175 Stability Studies Jobs - Page 3

!! Greetings from Natco Pharma Limited..!! We are conducting Walk-in Interview for Formulation Analytical Research & Development Department for our Pharma Division located at Kothur (Near to Shamshabad) Roles: Trainee /Officer / Executive / Sr. Executive / Asst. Manager Qualification: B. Pharmacy / M. Pharmacy (Pharmaceutical Analysis) / M. Sc (Analytical Chemistry) / B.Sc (Chemistry) Experience: 0 to 15 Years (Only freshers who graduated in 2024 or 2025 are eligible to attend) Skills Required: Analytical method development & validation Complex Injectable, Peptide chemistry knowledge preferred Analysis of raw materials, finished products, stability samples, Discriminatory dissolution studies, pre formulation studies, solubility studies etc Experience with instruments: LCMS, HRMS, CD, NMR, FTIR, HPLC, UPLC, GC, etc. Gender: Male only (due to shifts and oncology plant requirements) Important Notes: Only candidates with formulation experience and regulatory exposure will be considered. Candidates Interested to work in Kothur location are only requested to attend interview. Interview Date & Venue : Date: 30th August 2025 (Saturday) Time: 09:00 AM to 02:00 PM Venue: Natco House, Road No.-2, Banjara Hills, Hyderabad - 500034. (Opposite A.P. Productivity Council)

As a Research Associate at Naari Pharma, you will play a crucial role in the execution of formulation development activities for solid dosage forms across regulated and semi-regulated markets. Your responsibilities will include conducting literature search and pre-formulation studies, evaluating innovator/RLD products, executing R&D trial batches and scale-up activities, and preparing stability batches. You will also be responsible for documentation tasks such as preparing Master Formula Cards, Product Development Reports, and Stability Protocols, as well as supporting regulatory submissions. You will work closely with cross-functional teams to monitor scale-up and exhibit batches, troubleshoot formulation challenges, and ensure adherence to development timelines and project goals. The ideal candidate for this position should hold an M. Pharma degree in Pharmaceutics, have at least 3 years of hands-on experience in solid dosage formulation development, possess knowledge of pre-formulation, DoE, and scale-up activities, and be familiar with stability studies and regulatory documentation. Strong problem-solving skills, attention to detail, and good communication and teamwork abilities are also essential for this role. If you are passionate about advancing women's health through pharmaceutical innovation and are looking for an opportunity to contribute to a global company with a focus on hormonal therapies, we encourage you to apply for the Research Associate position at Naari Pharma.,

Responsible for Analysis of RM/IP/FP/PM Samples, analytical reports & documentation, identifying deviations, stability studies, comply with regulatory requirements, Calibration & trouble shooting of Instruments, Audit, cGMP & GLP, Qualifn Protocols.. Required Candidate profile B.Sc/M.Sc.with 4 to 6 yrs exp in API. Sound exp & knowledge of handling GC,HPLC, KF, IR, UV-VISUAL, Spectrophoto, AT, MP/BP etc.Legal compliance, cGMP, GLP, & regulatory guidelines (eg. ICH, USP, EP).

Roles & Responsibilities 1. To support and execute formulation development of mAbs 2. Conducting stability studies as per ICH guidelines. 3. Acquisition, recording, analysis and compilation of data in prescribed formats. 4. Responsible for maintenance and documentation of the developmental work carried out. 5. Supporting procurement/installation of appropriate equipment’s and consumables required for work, whenever applicable. 6. Capturing and compilation of the data generated contemporaneously in eLN (electronic Lab Notebook) and getting the same verified by the manager of the team regularly. 7. Ensuring proper usage and maintenance and calibration of equipment: entering the usage in log books and alerting appropriate personnel about any discrepancy and breakdown. 8. Implementation of the SHE management system in respective department/function. 9. Any other assignment given by group lead/team lead or assistance requested for compilation of urgent deliverables for the formulation development team. Additional Responsibilities: 1. Collection and review of the related literatures for specific methods/molecules and participation in various other forums for discussion and presentation. 2. Ensuring good house-keeping in the laboratory Qualification Educational qualification A M. Pharm/M. S in Pharmaceutical Sciences (specialization in Pharmaceutical Biotechnology, Pharmaceutics) or M. Tech (pharmaceutical Technology/ Biotechnology) Minimum work experience 6-9 years of experience in Biological drug product formulation development, Process development Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. The World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. " Benefits Offered At Dr. Reddy’s we actively help to catalyze 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... For more details, please visit our career website at https://careers.drreddys.com/#!/ "

