with a particular emphasis on state-of-the-art separation techniques (HPLC/UPLC/LCMS/GC) and familiar with XRD, DSC etc and automation Troubleshoot as appropriate for successful execution with intimation to supervisor Scale up of R&D developed products to kg scale and then technology transfer to pilot plan Required Candidate profile Preparation and review of Specifications, Method of analysis procedures and Analytical development reports Feel free to reach me on email
Posted 1 day ago
4.0 - 9.0 years
3 - 6 Lacs
Bharuch
Work from Office
JOB DUTIES and RESPONSIBILITIES (Please MentionInBelow Table) 1 Perform the testing of Raw Material/Finished goods/Inprocess materials and report the results. 2 Handle the analytical instruments like HPLC, UPLC, GC, ICP, DSC, XRD, PSAetc 3 Calibration of the Analytical instruments as per the master calibration schedule 4 Investigate the analytical error/deviations during analysis and find out the root cause. propose appropriate corrective and preventive actionforthe same 5 Experienceinmaking lab SOPs and study reports 6 Execute method validation and prepare the necessary reports 7 Reviews analytical chemistry testing records of raw materials, stability, and productforaccuracy and adherence to test methods 8 Preparation and review of Specifications, Method of analysis procedures and Analytical development reports 9 Preparation and review of Specifications, Method of analysis procedures and Analytical development reports 10 Discuss work plan on daily basis with supervisor/ manager and Mentor junior lab personnel 11 Participateinproject meetings and prepare weekly and monthly reports and submit to Manager 12 Regular lab duties including equipment maintenance,chemicalinventory and lab clean-up 13 Maintain strict IP Confidentiality and adhere to all related data privacy policies
Posted 1 day ago
4.0 - 9.0 years
4 - 6 Lacs
Bharuch
Work from Office
Job description Perform the testing of Raw Material/Finished goods/In process materials & report the results. Handle the analytical instruments like HPLC, UPLC, GC, ICP, DSC, XRD, PSA Calibration of the Analytical instruments as per the master calibration schedule Required Candidate profile Preparation and review of Specifications, Method of analysis procedures and Analytical development reports
Posted 1 day ago
2.0 - 7.0 years
3 - 8 Lacs
Udaipur
Work from Office
Job Description Strategic Responsibilities To understand the scope of the project assigned. Inputs in planning of analysis of samples received Log entries and calibration of assigned instruments (as applicable) Proper house- keeping and use of PPEs. Use relevant MSDS for safe handling and disposals of bio chemicals / samples Operational Responsibilities Co-ordination with Project Management in understanding sample receipt. Plan and conduct analysis Authenticity of the result generated Troubleshooting Data interpretation of microbial data ological experiments with appropriate controls On-line data logging into E-note book / LIMS System at ADL or any other platform (as applicable) Data compilation and time to time update to Project Management team Financial Responsibilities Contribute to budgetary controls within the area of responsibility. People Responsibilities Utilization of all available sources for skill up-gradation Actively participation in problem solving sessions/ training programs Coordination and communication with team members. Educational Qualification Master in Microbiology from a reputed University / Institute Experience - 2 to 7 years experience in microbiology QC work, bacterial CFU determination and contamination checking. Experience in handling of automated colony counter and inhibition zone reader will be an added advantage. Industry to be hired from Agro chemicals/fine chemicals/ pharma-API/ Specialty chemicals. Functional Competencies Scientific Knowledge Documentation, Data Analysis & Tech Transfer Regulatory Compliance and Data Integrity EHS and Compliance Interested candidates please share your resumes on shubhi.chandnani@piind.com or call on 8875001305 for further details.
