2 Scaleup Principles Jobs

As a bench scientist at our organization, you will be responsible for conducting experimentation in the field of formulation research and development for global markets. Your role will involve working with scientific principles such as Quality by Design (QbD), Design of Experiments (DoE), statistics, and scale-up principles. You will be required to analyze data from literature reviews and effectively present information for decision-making purposes. Understanding the Intellectual Property (IP) scenario and working on design strategies, prior art searches, and establishing proof of concept through experiments will be a key part of your responsibilities. You will collaborate with cross-functional teams and coordinate with various departments for technology transfer and timely execution of submission batches. Your problem-solving skills will be put to the test as you identify challenges, bottlenecks in development, and propose mitigation strategies at different stages of the development process. Prioritizing activities, conducting lab experiments, and participating in the execution of development trials will be integral to your day-to-day tasks. Aligning your activities with established milestones, ensuring clear communication with internal stakeholders, and working towards achieving Business Unit Key Performance Indicators (KPIs) are essential aspects of this role. You will also assist in evaluating business processes, identifying areas for improvement, and demonstrating personal accountability and effective work habits. Your day-to-day activities will include working closely with the formulation development teams, conducting experiments in line with QbD principles, preparing presentations at various stages of product development, and conducting literature reviews and experiment designs. You will be responsible for evaluating API & Excipients sources, conducting preformulation studies, executing development trials, and interpreting analytical data for further action plans. