42 Method Transfer Jobs

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

Job Responsibilities - Lead electronic laboratory notebook (ELN) software administration and management. Provide ELN trainings to new joiners. Connect with third party and internal stakeholders on regular basis for implementation and troubleshooting. - Literature survey as per order forms. - Supervision of experimental work in laboratory. - Ensure laboratory safety and compliances - Ensure availability of raw materials and equipment required for the execution of experimental planning - Understand the safety aspects of all reactions and chemicals to be used in laboratory - Play the role of ERT and shift incharge - Perform night duties as per site philosophy -To ensure 100% compliance on ERA and zero safety incidents in lab - Laboratory management: disposal of samples, disposal of chemical waste, chemical inventory - Equipment maintenance: ensure PM of allocated instruments and inventory of spares

"1) Responsible for Laboratory execution of analytical activities on daily basis and ensuring compliance to the Safety and quality system as per cGMP. 2) Responsible for Laboratory execution of instrument calibration, stability analysis, WRS preparation/Qualification and for procurement of reference standard etc. 3) Responsible for maintaining stock of working reference standards and chemicals required routinely for raw material analysis. 4) Review and release of finished product, inprocess, intermediates, raw material, reaction monitoring results. 5) Responsible for Laboratory execution of analytical method validation/Verification and Method Transfer activites. 6) Coordination for reagents and volumetric solutions preparation, standardization and maintenance. 7) Coordination for maintaining analytical columns of HPLC, GC, IC and spare parts of instruments and Equipments. 8) Coordination of AMC / CMC of analytical laboratory instruments and its calibration. 9) Coordination for disposal of retained analytical samples of raw material, packing material, inprocess and stability samples. 10) Preparation, revision, review and checking of Raw material, inprocess, intermediates, reaction monitoring and finished products specifications and test procedure and departmental SOPs. 11) Planning and execution to review, checking of IQ, OQ and PQ documents of instruments and equipment. 12) Prepare and Review of certificate of analysis (COA) for finished products. 13) Responsible for investigation of incidents and Deviations in coordination with internal and cross functional team 14) Complying EHS promotional activities and complying EHS statutory requirements of the analytical department. 15) Handling of the ICP-MS/ ICP-OES, Ion Chromatography, GC-MS, UPLC,ION Meter and commissioning experience of the product and new Laboratory setup. "

Responsibilities: * Develop analytical methods for injectables using HPLC & GC. * Conduct method transfers, stability studies, & dissolution tests. * Validate methods through analysis & injection experiments. Health insurance Provident fund

Stedman Pharmaceuticals is looking for a dynamic and experienced candidate for the Quality Control (QC) department with hands-on experience in Analytical Method Validation for various dosage forms. Resume to hrd@stedmanpharma.com / 9786920463

Experience of reviewer data review of method validation. Document review like STP, Protocols and Reports of AMV , verification. Monitoring of daily activities Preparation and review of Validation Protocol, Report, SOP and Specifications, analysis.

Role & responsibilities :- Job overview :- The role requires strong analytical data review skills and experience with various QC instruments . The position involves supporting their North American sites , Potentially requiring the candidate to work according to US time zone. Key Responsibilities & Required Experience: Strong exposure to Analytical Data Review and electronic data review from QC instruments such as HPLC, GC, Dissolution Apparatus, and Malvern 3000 Thorough understanding of Quality Control investigations, including Lab Incidents, OOS, and OOT Preparation and Review of Method validation, Method Transfer, Method Verification and Equivalency documents, etc Review of Analytical raw data, Chromatography, and LIMS for Raw Materials/In-process/Finished Products. Preparation and Review of new SOPs. Candidates must have relevant experience in Oral Solid Dosage (OSD) formulations and/or Active Pharmaceutical Ingredient (API) processes. Kindly note the following: The selected candidate will support one of their sites in North America and will be required to work as per the US time zone . Strong communication skills are essential for this role.