Posted 3 days ago
3.0 - 8.0 years
3 - 8 Lacs
Ahmedabad
Work from Office
Analyst Analysis of raw material, Drug substance (API), drug products by HPLC, GC, UV-Visible Spectrophotometer, IR, SOR Instruments and chemical analysis (wet lab). Calibration of laboratory Instrument like UV-Visible Spectrophotometer, Balances, pH meter, KF Titrator, etc., and Preparation and maintenance of volumetric solutions, buffers, etc Exposure of GMP / GLP / GDP in laboratory. Designation - Officer / Sr. Officer /Executive Experience : 02 - 07 years Must be having experience in API Reviewer Analytical method development and validation of raw material, in-process and finished products by HPLC, GC, Dissolution apparatus. Review of analytical method validation / verification protocols and reports. Communication with R&D, RA, QA and QC department for to resolving method related queries. Preparation of Standard operating procedures (SOP) for all the instruments, equipment and procedures. Designation - Sr. Executive/Asst. Manager Experience : 07 - 12 years Must be having experience in API
Posted 4 days ago
20.0 - 30.0 years
500 - 1000 Lacs
Hyderabad
Work from Office
Job Summary We are seeking an experienced Lead in analytical development who can plan analytical projects based on priorities and established timelines, provide timely analytical delivery for stability testing, test method development/validation, method transfers and other related requests from Research & Development (R&D) or formulation development. Roles & Responsibilities • You will have to prepare and review of technical documents e.g. stability reports, method transfer and method validation protocol and reports, etc. • You need to manage communication with stakeholders such as project leaders, product development, analytical teams and other business partners • You need to facilitate productivity improvement through proper planning of analytical activities and resource optimization • You need to co-ordinate and follow up with external labs including training of their staff. • You will need to review of analytical data for accuracy, compliance to quality requirements and completeness e.g. lab notebooks, raw data, system entries, etc. • You will have to review of technical documents such as analytical reports, method transfer /method validation protocols, reports, etc. • You will have to participate in handling and resolution of laboratory non-conformances with related documentation • You will be responsible for analytical methods and process compliance as per quality assurance requirement. Qualification Education Qualification - MSc Chemistry, MSc Food Science, B.Tech/M. Tech in Dairy Technology Minimum experience required -10 – 15 years of experience in analytical development department and must have worked on nutritional product portfolio. Skill Attributes Technical Skills • Technical expertise related to chemistry, analytical techniques, stability study assessment and advanced research technologies • Efficient in MS Office, Word/Excel/PowerPoint functionalities • Ability to interact with external labs and 3rd party manufacturing site labs to support product development team. • Ability to understand analytical methods defined by global and local bodies • Ability to resolve analytical issue associated with different product matrix. • Should be familiar with analytical methods defined by national and international bodies like Association of Official Agricultural Chemists (AOAC), Bureau of Indian Standards (BIS) etc. • Excellent knowledge of Good Laboratory Practices (GLP), Quality systems, Standard Operating Procedures, latest regulatory trends, and Global regulations as appropriate • Data review, interpretation of analytical data and accurate documentation of laboratory investigations. Behavioural Skills • Systematic approach and strategic thinking • Possess excellent interpersonal skills, communication, coordination, and time-management skills • Ability to independently handle teams • Excellent oral/written communication and articulation skills • Passion for people development • Ability to prioritize work and change focus quickly • Ability to delegate effectively Additional Information About the Department Global Generics India Global Generics India business journey began in 1986. In the last three decades, we have grown as a trusted name in the healthcare industry and rank as one of the top 10 Pharma Companies in the Indian Pharma Market (IPM) as per IQVIA MAT (November 2022). Our commitment to Lead Ahead has helped us move ranks from 16th position to 10th position (IPM) in the last four years. We are a fast-growing organisation with double-digit growth and significant market share in domestic markets. Currently, we rank among the top 5 in oncology, anti-allergy and gastrointestinal diseases and the top 10 in a few other therapy areas. Our focus is on leveraging our digital capabilities, collaborations, innovations and inorganic opportunities to become the top 5 companies in the Indian Pharma Market. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/
Posted 6 days ago
2.0 - 7.0 years
4 - 6 Lacs
Bharuch, Ahmedabad, Vadodara
Work from Office
Preparing test solutions, compounds, and reagents for conducting tests and advising and coordinating test procedures. (qualitative and quantitative chemical and collect/physical analysis of raw materials, finished products and/or stability samples Required Candidate profile 6+ yrs of Agrochemicals/chemicals in Green field/brown field Projects Exp in handling instruments like UPLC, LC-MS , GC, ICP-OES, XRD & DSC capitalplacement04@gmail.com P- 9315507817
Posted 1 week ago
4.0 - 6.0 years
3 - 5 Lacs
Bengaluru
Work from Office