Development of Lyophilized Complex/Peptide Injectable & Biosimilar Product Development (Thaw, filter, fill & Finish). Drug Product R&D Stability, Compatibility & Development Studies. Participate in scale-up, toxicity/clinical exhibit batches of the Drug Products under development. Authoring regulatory filling & TTD Documents i. e. MF, RA, PDR, Stability Study Plan & R&D Stability Studies. Travel Estimate NA Job Requirements Educational Qualification M. Pharm - Pharmaceutics Experience Tenure : 2-6 years

Analyse the assigned samples and chromatographic tests for analysis by using the suitable valid procedure and calibrated instruments to ensure the compliance to the set specification / standards Perform analysis for release of RM, PM, FP & water analysis and process/cleaning validation as per commitment dates Perform analysis for stability samples without any errors as per schedule Check the results of the tests performed, evaluate them against the specifications Review the TDS printed through LIMS for its completion before release Key Accountabilities (2/6) Perform all activities as per current standard procedures by referring to all approved procedures/specifications to ensure compliance to GLP and safety norms Gather all the samples for analysis by checking the consignment for sampling Gather the essentials like standards, glassware, solvents to perform the analysis as per specification Operate the instruments and perform routine/stability as per SOP and safety norms Key Accountabilities (3/6) Document all activities performed as per valid procedure online by using standard/approved formats or templates to ensure that all entries done are correct, accurate and authentic Maintain system integrity by updating documentations and deviations on CipDox while performing operations Maintain all the online documentation and timely entries and supporting documents Prepare new documents and update existing documents as per GMP requirement Key Accountabilities (4/6) Maintain and upkeep the laboratory working area by disposing off all analysed solutions and samples after review as per valid disposal procedures to ensure compliance to GLP Maintain equipment, facility and block premises as per SOP Perform validation, qualification and calibration as per schedule and update output of all activities in the systems Key Accountabilities (5/6) Provide suggestions and ideas by exploring new possibilities to achieve cost saving and work simplification Conduct operational studies to find improvement areas and implement new development projects Strive for continuous automation of processes through implementation of new processes Key Accountabilities (6/6) Major Challenges Delay in performing analysis or re-planning due to frequent changes in production plans. Overcome by conducting performance dialogues and handshakes meetings identifying priorities Delay in performing laboratory activity due to instrument breakdown. Overcome by ensuring timely availability of parts and engineers Delay in releasing the batches due to non-availability of standards, glassware, chemicals. Overcome by coordinating with CFTs and escalations Key Interactions (1/2) Unit Planning for daily release of RM,PM and FP (Daily) Site QC (Non-Routine) for essentials of analysis (Daily) CDC for specification changes implementation (Need Basis) Unit QA for non-conformances (Need Basis) Stores for inventory (Daily)

Roles and Responsibilities Conduct analytical testing of finished products, including dissolution, UV-Vis, KF, FTIR, and GLP compliance. Develop and validate analytical methods for solid oral OSD products using techniques such as GC, HPLC, and UV spectroscopy. Perform method transfer and validation activities to ensure accuracy and reliability of test results. Collaborate with cross-functional teams to resolve OOS/OOT issues and implement corrective actions. Maintain accurate records of laboratory data, reports, and documentation in accordance with cGMP guidelines.

QA( AQA) To review the Audit Trial Report Review of SOPs pertaining to Quality Control (Chemical & Microbiology) Review of Stability protocols & Report Responsible for investigation and closure of OOL, OOT & OOS. To review the Equipment & usage log books of QC& microbiology. To review the calibration of QC & microbiology equipments Follow up for the closure of deviations/ change controls/CAPAs pertaining to QC area. To log OOS, OOT and OOLs and update the relevant databases and logbooks To Review the analytical method validation/other study Protocols, ROA and Reports Verification of Media Fill vials. Review of EMP, Water trends, specifications and testing Review of STPs & GTP materials/ Product. To prepare, review of the Quality Risk assessment documents To prepare, review of the Annual Product Quality Review (APQR) To review the Record of analysis pertaining to RM, PM, In process, validation samples and FP To review the RM, PM Sampling and it approval. only Candidates with Pharma experience/ Immediate or within 30 days joiners are requested to apply. Perks and benefits As per company standard

