48 Method Transfer Jobs

You will be joining our team as a Deputy Manager/Manager, Analytical method transfer, responsible for delivering developed analytical assays from R&D scale to GMP-compliant commercial quality control labs. Your role will involve overseeing projects related to analytical method transfer, collaborating with cross-functional teams, and ensuring technology transfer and assays qualification activities are conducted in compliance with GLP and GMP standards. The ideal candidate will possess expertise in cGMP, regulatory requirements, technical troubleshooting, method transfer, method validation, technology transfer, and laboratory techniques to support routine testing and release of research and cGMP grade materials. You will be directly involved in drafting technology transfer documents, risk assessments, process FMEA, method validation protocols, facility fit assessments, and other related activities necessary for the release and testing of microbial and mammalian fermentation-based products. You should have familiarity with analytical assays such as HPLC, GC, SDS-PAGE, agarose gel electrophoresis, densitometry, dd-PCR, RT-PCR, ELISA, UV-Visible spectrophotometry, western-Blot, as well as microbiological techniques like BET, BioBioburdend Sterility testing. Additionally, the position may entail assisting in cell bank testing and release under cGMP regulations and coordinating with third-party collaborators for external testing as needed. Your responsibilities will also include authoring and reviewing research studies, compiling experimental data, and contributing to protocols, study reports, and publications with minimal supervision. You will work as part of the method transfer and method validation team, ensuring timely and successful completion of process transfers while addressing any unexpected technical challenges. We are looking for individuals who are enthusiastic, highly motivated, and capable of multitasking. The role requires working collaboratively within a team environment and independently across various aspects of projects related to microbial-derived products.,

Division Department Sub Department 1 Job Purpose Provide analytical support to API R&D, Regulatory Affairs, Manufacturing units and other analytical laboratories by method development of raw materials, intermediates and final API in order to ensure the drug development is carried out as per the project timelines and adheres to all regulatory requirements Key Accountabilities (1/6) Provide method development and routine analysis under GLP environment to finalise the specification for standardization of the molecule and for final DMF submission Conduct extensive literature search Analyse raw materials, intermediates, final API, forced degradation samples, stability samples, GTIs on different analytical instruments under GLP environment Conduct Fate and Purge studies/carryover studies Perform method validation Prepare specification based on carryover studies Perform method transfer to manufacturing units for routine QC analysis Key Accountabilities (2/6) Investigate plant queries like OOS, OOT for quality control of drug substance and products in order to provide corrective actions and check samples for impurities Review the entire process to identify the source of impurities Perform degradation study to identify impurities Analyse packing material in case of leachable and extractable Key Accountabilities (3/6) Characterise final API and impurities to prepare the test or working standards for routine laboratory purpose Perform chemical and physicochemical analysis to arrive at the purity, potency and structural identity of the molecule Store impurities as per chemical properties Key Accountabilities (4/6) Conduct the incubation and perform complete analysis of stability samples to conclude the storage, shelf life and packing conditions of the final API Incubate samples at various conditions Select packing material Perform analysis of stability samples Compile trend and identify degrading impurity Evaluate shelf life of the drug substance for expiry conclusion Key Accountabilities (5/6) Keep track of the latest innovation and applications which can be used with the existing techniques to investigate / resolve critical issues Attend various webinars, conferences Evaluate various demo datas generated by instrument manufacturers at their demo labs Compare various parameters like shorter run time, solvent consumption, cost factor and environment safety Key Accountabilities (6/6) Major Challenges Changes in the Regulatory guidelines: Keeping abreast with latest regulatory guidelines and interaction with RA department Conflict regarding the priorities of samples: Interaction with cross-functional team along with the managers to prioritise the samples Delay in cross-functional activities: Interaction with immediate supervisor for clarity of responsibility Difference in instrument compatibility for analysis: Escalated to supervisors Key Interactions (1/2) API R&D/ F R & D for planning, product information and result discussion (daily) RA for regulatory discussion for Deficiency, DMF filing (as per need basis) IP or patenting any product or getting information of any known patent (as per need basis) Units for sample requirement, Method transfer, Method validations, investigations (weekly) Purchase & Imports for impurities/chemicals, instrument and Equipment (as per need basis) HR for Personal discussion and organisation rules and regulation, company policy discussion (as per need basis) Key Interactions (2/2) Outsource Labsfor external analysis (weekly) Vendors-Instruments/Equipment for service and support (as per need basis) Application specialists for application support to resolve any challenging queries (as per need basis) Dimensions (1/2) Minimal error for lab compliance and maximise output Maximise instrument utility by working in shifts Online delivery of analytical data to R&D Ensuring 100% compliance with the regulatory Meet the turnaround times for projects Publish two papers in a year Dimensions (2/2) Number of trials on various techniques during development stages Key Decisions (1/2) Result discussion for online monitoring of samples with R&D Change in method of analysis with supporting analytical data to the respective Group Leader Key Decisions (2/2) Education Qualification Sc Relevant Work Experience Minimum 15 years of experience in pharmaceutical industry with analytical experience Good presentation and communication skills are preferable Show