Understanding business of bioprocessing technologies, clone development, upstream and downstream processing, assay biology, and characterization techniques Understand the analytical requirements of Biologics, Biosimilars, Vaccines, fusion proteins Required Candidate profile Desirable: 10 years in Business Development for services in CRO/CDMO working in Biopharma space specially in analytical development.communication, negotiation, and presentation skills
Posted 1 week ago
1.0 - 4.0 years
2 - 4 Lacs
Navi Mumbai
Work from Office
Role & responsibilities Must have experience in Analytical Method Development. Must have Analytical Method Validation Handling HPLC Apply only API background candidate Preferred candidate profile Male candidate preferred
Posted 1 week ago
7.0 - 12.0 years
35 - 50 Lacs
Hyderabad
Work from Office
Job Summary We are seeking an experienced analytical development scientist who can plan analytical projects based on priorities and established timelines, provide timely analytical delivery for test method development/validation, method transfers, stability testing and other related requests from Nutraceutical product development. Roles & Responsibilities You will have to prepare and review of technical documents e.g. stability reports, method transfer and method validation protocol and reports, etc. You need to manage communication with stakeholders such as project leaders, product development, analytical teams and other business partners You need to facilitate productivity improvement through proper planning of analytical activities and resource optimization You need to co-ordinate and follow up with external labs including training of their staff. You will need to review of analytical data for accuracy, compliance to quality requirements and completeness e.g. lab notebooks, raw data, system entries, etc. You will have to review of technical documents such as analytical reports, method transfer /method validation protocols, reports, etc. You will have to participate in handling and resolution of laboratory non-conformances with related documentation You will be responsible for analytical methods and process compliance as per quality assurance requirement in including QMS. You will be responsible to establish shelf life of products by statistical methods and preparation of shelf life assessment documents. Manage lab always in compliant status and responsible for calibration and maintenance of equipments. Qualification Education Qualification - MSc Chemistry, MSc Food Science, B.Tech/M. Tech in Dairy Technology Minimum experience required -10 – 15 years of experience in analytical development department and must have worked on nutritional product portfolio. Skill Attributes Technical Skills Technical expertise related to chemistry, analytical techniques, stability study assessment and advanced research technologies Efficient in MS Office, Word/Excel/PowerPoint functionalities Ability to interact with external labs and 3rd party manufacturing site labs to support product development team. Ability to understand analytical methods defined by global and local bodies and prepares internal STP for different products. Ability to resolve analytical issue associated with different product matrix. Good understanding and working experience of analytical equipments like HPLC, LC-MS/MS, ICP-OES, ICP-MS, Mozonnier, Kjeldahl etc. Good knowledge and working experience in proximate analysis and quantification of Vitamins and Minerals in nutrition products with complex matrix. Can handle equipment individually and train other scientists and third party staff. Should be familiar with analytical methods defined by national and international bodies like Association of Official Agricultural Chemists (AOAC), Bureau of Indian Standards (BIS) etc. Excellent knowledge of Good Laboratory Practices (GLP), Quality systems, Standard Operating Procedures, latest regulatory trends, and Global regulations as appropriate Data review, interpretation of analytical data and accurate documentation of laboratory investigations. Behavioural Skills Systematic approach and strategic thinking Possess excellent interpersonal skills, communication, coordination, and time-management skills Ability to independently handle teams and experiments Excellent oral/written communication and articulation skills Ability to prioritize work and change focus quickly Additional Information About the Department Global Generics India Global Generics India business journey began in 1986. In the last three decades, we have grown as a trusted name in the healthcare industry and rank as one of the top 10 Pharma Companies in the Indian Pharma Market (IPM) as per IQVIA MAT (November 2022). Our commitment to Lead Ahead has helped us move ranks from 16th position to 10th position (IPM) in the last four years. We are a fast-growing organisation with double-digit growth and significant market share in domestic markets. Currently, we rank among the top 5 in oncology, anti-allergy and gastrointestinal diseases and the top 10 in a few other therapy areas. Our focus is on leveraging our digital capabilities, collaborations, innovations and inorganic opportunities to become the top 5 companies in the Indian Pharma Market. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/
Posted 1 week ago
2.0 - 4.0 years
3 - 3 Lacs
Mumbai, Govandi
Work from Office
Key Responsibilities: Develop and validate analytical methods using HPLC, UV, IR, and GC. Prepare protocols and reports for method development and validation. Perform stability studies and sample analysis for new products. Maintain instruments and lab notebooks as per SOPs and GMP guidelines. Coordinate with formulation development and QA teams. Requirements: M.Sc. / B.Pharm / M.Pharm in Chemistry/Pharmaceutical Sciences. Knowledge of ICH guidelines and regulatory documentation. Hands-on experience with chromatographic techniques and software. Analytical Method Development of Assay, Related Substances, Residual Solvents & Dissolution Test Methods with Literature Search & Report.