As a valuable member of a dynamic R&D team, you will be contributing to seamless technology transfer, innovative product development, and continuous quality enhancement for successful commercialization of pharmaceutical products across solid, semisolid, and liquid dosage forms. Your responsibilities will include leading and coordinating technology transfer from R&D/CRO to manufacturing sites, monitoring site activities, troubleshooting manufacturing issues, overseeing formulations for quality improvement, and developing new products through pre-formulation, competitor evaluation, formulation development, and stability studies. To excel in this role, you should possess expertise in technology transfer processes for multiple dosage forms, strong project management and coordination skills, the ability to handle multiple projects simultaneously, problem-solving capabilities in manufacturing environments, and proficiency in documentation, validation, and regulatory compliance. The ideal candidate will hold a M. Pharm / B. Pharm degree and have 7-10 years of experience in pharmaceutical R&D. A proven track record in technology transfer and new product development, as well as experience in solid, semisolid, and liquid dosage forms, will be advantageous for this position.,

The job involves contributing to the technical development and delivery of studies and analysis within the power systems team. This includes delivering consulting work related to various types of power systems studies and analysis such as static studies (e.g., load flow, fault level, reactive compensation), dynamic studies (e.g., stability studies), harmonic analysis, power quality, filter design, transient overvoltage, insulation coordination, control interaction studies, earthing studies, protection coordination, and Arc Flash studies. You will provide technical and project management leadership to support the project team in the successful delivery of consulting work, manage and resource the power systems team, and ensure the technical quality of delivery of power systems projects, reports, and proposals. Furthermore, you will contribute to the commercial development of studies and analysis within the power systems team by building and maintaining key client relationships, identifying areas for integration of services/skill sets through multi-disciplinary working, leading the development and delivery of project proposals, driving efficiency improvements in delivery (e.g., through the development of new scripts on power systems software packages), and ensuring excellence in power systems software packages. Other requirements for the role include leadership skills, demonstrated ability to lead and motivate a team, excellent communication skills (both verbal and written), ability to convey complex ideas clearly and concisely, strong team collaboration skills, proven experience in guiding and developing team members, being educated to degree level in Electrical Engineering with Power Systems specialization, extensive experience in power systems consulting, desire and ability to drive growth in power systems, a wide network of industry contacts and clients, proactive and highly motivated nature, proven track record in leading teams, ability to work in a fast-paced environment with multiple projects/proposals, focus on quality and excellence of deliverables, strong and in-depth market knowledge of the UK Power Industry, and proven client relationships with UK clients. If you possess these qualifications and skills, we would love to hear from you.,

As an R&D Technician, you will play a crucial role in the development of new formulations, materials, and processes while maintaining a strong focus on quality and compliance. Your responsibilities will include conducting laboratory trials, stability studies, and sample evaluations. Additionally, you will collaborate with QA/QC teams to ensure product consistency and reliability. Analyzing data from research experiments and quality assessments will be a key part of your role, providing valuable insights to inform product improvements. It will be essential to maintain accurate documentation for all R&D activities, including technical data sheets, specifications, and trial reports. Ensuring that all R&D activities align with ISO, GMP, HACCP, or other relevant quality standards is crucial. You will also be required to participate in internal audits, validations, and regulatory inspections as necessary. Providing technical support to production teams during scale-up and commercialization phases will be another important aspect of your role. In the event of quality-related issues, you will collaborate with production and quality control teams to investigate and resolve them effectively. Staying updated with industry trends, regulations, and new technologies will also be expected from you as part of this role. This is a full-time position based in Hajipur, Bihar. Relocation or reliable commuting to the workplace is preferred. The job requires in-person presence, and the application deadline is 18/08/2025, with an expected start date on the same day.,

The ideal candidate for this position will join our R&D/F&D team focusing on Oral Solid Dosage (OSD) forms, including pellets and tablets. You will be responsible for conducting pre-formulation and formulation development studies, process validation, stability studies, and technology transfer of new pharmaceutical products while ensuring adherence to ICH guidelines and internal SOPs. Your key responsibilities will include conducting detailed literature reviews to support new product development initiatives. You will evaluate reference products, patents, regulatory status, and formulation strategies. Additionally, you will perform physicochemical characterization of API and excipients, assess compatibility, solubility, and stability as part of pre-formulation studies. In the formulation development phase, you will design and develop robust formulations for tablets and pellets. You will optimize process parameters through laboratory and pilot-scale trials. Stability studies will be conducted following ICH guidelines and internal SOPs, where you will interpret results and recommend necessary formulation or process adjustments. You will coordinate and execute process validation batches in the production department, ensuring compliance with GMP and validation protocols. Technology transfer responsibilities will include preparing and reviewing complete technology transfer documentation (TTD) and facilitating successful scale-up and handover of developed products to manufacturing. In case of troubleshooting, you will provide technical support for commercialized products to resolve formulation or process issues. Documentation and record-keeping tasks will involve preparing and updating Product Development Files (PDF), Product Logbooks, and Instrument Logbooks regularly. Additionally, you will draft and review documents such as QAQN (Quality Assessment & Qualification Note), MFR (Master Formula Record), and FPS (Finished Product Specification). Qualifications required for this position include a B.Pharm/M.Pharm in Pharmaceutics or Pharmaceutical Technology and 13 years of relevant experience in F&D/R&D, preferably in OSD (tablets/pellets) formulation development in a regulated environment.,

