7.0 - 12.0 years

0 Lacs

navi mumbai, maharashtra

On-site

You will be responsible for providing analytical support for developmental projects/comparative dissolution projects received from client sites. This includes being an interface with contract laboratories, suppliers, customers, and peers to define and improve project performance and expectations. You will coordinate with CRO to ensure that projects are completed within the timeline. Additionally, you will design scientific experiments, monitor lab work, and recommend further investigations based on experimental results. Your role will involve the preparation of test methods, technical documents, protocols, and reports when necessary. It is crucial to record information accurately, retain records and raw data properly, summarize, interpret, review data, and draw conclusions. You will analyze dissolution data sets, troubleshoot instrument or method-related problems, and adhere to GMP/safety requirements. Key interaction areas will include Drug Product development, Reg. CMC/LOC, and Spec management. Knowledge of invitro dissolution testing, comparative dissolution testing, statistical evaluation, and DoE is preferred. Familiarity with Regulatory Guidelines on dissolution studies such as FDA-SUPAC and ICH for validations and other emerging markets like China and Latin America is essential. Qualifications: - Masters in pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD) as applicable - Proficiency in English and/or other languages as required Experience: - 10-12 years of experience in the analytical field is desirable - 7-9 years of relevant industrial experience in Analytical science/Formulation science/material management and overall drug development and manufacturing process - Strong verbal, written, and presentation skills - Leadership capabilities with attention to detail and multi-tasking skills - Ability to interact and influence with various stakeholders - Experience in coaching project team members - Strong attention to deadlines and budgetary guidelines - Knowledge of medical and drug terminologies, GxPs, and worldwide regulatory requirements - Familiarity with ICH guidelines Preferred Qualifications: - Masters in Pharmacy or related science degree with 7-9 years of experience in formulation or Analytical development - Knowledge of data management systems, pharmaceutical product life cycle, and Management Information System (MIS) - Experience in DoE and statistical expertise - Diploma or certification in Regulatory Affairs Work Environment: - Office based For more information on Equal Employment Opportunity (EEO) and Accommodations, please refer to our policies.,

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Expert- Science and Technology (Oral solids formulation development) Novartis

3.0 - 8.0 years

0 Lacs

hyderabad, telangana

On-site

You will be responsible for designing, planning, performing, interpreting, and reporting the results of scientific experiments to prepare and deliver drug substances, drug products, and processes within a multifunctional project team led by a Project Leader. You will manage technical laboratory and plant activities. As a part of the Management Track, you will lead a team in developing pharmaceutical, biological, or cell-gene therapies in a small manufacturing plant environment. You will execute the functional strategy, drive operational excellence in line with TRD vision and strategy, and ensure full portfolio support in alignment with GDD, Sandoz, NTO, and NIBR plans. In the role of an Associate Scientist, you will design, plan, perform, interpret, and report scientific experiments for the development and timely delivery of drug products within a project team. Additionally, you will manage technical lab and plant activities. As a Scientist, you will be responsible for designing, planning, performing, and interpreting scientific experiments for the development and timely delivery of drug products. You will lead and manage project activities, support team members, contribute to overall strategies and goals. In the position of a Senior Scientist, you will design, plan, perform, document, and interpret scientific experiments and GMP testing or pilot plant processes for generic products. You will maintain equipment, manage operational aspects in the lab or plant, and ensure timely delivery. Key Responsibilities: - Meet quality, quantity, and timeline goals in all projects while aligning with the overall drug development process. - Plan, organize, perform, and document scientific experiments in collaboration with project teams under minimal guidance. - Provide efficient processes for specialized facilities and manufacturing operations. - Document raw data, evaluate results, propose next experiments, and optimize methods and workflows. - Generate lab procedures, reports, instructions, and SOPs, and transfer procedures to production. - Communicate problems, conduct safety searches, manage chemicals, and collaborate with team members. - Evaluate new equipment, contribute to maintenance, and ensure adherence to quality and compliance standards. - Support resource planning, quality mindset, and training compliance. - Adhere to HSE rules and guidelines, contribute to increasing efficiency, and provide measurable contributions to projects. Minimum Requirements: - B. Pharm /M. Pharm with 3-8 years of relevant experience. - Experience in safe handling of chemicals and equipment, working in interdisciplinary teams, and knowledge of SOPs and GMP regulations. - Proficiency in scientific/technical areas, laboratory tools, software, and communication skills. Join Novartis to be part of a community dedicated to helping people with diseases and their families. Collaborate, support, and inspire breakthroughs that change patients" lives. Ready to create a brighter future together ,

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