Posted 1 week ago
2.0 - 3.0 years
2 - 4 Lacs
Bidar
Work from Office
We are seeking a skilled and detail-oriented Analytical FR&D Executive to join our Formulation Research & Development team. The ideal candidate will have hands-on experience in analytical method development, validation, and routine analysis supporting formulation projects. This is a critical role that ensures product quality, compliance, and supports regulatory filings for both domestic and international markets. Key Responsibilities: Conduct analytical method development and validation for finished pharmaceutical dosage forms (solid, liquid, semi-solid) Perform routine analysis of stability and development samples as per ICH guidelines Prepare and review analytical documentation , including method validation protocols, SOPs, and reports Support formulation teams by providing timely and accurate analytical data Handle instruments such as HPLC, UV-Vis Spectrophotometer, FTIR, Dissolution Tester, GC, etc. Ensure adherence to GLP , GMP , and data integrity practices in the laboratory Coordinate with cross-functional teams including formulation, QA, and RA during product development and scale-up Support in compiling data for regulatory submissions (ANDA, CTD, Dossier, etc.)
Posted 2 weeks ago
5.0 - 6.0 years
4 - 5 Lacs
Roha
Work from Office
Knowledge of Method Validation & verification as per Pharmacopiea requirement. To perform Method Validation & verification of Chromatographic GC / HPLC methods. Preparation of specification in DMS & SAP system. SOP preparation related to AMD work. Required Candidate profile Candidate Must be MSc Regular. AMD protocols & report preparation, non-chromatographic methods. Maintain require stds & Impurities stock, list etc. Operation of instruments like HPLC,GC,UV,IR etc.
Posted 2 weeks ago
5.0 - 6.0 years
4 - 5 Lacs
Roha
Work from Office
Knowledge of Method Validation & verification as per Pharmacopiea requirement. To perform Method Validation & verification of Chromatographic GC / HPLC methods. Preparation of specification in DMS & SAP system. SOP preparation related to AMD work. Required Candidate profile Candidate Must be MSc Regular. AMD protocols & report preparation, non-chromatographic methods. Maintain require stds & Impurities stock, list etc. Operation of instruments like HPLC,GC,UV,IR etc.
Posted 2 weeks ago
2.0 - 7.0 years
3 - 8 Lacs
Bhiwadi
Work from Office
Roles and Responsibilities Develop analytical methods for different dosages form using techniques such as HPLC, GC, UV-Vis Spectrometer, Ion Chromatography, etc. Validate developed methods according to cGMP guidelines and company SOPs. Conduct method transfer activities to ensure successful implementation of new methods at different sites. Collaborate with cross-functional teams to resolve method-related issues and improve overall process efficiency. Maintain accurate records of all experiments, results, and reports in accordance with regulatory requirements. Desired Candidate Profile MS/M.Sc (Science) degree in Chemistry or related field from a recognized university. 2-7 years of experience in Analytical Research & Development (AR&D) industry. Strong knowledge of Analytical Method Development, Method Validation, and Analytical Development principles.