As the Assistant General Manager for Nasal Spray Formulation Development in the Research & Development department at the R&D Center in Chinchwad, Pune, you will be responsible for leading the development of innovative nasal spray formulations. Your role will involve steering projects from concept to commercial scale-up, focusing on designing, developing, and optimizing nasal spray drug products to ensure regulatory compliance and meet quality standards. You will be leading a team of formulation scientists and collaborating with cross-functional teams to deliver high-quality, cost-effective nasal spray formulations for global markets. Your key responsibilities will include: - Developing and technology transferring Nasal Sprays, Dry Powder Inhalers, and Soft Mist Inhalers dosage forms for regulated markets like EU and US. - Preparing and reviewing literature search reports for drug substances and products, and designing product development strategies based on the findings. - Planning and guiding executives for development batches in the lab, ensuring compliance with SOPs. - Providing expert input into formulation and process studies to ensure product compliance with specifications. - Ensuring formulations and processes designed at R&D scale are capable of scale-up and technical transfer to GMP facilities. - Evaluating alternate vendors for packaging material selection and monitoring stability studies. - Preparing/reviewing Technology Transfer documents and coordinating with all stakeholders within the organization. - Following Good Laboratory Practices (GLP) & Good Manufacturing Practices (GMP) and participating in stability and validation batch manufacturing. - Preparing Product Development Reports for regulatory submission and drug product approval. You should possess the following qualifications and skills: - M.Pharm or Ph.D. in Pharmaceutics, Pharmaceutical Sciences, or a related field, with a specialization in drug delivery systems or formulation science preferred. - 8-10 years of hands-on experience in formulation development, with a minimum of 5 years focused on nasal spray or inhalation formulations. - Strong technical expertise in nasal spray formulation techniques, drug-excipient interactions, and delivery systems. - Experience in project management, working with cross-functional teams, and managing regulatory requirements. - Proven leadership abilities, excellent communication skills, and strong problem-solving capabilities. This role will require you to be primarily based at the R&D center in Pune, with occasional travel to manufacturing sites, vendors, and regulatory meetings.,

The role involves planning and resource allocation for routine operations within the analytical development function. You will be responsible for ensuring timely analysis of finished products and raw materials for various projects. Your duties will include reviewing analytical data, raw data, daily usage logbooks, and lab notebooks to support operations. You will also be involved in preparing and reviewing critical documents such as Analytical Method validation protocols, reports, method transfer protocols, and Standard Operating Procedures (SOPs). Additionally, you will conduct literature searches and provide guidance on new method development. Another key aspect of the role is to review data for stability studies and ensure timely analysis of samples. You will need to identify resource needs and initiate procurement to prevent delays in project deliverables. Supporting product technology transfers and ensuring compliance with safety measures will also be part of your responsibilities. In terms of quality management, you will be required to raise change controls, ensure data integrity, and adhere to Good Manufacturing Practices (GMP). You will also handle documentation related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and Occupational Health & Safety Assessment standards. As part of your job authority, you will review analytical data, plan and allocate resources, prepare and review SOPs, and technology transfer documents. You will also review calibration data, logbooks, and lab notebooks, as well as identify and report any near misses, hazards, or unsafe conditions. Other responsibilities include implementing QEHS policies and objectives, ensuring the use of personal protective equipment (PPE) during operations, and managing incidents and non-conformities effectively. You will also oversee work permit systems during maintenance activities and ensure proper waste disposal procedures are followed.,

Conduct final inspection and testing of finished products to ensure compliance with quality standards and customer specifications. Hands-on experience in testing of Finished products Instruments must be handled like HPLC, GC, KF, IR, DT, and Dissolution. Hands-on experience like software like Empower and LIMS. Qualification M.SC/B.Pharma 3 to 6 years Additional Information