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

Hiring - ADL (AMD) - Nagpur Location Location - Nagpur MH Company - Pharma (MNC) Core OSD Formulation + Method Validation Experience Msc or Mpharm /bpharma Responsibility - Sr. Role Description 1. Analytical Method Development New analytical method development and troubleshooting of existing method of different types of Oral solids dosage form (Granules, Tablets, Pellets, Capsules etc.) for Regulated market projects or as per business need. 1. Ensure robust & cost effective method development of product by considering the available facility & resources 2. Conduct Literature survey, different pharmacopoeia & pharmacopeia forum search and review & application of same in AMD. 3. Conduct Pre-formulation studies (API characterization and Drug-Excipients compatibility studies). 4. Operation and calibration of different analytical instruments. 5. Take into account existing QC facility while developing any product for successful method transfer. 6. Analytical method validation and method transfer activity. 7. Maintain the Good Laboratory practices, Good Documentation practice and Good hygiene practices. 8. Prepare for all type of internal and external audit/inspection. 2. Stability Studies of R&D Products 1. Responsible for stability studies of new R & D products for Regulated market projects. 2. Responsible for interpretation of stability data of the products related to analytical methods. 3. Observations of stability trend and discussion of same with formulation team. 4. Management of stability batches analysis and take the decision for stability studies of different batches as per requirement. 3. Routine Support to F&D Team 1. Responsible for providing routine support for the new product development for regulated market projects. 2. Planning and execution of routine batches analysis in minimum possible time. 3. Analytical data review and to provide the online results and observations to F&D Team. 4. GLP, GDP and Documentation Support 1. Responsible for maintaining the overall GLP and GDP in the Laboratory and providing overall GLP support during day to day activities. 2. Maintenance of working standards, Impurities and reference standards 3. Responsible for preparation, review and approvals of all the documents generating in the ARDL laboratory. 5. Team Building 1. Ensure continuous training and up-gradation of knowledge of the R&D team so that they are at the cutting edge of technology. 2. Set challenging goals for team members to ensure they deliver as per their true potential & as per the need of organization. 3. Identify & nurture the top talent of team. 4. Arrange a monthly interaction with team members to understand & resolve their performance bottle necks & also give them feedback for course correction. Performing any other responsibility as per the requirement, in the larger interest of organization. Interested!!!Please share your cv at Neetij@selectsourceintl.com Thanks & Regards

Job Title: Scientist / Sr. Scientist API R&D Department: Research & Development Location: Kolkata Key Responsibilities: Analytical Method Development: Develop and validate robust analytical methods (HPLC, GC, LC-MS, UV, FTIR, etc.) for quantification, purity, stability, and impurity profiling of APIs (maintaining GLP) Method Validation and Verification: Conducting studies to confirm that the developed methods are suitable for their intended purpose, meeting parameters like specificity, accuracy, precision, linearity, and ruggedness, Prepare and review technical documentation, including method development reports, validation protocols/reports, and regulatory submission documents. Method Transfer: Facilitating the successful transfer of analytical methods to quality control or production laboratories, ensuring reproducibility across different instruments and environments. Stability Studies: Implementing and managing API stability programs to monitor how products perform under various environmental conditions over time, ensuring continued compliance with quality standards. Regulatory and Quality Support: Providing analytical data and reports in support of regulatory filings and ongoing quality assurance requirements. Troubleshooting and Problem Solving: Using analytical expertise and state-of-the-art equipment to resolve issues, such as product failures or abnormal impurity profiles, quickly and accurately. Instrument Calibration and Maintenance: Ensuring analytical instruments are properly maintained and calibrated for reliable and reproducible results. Reference Standard Management: Handling selection, qualification, and maintenance of reference standards for ongoing quality control. Routine analysis work Qualifications & Skills: M.Sc. / M.Pharm / B.Tech/M.Tech in Analytical Chemistry, Pharmaceutical Chemistry, or related discipline. 3–8 years of relevant experience in a pharmaceutical R&D or CRO environment. Hands-on expertise in analytical instruments (HPLC, GC, UV-Vis/IR etc.). Sound understanding of ICH, USP/EP, and regulatory requirements. Proficient in data analysis, interpretation, and documentation. Strong problem-solving and communication skills; ability to work in cross-functional teams.