Posted 2 weeks ago
5.0 - 8.0 years
7 - 10 Lacs
Hyderabad
Work from Office
What you will do Let’s do this. Let’s change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Potential to oversee or manage staff Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, postmarket supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR Master’s degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Experience managing or overing staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Posted 3 weeks ago
4.0 - 9.0 years
5 - 9 Lacs
Pune
Work from Office
We are seeking a CRMA Sr. Developer with a strong technical background and extensive understanding and experience in database and analytical tools to join our team. This role offers the opportunity to work with cutting-edge analytics tools like Tableau CRM and Einstein Analytics and make an impact on our data-driven journey. Key Responsibilities: Data Analysis and Insights: o Utilize Tableau CRM and Einstein Analytics to identify unexpected business outcomes and perform in-depth analysis. o Experience with other business intelligence (BI), extract-transform-load (ETL), Power BI and other business analytics reporting tools. Technical Support: o Provide expert support in Tableau CRM, Einstein AI, and analytics tools to ensure optimal utilization within the organization. Data Design and Analysis Techniques: o Employ data cleansing, statistical analysis, data mining, predictive analysis, and other data analysis techniques to extract valuable insights from extensive datasets. o Design and configure highly scalable solutions for clients. Research and Recommendations: o Conduct research and offer recommendations on product components, services, protocols, and standards to enhance data analytics capabilities. Data Transformation and Visualization: o Collaborate in the design of data transformation processes, data flows, and datasets. o Create dashboard wireframes and stories to communicate data insights effectively. o Use methods like data cleansing, statistics, data mining, predictive analysis, and other data analysis techniques to collect and extract insights from large scale data sets. Required Skills: Salesforce ExpertiseA strong foundation in Salesforce development is essential. Proficiency in Salesforce platform features, data modeling, and configuration is a must. Platform ExperienceA minimum of 4 years of hands-on experience working with Salesforce Einstein Analytics and Tableau CRM. Einstein DiscoveryProfound understanding of Einstein Discovery from both a functional and technical perspective. Analytical Skills: Strong experience in data analysis with the ability to identify trends and create visualizations with extensive datasets. Business AlignmentDemonstrated ability to align data analytics with business objectives, envision solutions to address business problems, and derive value from data. Scalable SolutionsExperience in building and configuring highly scalable solutions for clients. Proof of ConceptsCapable of creating and delivering hands-on technology proof of concepts. Database UnderstandingStrong conceptual understanding and hands on working experience in relational databases, data warehouses, data lakes, and must have good skills in SQL, normalization, and data modeling. Communication Skills: Effective communication skills to collaborate with clients, team members, and stakeholders, including the ability to translate business requirements into technical solutions. Problem-SolvingStrong problem-solving abilities to address complex business challenges and optimize processes. Qualifications: Bachelor's degree in computer science, Information Technology, or related field. 4+ years of experience as Salesforce Eninstein Analytics Developer. Certification in Tableau CRM and Einstein Discovery Consultant is highly required and Sales Cloud. Strong communication skills to articulate technical concepts to non-technical stakeholders.
Posted 3 weeks ago
3.0 - 5.0 years
3 - 4 Lacs
Khambhat
Work from Office
* Expertise in Analytical Method development for RM, FP, APIs and intermediates * To be performed method validation, preparation of protocols and reports * Expertise on Handling and maintenance of lab Instruments like HPLC GC KF MP Required Candidate profile * Perform wet analysis like KF Titration LOD ROI etc * Lab instrument calibration & SOP Preparation * Coordinate with R&D Team & planning management
Posted 4 weeks ago
2.0 - 6.0 years
6 - 10 Lacs
Mumbai
Work from Office
Literature survey for assigned projects. Analysis of innovator samples as and when provided. Preparation of test report against the Test request form received and compilation of results if necessary. Analytical method development of drug substances and drug products. Validation of drug products and verifications on activities for drug substances. To act as instrument in-charge for the allotted instruments and responsible for calibration and maintenance of the same. Carry out basic trouble shooting for instrument related issue, whenever required. ll Impart training with respect to instrument handling to junior colleagues. Preparation and checking ofMDR, MVR and MOA. Maintain GLP Activity in Laboratories. To participate in method transfer, critical analysis activity at plant or outside testing laboratories Analysis of development batches and stability batches. Writing of experiments online in Laboratory Notebooks (LNB) with all details. Processing of raw data and calculations after completion of each analysis.
Posted 4 weeks ago
5.0 - 7.0 years
6 - 10 Lacs
Ahmedabad
Work from Office
Responsible to prepare analytical method development, development validation, method transfer protocol and reports. Perform F&D Trial sample analysis, Wet analysis and stability sample analysis with proper data complication. Operation of machine and instrument like HPLC(Make = Shimadzu,Thermo Software =Chromeleon, Lab solution,LC Solution), UV spectrometer (Make = Shimadzu, Software = Lab Solution), IR (Make = Shimadzu, Software = Lab Solution) Dissolution apparatuses, Liquid partical counter and Karl fischer for water content. Perform instrument calibration as per respective SOP daily pH meter calibration and balance verification.
Posted 4 weeks ago
2.0 - 4.0 years
7 - 11 Lacs
Ahmedabad
Work from Office
Literature survey for assigned projects. Analysis of innovator samples as and when provided. Analysis of development batches. Analysis of stability batches. Writing of experiments online in Laboratory Notebooks (LNB) with all details. Processing of raw data and calculations after completion of each analysis. Analytical method development of drug products. Analytical method verifications for drug substances. Preparation of Specifications-STP for Raw materials and finished products.