The AGM / DGM Technical Services position requires a candidate with a B.Pharma / M.Pharma qualification and 15 to 20 years of experience in tech transfer activities of solid oral dosage forms for regulated markets. The ideal candidate should have experience in managing a team of 15 to 20 scientists, documentation officers, and technicians. As an AGM / DGM Technical Services in Kandivali, Mumbai, your responsibilities will include planning and executing scale-up and Exhibit batches of solid oral dosage forms for regulated markets such as US, EU, ROW, and Canada. You will be accountable for ensuring the timely initiation of stability studies for exhibit batches and overseeing the technical service area, specifically the Pilot batch area. Your role will involve reviewing all relevant documents for scale-up and Exhibit batches execution, such as BMR, BPR, Protocols, scale-up report, exhibit batches report, and providing filing documents to RA. You will collaborate with cross-functional teams including site manufacturing team (Production, QA, QC), R&D, RA, PDC, and Supply Chain to meet aggressive timelines for regulatory submissions and business priorities. In addition, you will be responsible for reviewing, approving, and effectively implementing change control proposals, deviations/incidents, and CAPA for scale-up and exhibit batches. Addressing deficiencies identified by regulatory agencies related to drug products and supporting the production department for validation batches and troubleshooting of commercial batches will also be part of your duties. It is essential to perform all job responsibilities in compliance with cGMP, SOPs, and other regulatory agency requirements to ensure quality and regulatory standards are met.,

As an Executive - Application Lab at Azelis India, your main objective is to develop innovation through formulation, application, sampling, and technical support in the Personal Care and Home Care products industry. You will be responsible for formulating a wide range of products, conducting stability studies, ensuring regulatory compliance, and working on sustainable product concepts aligned with market trends. Your role will also involve providing technical support to customers, conducting product demonstrations, and collaborating with suppliers on new ingredient innovations. In addition, you will manage the HPC application development lab, handle lab operations, support CAPEX planning, and maintain technical documentation. You will be required to provide internal technical training, evaluate market intelligence, develop marketing strategies, and monitor competition activities in the market. The ideal candidate for this role should have a B. Tech or M.Sc. in Chemistry/ M.Tech/Chemical Technology/cosmetologist with a minimum of 2-5 years of experience in technical/formulation development. Strong communication and collaboration skills, a sense of ownership, drive, and excellent organizational abilities are essential for this position. Fluency in English is a must, and proficiency in other languages is a plus. Adherence to work culture and ethics is also expected. Please note that the job requirements may evolve based on business needs, and you will be expected to adapt to changes and perform any tasks for which you are trained.,

You will be part of the Formulation Development team, contributing your expertise in Biologic Formulations and pharmaceutical sciences. Your responsibilities will include conducting literature reviews, formulating biological products, designing and executing experiments, analyzing data using various techniques, calibrating instruments, performing proof-of-concept studies, conducting stability studies, writing scientific reports, and collaborating with cross-functional teams. To excel in this role, you should hold a minimum of a Postgraduate degree (MTech, MPharm) in Pharmaceutical Sciences, Chemistry, or a related field. Proficiency in analytical techniques like HPLC, GC, pH, Osmolality, KF, and UV spectroscopy is essential. Effective communication, strong analytical and research skills, teamwork abilities, and knowledge of pharmaceutical excipients and raw materials will be key to your success in this position.,

You will be responsible for liaising between various departments such as Planning, Production, Technical Services, Marketing, and Exports. Your roles and responsibilities will include the preparation, review, and implementation of SOPs and STPs. You will be checking all QC related records like analytical reports and logbooks. Additionally, you will be involved in planning and distributing samples for the analysis of Raw Materials, Intermediates, and finished products. You will design and conduct Stability studies as per ICH Guidelines and develop and validate analytical testing methodology used to control raw materials, production intermediates, and final products. Your tasks will also include the preparation and maintenance of working standards with documents, as well as the operation and calibration of laboratory instruments like HPLC, GC, and Spectrophotometer. You will review and approve Raw material, finished product, and Packaging material specifications. Furthermore, you will be responsible for handling customer audits and regulatory authority audits and preparing compliance reports. Troubleshooting of HPLC, GC, and other instruments will be part of your responsibilities. You will manage the laboratory and work towards analytical laboratory improvement, cGMP and GLP compliance, and problem resolution. As the QA/QC Manager, you will be solely responsible for exports and quality-related issues for the unit. You will supervise QC chemists to ensure the smooth working of the department and to guarantee the best quality of products from the production. This is a Full Time position located in Byrathi, Bangalore.,