SENIOR QUALITY CONTROL ANALYST Job Objective: The Quality Control (QC) Analyst specializing in Method Validation and Method Development is responsible for developing, validating, and transferring analytical methods for pharmaceutical raw materials, intermediates, and finished products. The role ensures compliance with regulatory requirements and contributes to continuous improvements in analytical methodologies. Qualifications: Bachelors/Masters degree in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, or related field. Experience: More than 8 years of experience in method validation, method transfer, and regulatory compliance within a pharmaceutical QC or analytical development environment. Job Responsibilities: Method Development & Optimization: Develop and optimize analytical methods for assay, dissolution, related substances, and residual solvents using techniques like HPLC, GC, UV-Vis, FTIR. Establish and refine chromatographic conditions, mobile phases, and detection parameters for improved sensitivity and reproducibility. Conduct forced degradation and stability-indicating method development as per ICH Q1A guidelines. Method Validation & Transfer: Perform method validation as per ICH guidelines covering accuracy, precision, specificity, linearity, robustness, and system suitability. Prepare and review method validation protocols and reports. Execute method transfer activities between R&D, QC, and manufacturing sites following GMP requirements. Regulatory Compliance & Documentation: Ensure analytical methods meet US FDA, EU GMP, MHRA, WHO, and other regulatory expectations. Maintain accurate documentation as per Good Documentation Practices (GDP). Support regulatory filings by preparing analytical method validation reports and technical dossiers. Assist in responding to regulatory queries and audits related to analytical methods. Instrumentation & Troubleshooting: Operate and maintain analytical instruments such as HPLC, GC, UV-Vis, FTIR, and dissolution testers. Troubleshoot chromatographic issues related to retention time shifts, peak tailing, and resolution problems. Participate in instrument qualification (IQ/OQ/PQ) as needed. Collaboration & Process Improvement: Work closely with R&D, Manufacturing, and Quality Assurance teams for seamless method transfer. Investigate out-of-specification (OOS) and out-of-trend (OOT) results to identify root causes. Contribute to continuous improvements in analytical techniques and laboratory efficiency. Technical Skills: Strong expertise in HPLC, GC, UV-Vis, FTIR

Develop tablet/capsule formulations for regulated markets (US/EU). Conduct pre-formulation, prototype trials, and scale-up. Execute lab, exhibit, and validation batches. Prepare technical documents for ANDA filings. Support tech transfer and respond to regulatory queries.

Planning and executing assay-runs for cell based assays and ELISA as part of Method Development and Method Qualification studies Analysis of the data using parallel line analysis and equivalence testing Writing protocols and reports for Method development and Method qualification studies Maintenance of the cell lines, preparation of cell banks Review of raw data and data recording sheets and to ensure good documentation practices. Planning of day-to-day activities independently. Trouble shooting of the issues (if any) aroused during execution of assay-run. Involving in documents preparation for SOP, STP, MOA.

1) Development of mass spectrometry based methods for analysis of various molecules for pivotal studies such as biosimilarity, comparability etc.. 2)operation and maintenance of mass spectrometry instrument and performing troubleshooting activities 3)developing and carrying out multiple assays aimed at characterization of protein based therapeutics across various stage of the project 4) participate in design, development and implementation of methods for CQA/impurity characterization of molecules. Interpret results,and draw conclusions from multiple stage experiments 5) Author technical documents such as SOP,MoA,study protocol and reports for method and product development

The Junior Analyst/Executive in Analytical Research and Development (ARD) Injectables plays a vital support role in the development and evaluation of sterile pharmaceutical products This position involves performing routine analytical testing of injectable dosage forms such as solutions, lyophilized powders, emulsions, and suspensions using instruments like HPLC, UV-Vis, FTIR, pH meter, and more Under the guidance of senior scientists, the junior analyst assists in method development, validation, and stability studies, ensuring that data is accurate and meets regulatory and internal quality standards Responsibilities include sample preparation, instrument handling, maintaining laboratory notebooks, and following Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) The role also includes preparing reagents, calibrating instruments, and maintaining documentation for analytical procedures and observations Junior analysts support data compilation for regulatory submissions and assist in investigations related to analytical deviations or out-of-specification results They collaborate with cross-functional teams such as Formulation RD, QA, and Regulatory Affairs to ensure timely and compliant development activities This position requires attention to detail, a willingness to learn, and the ability to follow procedures precisely Ideal candidates should hold a Pharm, MPharm (Pharmaceutical Analysis or Pharmaceutics