Posted 4 weeks ago
1.0 - 6.0 years
1 - 4 Lacs
Mumbai, Mumbai Suburban, Mumbai (All Areas)
Work from Office
Operation and Calibration of Analytical Balance Method Development Method Validation Scale up Batch Analysis, Investigating Analysis HPLC Analysis Instruments handling
Posted 1 month ago
2.0 - 7.0 years
1 - 5 Lacs
Mohali, Chandigarh, Panchkula
Work from Office
Role & responsibilities Preparation and Standardization of Reagents and Solutions Testing of Reference Materials (ISO/IEC 17025 & ISO 17034 Compliance) Operation and Calibration of Analytical Instruments Qualification of Working Standards and Method Validation Compliance with Standard Operating Procedures (SOPs) Sample Analysis and Method Development Instrument and Software Qualification Analytical Documentation and Logbook Maintenance Environmental Monitoring and Data Recording OOS, Deviation, and Incident Investigation Analytical Protocol and Report Preparation Training Record Maintenance General Laboratory Support and Assigned Tasks Preferred candidate profile Educational Qualification: Masters degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline. Experience: 2 - 8 years of hands-on experience in a Quality Control (QC) or Analytical Development Laboratories. Experience working in an ISO/IEC 17025 and/or GMP-regulated environment is highly desirable.
Posted 1 month ago
10.0 - 17.0 years
10 - 20 Lacs
Hyderabad
Work from Office
Job Summary We are seeking an experienced Lead in analytical development who can plan analytical projects based on priorities and established timelines, provide timely analytical delivery for stability testing, test method development/validation, method transfers and other related requests from Research & Development (R&D) or formulation development. Roles & Responsibilities • You will have to prepare and review of technical documents e.g. stability reports, method transfer and method validation protocol and reports, etc. • You need to manage communication with stakeholders such as project leaders, product development, analytical teams and other business partners • You need to facilitate productivity improvement through proper planning of analytical activities and resource optimization • You need to co-ordinate and follow up with external labs including training of their staff. • You will need to review of analytical data for accuracy, compliance to quality requirements and completeness e.g. lab notebooks, raw data, system entries, etc. • You will have to review of technical documents such as analytical reports, method transfer /method validation protocols, reports, etc. • You will have to participate in handling and resolution of laboratory non-conformances with related documentation • You will be responsible for analytical methods and process compliance as per quality assurance requirement. Education Qualification - MSc Chemistry, MSc Food Science, B.Tech/M. Tech in Dairy Technology Minimum experience required -10 15 years of experience in analytical development department and must have worked on nutritional product portfolio. Skill Attributes Technical Skills • Technical expertise related to chemistry, analytical techniques, stability study assessment and advanced research technologies • Efficient in MS Office, Word/Excel/PowerPoint functionalities • Ability to interact with external labs and 3rd party manufacturing site labs to support product development team. • Ability to understand analytical methods defined by global and local bodies • Ability to resolve analytical issue associated with different product matrix. • Should be familiar with analytical methods defined by national and international bodies like Association of Official Agricultural Chemists (AOAC), Bureau of Indian Standards (BIS) etc. • Excellent knowledge of Good Laboratory Practices (GLP), Quality systems, Standard Operating Procedures, latest regulatory trends, and Global regulations as appropriate • Data review, interpretation of analytical data and accurate documentation of laboratory investigations. Behavioural Skills • Systematic approach and strategic thinking • Possess excellent interpersonal skills, communication, coordination, and time-management skills • Ability to independently handle teams • Excellent oral/written communication and articulation skills • Passion for people development • Ability to prioritize work and change focus quickly • Ability to delegate effectively
Posted 1 month ago
8.0 - 12.0 years
15 - 18 Lacs
Hyderabad
Work from Office
Day to day analytical activities for robust method development for peptide molecules by different techniques (HPLC and GC).Preparation of Analytical Developments Validation Protocol, process scale-up,validation of methods.Interact with customes. Required Candidate profile 10 years of experience in Analytical R&D in Peptide analytical method development, peptide characterization. Worked on Biotechnology, Chemical peptides and proteins related science.
Posted 1 month ago
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