The Assistant General Manager - Nasal Spray Formulation Development will play a crucial role in leading the development of innovative nasal spray formulations within the Research & Development (R&D) department of a Pharmaceuticals company. Reporting to the Head of R&D, you will be responsible for driving projects from concept to commercial scale-up, ensuring regulatory compliance and meeting quality standards. Your primary focus will be on designing, developing, and optimizing nasal spray drug products for global markets. Key Responsibilities: - Develop and technology transfer Nasal Sprays, Dry Powder Inhalers, and Soft Mist Inhalers dosage forms for regulated markets like EU and US. - Conduct literature search reports for drug substances and products, design product development strategies, and propose different formulation strategies based on the review outcomes. - Guide executives in lab development batches, provide expert input into formulation and process studies, and ensure compliance with specifications. - Evaluate packaging material vendors, monitor stability studies, and prepare/review Technology Transfer documents. - Coordinate with internal stakeholders, follow GLP & GMP, participate in stability and validation batch manufacturing, and prepare PDR for regulatory submission. Qualifications & Skills: - M.Pharm or Ph.D. in Pharmaceutics, Pharmaceutical Sciences, or related field. - Specialization in drug delivery systems or formulation science preferred. Experience: - 8-10 years of formulation development experience, with a minimum of 5 years focused on nasal spray or inhalation formulations. - Proven experience in nasal spray product development from early-stage to commercial scale-up. Technical Expertise: - Strong understanding of nasal spray formulation techniques, drug-excipient interactions, and delivery systems. - Experience with device development and knowledge of regulatory requirements for nasal spray formulations. Project Management: - Strong project management skills, ability to manage multiple projects, work with cross-functional teams, and deliver results. Regulatory Knowledge: - Experience in preparing and reviewing regulatory submissions, familiarity with CMC requirements for nasal formulations. Leadership & Communication: - Ability to lead and develop a team, excellent communication and presentation skills for conveying complex scientific information. Problem-Solving & Innovation: - Strong analytical and problem-solving skills, ability to innovate and apply new technologies to improve drug delivery processes. Work Environment: - Primarily based at the R&D center with occasional travel to manufacturing sites, vendors, and regulatory meetings. Join us in this exciting role to contribute towards developing high-quality nasal spray formulations for global markets.,

Key Accountabilities Accountability Cluster Major Activities / Tasks Develop new analytical methods for analysis of routine as well as stability samples by following proper GLPs to provide results or information regarding products to formulators Perform part method validation, forced degradation studies, excipient compatibility studies, reverse engineering, add-mixture studies, in-use studies, hold-time study and analysis of routine & stability studies Conduct cleaning validation studies Perform analysis of API, excipients and secondary material (packaging material, ink, adhesive etc.) Develop cost effective & time saving analytical method for new or existing product Evaluate the pharmacopeia and verify the documents Perform maintenance and calibration of lab instruments / equipment to get accurate and reproducible analytical result for proper interpretation Maintain the lab instruments / equipment and troubleshoot the issues Perform calibration (schedule / breakdown) and calculate instrument utilisation Up-keep the HPLC/GC/IC columns as per cGLP Document and interpret the analytical data in a timely manner as per GLP / GMP requirements to maintain records and compliance of regulatory norms Record and document all analytical activities in timely manner in Lab note-book, instrument/equipment and column log book Provide base documents for MOA / COA preparation for better coordination in analytical studies Provide support to units or CFTs for transfer of analytical methods and techniques by visiting and demonstrating them with the relevant analysis to ensure successful and timely transfer of products Transfer methods and technologies to other units and departments Study the literature to resolve units and regulatory queries and conduct investigation studies in stipulated time period Analyse samples at pilot plant and unit for trace determination (Cleaning Validation) Maintain proper safety, GLP, and GMP environment in the work place to minimize accidents and incidents Follow safety guidelines by ensuring use of PPE & MSDS of chemicals at time of analysis Upkeep the samples given for analysis and ensure timely destruction after analysis as per SOP Dispose solvents and waste generated during the analysis Review the analytical requirements and recommend corrections in specifications by coordinating with units and CFTs to ensure smooth operations Arrange analytical requirements like column, impurities, standards, placebo and samples for units and other department like Validation Lab or Outsourced Lab Review and recommend corrections in the MOA, COA & Specifications Major Challenges Delay in developing analytical method due to unavailability of HPLC/ GC columns, reference impurities and specific instruments. Overcome by prior planning and by using alternate resources Additional or rework due to frequent changes in project priorities. Overcome by proper planning Key Interactions Internal External Formulation R&D for improving the quality of product (Daily) Loan Licence Team for analytical requirements which has to be provided (Weekly) Units for execution of project in unit (Twice a week) CRO for outsource analysis, validation, verification, release etc. (Twice a week) Service Engineers for breakdown of equipment and instruments (Fortnightly) Dimensions Average number of projects : 8 (FY2016-17) Average number of analytical method developed : 10 (FY2015-16) Average number of part method validation : 7 (FY2015-16) Average number of method transfers / unit queries : 2 Average number of additional projects: 4 (e.g. CIP, CHC, POC, etc.) Average number of Tec Mar studies completed : 10 per year Average number of new monographs evaluated : 10 per year Key Decisions: Decisions Recommendations Finalisation of analytical method or any change in existing method to Group/Sub-Group Leader - Formulation ADL Comments: Skills & Knowledge Educational qualifications: M. Sc. (Analytical Chemistry) / M. Pharm. Relevant experience: 2-4 years of experience in pharmaceutical organisation with knowledge of handling instruments like HPLC, GC, Dissolution tester and DPI related instruments Knowledge of current guidelines like ICH, EMEA, WHO

YOUR ROLE The Drug Products and Sciences R&D Stability team supports research and development projects for new and existing products. The Research Associate II, Stability Subject Matter Expert, applies sound chemistry and stability planning knowledge to identify and evaluate stability indicating characteristics. The effective integration of chemistry and stability enables establishment of shelf life for new or existing products manufactured for rapidly growing markets and allows for the qualification of product changes on a global scale. The Stability Subject Matter Expert designs strategies and makes recommendations that may be non-routine to address technical, regulatory, and business requirements. WHAT YOU WILL BE DOING Represent R&D Stability on project teams as a member of the project teams goals and success. Support development and implementation of stability strategies for new product development and sustaining project activities. Support development of GMP stability studies used to establish expiration dating and support labeling for product development. Contribute to the development of technical justifications for expiration dating for new or modified products and the defense of expiration dating recommendation to key business partners. Provide valuable input to stability assessments and requirements for new products and/or current product changes. Ensure the right methods and specifications are available for stability, compatibility, and release testing. Ensure that the methods are appropriate for the product design over shelf life. Demonstrate the ability to identify risks, issues, and opportunities for improvement of existing methods, technologies, and approaches. Provide sound scientific rationale. Interact with manufacturing facilities to acquire information related to test methods and specifications. Author, review and verify technical data, protocols, and reports through use of Quality Documentation System. Act as study director for stability projects under guidance of senior Stability team members. Perform stability study administration activities on LIMS including study building and review, identification of product test data requiring modification, and data entry. Support development of new and/or optimization of existing processes and procedures to enhance stability related practices. Participate in investigations that correspond to atypical, out-of-specification, or out-of-trend test results. Review data and author technical evaluations that characterize the stability trending of suspect data under guidance of senior Stability team members. Leverage critical thinking to drive the investigation to conclusions based on sound scientific principles. Contribute to stability sections intended for submission to regulatory authorities under guidance of senior Stability team members. Use computerized systems to retrieve, evaluate, summarize data for reporting. WHAT YOU WILL BRING Under guidance of senior Stability team member, able to organize complex information and demonstrate attention to detail. Logical and methodical when solving problems, developing solutions, and making sound recommendations with limited input from senior team members. Experience working with sophisticated databases. Possess relevant computer and technical skills including word processing, spreadsheets, table and graph generation, and use of databases and reporting tools. Good technical writing skills. Proficient in analytical chemistry including theoretical knowledge and practical experience. Willingness to contribute efforts beyond own scope of responsibilities to ensure project milestones are met. Basic functional understanding of FDA, ISO, and Quality systems. Works well in a team environment across multiple time zones and demonstrates an inclusive attitude. Education and/or Experience: Bachelor s Degree with 8-12 years or Master s degree with 6-10 Years in a relevant scientific subject area.