Eligibility : M.Sc / M.tech (Life Sciences / Biotechnology) Technical Skills : Various Extraction Techniques Purification techniques Phytochemical Activity (Qualitative quantitative) HPLC CG AAS FTIR UV-Vis Spectrophotometer General Skills : Complete knowledge of MS Office Standardisation of SOP Sample flow management English (Reading and Writing) Candidate must have a personal Laptop

Position Title: Team Member Analytical Development Lab Department: Analytical Development Lab Location: Vadodara Reports To: Sr Manager - Analytical Development Lab Job Overview: The Team Member - Analytical supports the transfer and validation of analytical methods from R&D or third-party laboratories to manufacturing or testing environments. This role ensures smooth method transfer, compliance with regulatory standards, and effective collaboration with cross-functional teams to maintain the accuracy and reliability of testing methods. Key Responsibilities: Method Transfer Support: Assist in transferring analytical methods from R&D or third-party laboratories and setting them up on new equipment. Ensure smooth implementation of methods at the receiving site. Method Validation: Participate in the validation of analytical methods to ensure they meet standards for accuracy, precision, and reproducibility. Support the execution and documentation of validation studies. Documentation: Maintain and review method transfer and validation documentation to ensure completeness and regulatory compliance. Ensure records are accurate and ready for audits or inspections. Training: Support the training of laboratory staff on transferred methods, equipment usage, and best practices. Troubleshooting: Assist in resolving issues related to method performance or equipment functionality during the transfer process. Collaboration: Work closely with R&D, Quality Control (QC), Quality Assurance (QA), and Manufacturing teams to ensure seamless method transfer and address challenges effectively. Compliance: Ensure all transferred and validated methods comply with regulatory standards such as GMP, ICH, and other relevant guidelines. Reporting: Assist in preparing detailed reports on validation and transfer outcomes, including data analysis and findings. Key Skills: Technical Skills: Proficiency in analytical techniques such as HPLC, GC, spectroscopy, and related methods. Strong understanding of method validation principles and regulatory standards. Experience with troubleshooting analytical methods and equipment. Soft Skills: Excellent attention to detail and organizational skills. Strong communication and teamwork abilities for effective collaboration with cross-functional teams. Analytical thinking and problem-solving skills to address method transfer challenges. Qualifications & Experience: Education: Master’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field. Experience: 4-7 years of experience in analytical chemistry, method development, validation, or related fields, preferably in pharmaceutical or biotech industries.

Role & responsibilities :- 1) Knowing HPLC/ GC, Dissolution, UV, FT-IR, Potentiometer Troubleshooting, Calibration, Method Validation and Method Development. 2) Perform the analysis individually for In process and stability samples as per plan. 3) Follow Good manufacturing practices, Good laboratory practices and Good documentation practices in ADL. 4) Method Development of new products for test like Cleaning, Assay, Residual solvent, Dissolution & organic impurities. 5) Preparation, storage and usage of Volumetric / Reagent / Standard / Indicator solution. 6) Perform the calibration and verification of all instrument / equipment as per calibration scheduled. Preferred candidate profile :- Post-Graduation in M.Sc. Analytical Chemistry, Organic Chemistry From the Pharma Background Industry. Knowing GCMS, LCMS is added advantage Perks and benefits :- As per the company Policy

About Us Morepen Proprietary Drug Research Pvt. Ltd. (MPDRPL) is a dynamic pharmaceutical R&D organization committed to developing high-quality, affordable generic and novel products for global markets. With a focus on innovation and regulatory compliance, we work in the area of ANDA, NCEs, 50b2, API development and novel polymorphs. Job Roles & Responsibilities Analytical Method Development & Validation: Develop and optimize analytical methods for pharmaceutical compounds using HPLC, GC, UV-Vis, and other analytical techniques. Perform method validation studies including accuracy, precision, linearity, specificity, and robustness testing. Transfer analytical methods between laboratories and ensure successful implementation. Troubleshoot analytical methods and resolve technical issues. Sample Analysis & Testing: Conduct routine analysis of raw materials, intermediates, and finished pharmaceutical products. Perform quantitative and qualitative analysis following established protocols and regulatory guidelines. Execute stability studies and analyze samples at designated time points. Instrumentation & Maintenance: Operate and maintain analytical instruments including HPLC, GC, GC-MS, FTIR, UV-Vis spectrophotometers. Perform routine calibration. Troubleshoot instrument issues and coordinate with service technicians when needed. Ensure proper documentation of instrument performance and maintenance activities. Data Management & Reporting: Analyze and interpret analytical data using statistical methods and software. Prepare technical reports, certificates of analysis, and regulatory submissions. Maintain accurate laboratory records and electronic data systems. Knowledge & Experience Master's degree in Analytical Chemistry, Chemistry, or related field. 2 - 4 years of relevant experience in pharmaceutical, chemical, or analytical laboratory settings. Strong foundation in analytical chemistry principles and techniques. Preferred Qualifications Experience with advanced analytical techniques (DSC, TGA). Previous experience in pharmaceutical or biotech industry. Understanding of stability testing and forced degradation studies. Knowledge of cleaning validation by UV / HPLC. Why Join MPDRPL? Be part of an organization driving cost-effective global healthcare solutions . Work on end-to-end projects from concept to market. Collaborate with experts across departments in a quality-driven, innovation-centric environment . Access to modern formulation laboratories and pilot-scale facilities. Competitive compensation with performance-linked incentives . Professional development and career advancement opportunities . Comprehensive employee benefits including healthcare and retirement plans .

Department – Sales, New Generation Insulin BU Novo Nordisk India Pvt Ltd

Department – Sales, New Generation Insulin BU Novo Nordisk India Pvt Ltd

Department – Sales, New Generation Insulin BU Novo Nordisk India Pvt Ltd

Department – Sales, New Generation Insulin BU Novo Nordisk India Pvt Ltd

Department – Sales, New Generation Insulin BU Novo Nordisk India Pvt Ltd

Company Name : Paushak Limited (Alembic Group company) Position: Executive Sr. Executive (ADL) Department: Analytical Development Group Location: Halol, Vadodara Industry: Chemical / Agro Chemical / Specialty Chemicals Experience Required: 2 to 8 Years Education: M. Sc Organic Chemistry Job Responsibilities: Prepare and standardize volumetric solutions. Handle analytical instruments including HPLC, GC , and other lab equipment. Perform wet analysis, including calibration, preventive maintenance, and troubleshooting. Conduct method development for analytical procedures. Carry out stability studies for new products. Perform in-process and finished product analysis and reporting. Maintain daily analysis records and manage chemical and instrument inventories. Oversee column management, data backup, and waste management. Handle specialty chemicals with appropriate safety and analytical protocols. Skills Required: Proficiency in handling HPLC, GC , and other laboratory instruments. Strong experience in wet analysis and method development . Expertise in handling and analyzing specialty chemicals . Strong organizational skills for managing chemical stocks, instrument parts, and documentation. Familiarity with calibration protocols and stability testing.

Method Development of Assay, Dissolution and related substances, Method validation, Calibration of analytical instruments, Routine and stability samples analysis of OSD formulations, Good quality mind set and should understand GLP requirements technical report writing and power point presentation preparation. Responsibilities Qualifications M.Sc. chemistry/ pharmaceutical chemistry/ organic chemistry. Pharma ( QA, pharmaceutics)

Business: PPL Digwal Department: PTS Job Overview: To perform AR&D actives as per GMP & Safety Travel Requirements: NA Reporting Structure: Reports to Research Scientist - AR&D (Service) Key Stakeholders: Internal: QC, QA, SCM & Safety Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments. 5. API Stability knowledge. 6. Capable to handle analytical method development, Implementation, Validation as per requirement. 7. Should have experience of Analytical method transfer to QC. 8. Experience of making documents like method transfer protocol & report, method validation protocol & report, method development report, specification, standard test procedure etc. 9. Should aware about GLP practices and 21 CFR part-11. 10. Keep the work area clean and the laboratory under controlled temperature. 11. Calibrate the instruments according to the master calibration schedule and follow GLP and SOPs. 12. Understand the safety and environmental aspect. 13. Maintain the reagents and standardize the volumetric solutions as per schedule. 14. Maintain the laboratory journals and instrument log books online. 15. Ensure compliance to Hazardous waste and chemical management. Responsibilities Qualifications Qualification : M.Sc (Analytical Chemistry), (Chemistry) & (Organic Chemistry)

Under general supervision of lab team leader, independently perform routine scientific research tasks using standard techniques, procedures and equipment. Adapt and optimize or develop new methods and procedures, actively contribute to technical solution finding process. Propose solutions and discuss with manager Show engineering and tech transfer proficiency Assist and support to R & D team and cross functional team in scale-up of new products technology Troubleshoot & or improve existing processes Summarize and document results in lab journal, prepare technical reports. Maintain clean working laboratory environment and suitable working equipment. Perform general lab assignments (e.g. raw material inventory review, lab instruments ) as assigned. Comply with regulations concerning safety, health and environment

Product Specialist (Medical Representative) GLP 1 BU Prayagraj

GLP 1 BU Hyderabad