29 Method Transfer Jobs

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.

Role & responsibilities : Routine analysis & Stability Analysis (assay, RS, dissolution, water content etc.) of R&D formulation projects (solid & liquid orals, injectables) Daily calibration of pH meters, balances etc. Stability sample management (loading & withdrawal as per stability plan) Preparation of Stability Reports & other protocol based study reports for assigned projects, as applicable Hands-on experience of analytical instrumental techniques (HPLC with chromatographic software etc.) Assisting analytical method development/validation/method transfer activities, as per need Supporting other assigned lab responsibilities for GLP compliance Preferred candidate profile

We have opening for Formulation AR&D Department. Job Openings: 6 Nos Position : Research Analyst or Sr Research Analyst Handling Instruments like HPLC 1-5 Years Exp 2- 8 Yrs. Job Location: Pashamylaram - Patancheruv (Telangana) Salary : As Per Company Norms Qualification: Pharm or M.Sc. or M .Pharm Job Description 1) Method Development and routine analysis of Assay, Dissolution, Related substances, Content Uniformity, Blend Uniformity. 2) Responsible for Analytical Method Validation activities for solid orals and injectables. 3) Responsible for Routine and Stability analysis activities for solid orals and injectables. 4)Responsible for the Review of documents generated in Method development activity. 5)Responsible for the Preparation and Review of Tentative method of analysis and Method development Reports. Ref to Friends or colleagues. Please share me update resume: careers@biophore.com Total Exp : Current CTC: Exp CTC: Notice Period: Current Designation:

Strong Online Testing & Analysis knowledge Strong Sampling & Methodology knowledge Instrument Calibration & Validation Documentation & Label Method Development & Validation Strong SOP & QMS Compliance Candidates from Herbal/Phyto industry is required

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.

Department: Analytical Development Injectables / Complex Injectables US Market Job Description: Method Development of Drug Product and Method verification of Raw Materials using HPLC, UHPLC with sound knowledge of Chromeleon & Lab solution software. To perform analysis of Drug Product and Drug Substances for various test parameters and as per the product development requirement. Compilation of analytical results and preparation Method Development Report. Literature survey to support method development of Drug product and characterization activity of Drug product. Compilation and monitoring of routine and stability analysis data. Support to formulation team to develop the drug product.

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.

Method development & Validation ( HPLC /GC/ UV/ Potentiometer etc..) for both Solid orals and Injectables & Handling of all analytical instruments/ Equipments, SOPs prepation, SPEC and STPs prepation/ review,Stability samples analysis .

Overview Monitor market category, customer and competitor performance across key AMESA markets and execute scorecard reporting for top customers at required intervals and generate scorecards and performance overviews (quarterly/adhoc for key customers) for the categories and customers Leverage multiple data sources (Nielsen/IRI, Household panel data, Customer scan/loyalty data) and market/customer understanding, to support AMESA DX Supports in the creation and driving of winning execution strategies in-store with customers. Identifies sales opportunities and optimization tactics to drive category demand, space and shopper KPIs Analyze and prepare reports on Promotions and NPD performance and benchmarking in external views (Nielsen, dunnhumby etc.) to measure and optimize, to drive category growth Able to collaborate and work with BU teams and external third party agencies to acquire information and resolve any service issues on projects Responsibilities Ability to work in diverse teams Language skills English business fluent Possess ability to analyze & benchmark competitive scenarios Excellent written and oral communication skills; consistently communicates using appropriate methods for situation and audience in clear, concise and professional manner Ability to work collaboratively and proactively with multi-functional teams Be flexible, organized and able to handle competing priorities Qualifications Bachelors' degree in Business, Marketing, EngineeringMBA a plus 4yrs+ insights/ analytics Prior FMCG experience Knowledge of Nielsen, Household Panel, dunnhumby Advanced Microsoft Office / PowerPoint & Excel skills Can synthesize multiple disparate data sources into compelling growth strategies/reviews Can easily see how insights and research learnings can improve business and frames up reporting efforts and opportunities to inform business decisions

For day to day sample extractions & instrument (LCMS/MS - GCMS/MS) sequencing Roles and Responsibilities Testing of various agriculture and food products for chemical and nutritional testing by standard and in-house methods Hands on expireance in Proximate Analysis Operating the lab instruments like pH meter, weighing balance, incubator, GCMS/MS & LCMS/MS, UPLC Preparation of standard solutions Daily maintenance of lab equipment. Following good laboratory practices Following disposal process for samples & solutions as per SOP. Accurate analysis and interpretation of test results Maintenance of laboratory documents and records Validation of methods and calibration/verification of instruments Ensuring purity and validity of CRMs Conduct sensory evaluations of food samples

Role & responsibilities USFDA Experience Production Process Knowledge & Risk Assessment Method Transfer & Scale up from F&D (Dispensing, Mixing, Filtration, Filling, Sterilizer, Inspection, Packing) Aware of QMS Tools applicable on Production process Capable of doing investigations, Root cause & CAPA management.

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

Follow- GLP/ GDP/Preparation-Perform AMV & AMD/ Verification protocol & Report/ Calibration of Instrument & Equipments/Support Process Development team/Development of using Analytical instrumentation technique/ Develop method of impurity isolation Required Candidate profile Review & execute-Specification/STP/SOP/calibration documents/Routine samples( Sample for process development, IPQC, complete analysis/stability samples/outside samples/Supporting for TTD/ GC/ HPLC

Responsible for testing of Raw material,IP/ FP and Stability sample as per method of analysis Should have knowledge for the Method Verification/validation and Method Transfer analysis Have an exposure on operation, calibration, Qualification and maintenance of laboratory instruments / equipments. Have an exposure for the preparation of calibration & PM schedule of laboratory instruments / equipments. Should have knowledge for the preparation, handling & management of working/reference standards etc. Testing of In-process, stability and Finished product samples Should have awareness of Caliber LIMS system operation.