You will be responsible for reviewing R&D developmental data of ARD and PD including Method Development Reports, Method Validation Reports, Characterization Reports, Product Development Report, and Study Reports to ensure accuracy, data integrity, and compliance with systems, procedures, and regulatory requirements. Additionally, you will review Technology Transfer documents such as Method Transfer protocol/Reports, Master Formula Records, Master Packaging Record, Stability Study protocol, Specifications, and MOAs. Conducting routine laboratory rounds to ensure compliance with Good Laboratory Practices will be part of your responsibilities. You will also handle Change Controls, Deviations, Incidents, and Laboratory Assessment Reports. Preparing and reviewing SOPs, conducting SOP training, and providing training on Good Laboratory Practices to R&D personnel are also key tasks. Management of development stability samples, including protocol review, sample charging, stability calendar updation, and sample withdrawal, will fall under your purview. Other duties include handling the receipt, issuance, and management of RLDs and Exhibit batch samples, as well as issuing R&D documents like LNBs, Forms, and Logbooks for routine use. You will be responsible for maintaining the Document Archival room of R&D, issuing archived documents upon request, and managing the receipt, storage, issuance, and management of Working Standards, Reference Standards, Impurity standards, and Chromatographic columns. Additionally, you will review and approve Instrument/Equipment Qualification and calibration records. Your skills should include expertise in Quality Management systems, Good Laboratory Practices, Analytical Method Development & Validation review, Documentation Control, and Stability Studies. Intermediate proficiency is required in Product Development Report Review, Internal Quality Audits, and Review of Specification and MoAs. In addition, you should have a basic understanding of Training and advanced knowledge of USFDA, ICH, EMA Guidelines, and USP General Chapters. Qualifications: - M. Pharm. - M. Sc. (Chemistry/Biochemistry) Amneal is an equal opportunity employer that values diversity and inclusion. The Human Resources team, with its various roles including Executive, Audit, Facilitator, Consultancy, and Service, partners with all aspects of the organization to drive success through effective people management.,

: Review of R&D developmental data of ARD and PD like Method Development Reports, Method Validation Reports, Characterization Reports, Product Development Report, Study Reports, for accuracy, data integrity and compliance to systems, procedures and regulatory requirements. Review of Technology Transfer documents like Method Transfer protocol/Reports, Master Formula Records, Master Packaging Record, Stability Study protocol, Specifications and MOAs. Conducting routine laboratory rounds for ensuring compliance to Good Laboratory Practices. Handling of Change Controls, Deviations, Incidents and Laboratory Assessment Reports. Preparation, review of SOPs and conducting the SOP Training. Conducting training of R&D personnel on Good Laboratory Practices. Management of development stability samples i.e. protocol review, sample charging, stability calendar updation and sample withdrawal. Receipt, issuance and management of RLDs and Exhibit batch samples. Issuance of R&D documents like LNBs, Forms, Logbooks for routine use. Maintaining Document Archival room of R&D. Issuance of archived documents against request.Receipt of document for archival through document inward register. Receiving, storage, issuance and management of Working Standards, Reference Standards, Impurity standards and Chromatographic columns. Review and approval of Instrument/Equipment Qualification and calibration records. Skills Required: Quality Management systems | Expert Good Laboratory Practices | Advanced Analytical Method Development & Validation review | Advanced Product Development Report Review | Intermediate Internal Quality Audits | Intermediate Documentation Control | Expert Review of Specification and MoAs | Expert Stability Studies | Expert Change Control, Deviation, Incident and Laboratory Assessment Reports | Expert Training | Beginner USFDA, ICH, EMA Guidelines, USP General Chapters | Advanced

GLA University is seeking applications for two full-time Assistant Professors of Pharmaceutical Chemistry for the Institute of Pharmaceutical Research at GLA University, Mathura campus. As an Assistant Professor, you will be responsible for academic instruction, research supervision, and actively participating in departmental development. We are looking for individuals with a strong academic background, research potential, and a passion for shaping the future of pharmaceutical education. The role of Assistant Professor in Pharmaceutical Chemistry is based at GLA University, Mathura (U.P.), and is a full-time, regular position. To be eligible for this role, you must hold a B. Pharm and M. Pharm in Pharmaceutical Chemistry / Medicinal Chemistry with a First Class. Additionally, you should have a minimum of 3 years of experience in teaching, industry, or research. Preferably, you should have 12 publications in peer-reviewed journals, which would be an added advantage. Your key responsibilities as an Assistant Professor will include teaching in the D. Pharm program, covering subjects such as medicinal chemistry, pharmaceutical analysis, and pharmaceutical chemistry courses. You will be conducting research in the field, mentoring students, and contributing to the academic community through publications and presentations. Furthermore, you will contribute to curriculum development and quality enhancement initiatives, as well as promote research in synthetic chemistry, drug design, and stability studies. If you are interested in this opportunity, please apply by sharing your updated CV at vikrant.sabharwal@gla.ac.in. Join us at GLA University to be a part of our academic community and contribute to the future of pharmaceutical education. #GLAUniversity #PharmacyJobs #FacultyRecruitment #AcademicCareers #PharmaceuticalEducation #TeachingOpportunities #ResearchJobs #HigherEducationIndia #PharmaFaculty #MathuraJobs #UGCJobs #PCIApproved #PharmaCareers #HiringNow #AcademiaJobs,