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8.0 - 13.0 years
7 - 13 Lacs
Ahmedabad
Work from Office
Position: AM_ ADL Key Requirements: Conducting in-depth Literature and patent search and making formulation development plan for Solid oral and Liquid oral formulations Develop new formulation concepts, assists in the development of project plans, business analysis and feasibility assessments. Develop experimental programs, work plan and prioritize assignments to meet project objectives within defined timelines Review and analysis of experimental data and design of further experiments. Monitoring of stability studies and Data interpretation Formula and process optimization studies - Discussion/design, review and monitoring of PET trials, pH Establishment Trials and PDR Trials Identify and manage the potential risks within projects in a timely fashion Arrange and management inventories (RM, PM, RLD etc.) required for projects. Conducting root cause analysis and trouble shooting Co-ordinate with cross functional teams for smooth flow of projects Review of technical documents like QnQ, Draft specifications, PDR report and finalization, MFR, PVP, HTSP etc. Monitoring and providing technical support for scale up and validation batches Desired qualifications: M. Pharma Desired skills: Proactive self-starter who is comfortable working independently in a fast-paced environment while maintaining attention to detail Hands on experience in formulation development of solid orals and liquid orals for regulated markets Knowledge on QbD and DoE concepts Knowledge on Regulatory guidelines for USA/Europe/ROW markets Trouble shooting and Root cause analysis skills
Posted 1 week ago
7.0 - 10.0 years
0 - 1 Lacs
Bhiwadi
Work from Office
Role & responsibilities ead formulation and development activities specifically for topical dosage forms including creams, ointments, gels, lotions, and sprays. Design and execute experiments for product development, optimization, and scale-up . Conduct pre-formulation studies , selection of excipients, and establish product design strategy. Ensure compliance with regulatory requirements for domestic and international markets (e.g., USFDA, MHRA). Coordinate with Analytical Development , Regulatory Affairs , QA/QC , and Production teams to ensure smooth technology transfer. Prepare and review technical documents like MFCs, MDDs, protocols, and development reports. Ensure documentation as per cGMP and data integrity standards. Troubleshoot formulation or process-related challenges during development or scale-up. Preferred candidate profile Strong understanding of topical formulations
Posted 3 weeks ago
8.0 - 13.0 years
10 - 13 Lacs
Bengaluru
Work from Office
Responsible for the development and dossier deliverable of genreic application for projects assigned with in the team for Europe ,Canada Australia. Preparation ,review and approval of test licenses Import license applications. Planning and procurement of RMPMs/ RLDs and inventory control at R&D for development. Preparation and review of RMPMs/Justification of Specifications/Cleaning validation report/Risk assessment report/ stability protocol/CDRs/Technology Transfer dossiers. Review of MFRs/BMRs/BPRs/PVPs/HTS, product specific questionnaire, Protocol; and report etc. for scale up and registration batches Timely and Appropriate Reponses for CMC and Bio deficiencies from regulatory agencies for filed products and review of R&D documents for regulatory and quality audits.
Posted 1 month ago
15.0 - 18.0 years
15 - 20 Lacs
Himachal Pradesh
Work from Office
Roles and Responsibilities Develop and implement new product ideas through CDSCO process. Oversee research and development projects from concept to commercialization. Collaborate with cross-functional teams to ensure successful project delivery. Ensure compliance with regulatory requirements (DCgi) and maintain high standards of quality control. Desired Candidate Profile 15-18 years of experience in pharmaceutical industry, preferably in FR&D or similar role. B.Pharma degree in Any Specialization; M.Pharma preferred but not mandatory. Strong understanding of formulation development, formulations, nutraceuticals, OSDs, and solid orals.
Posted 1 month ago
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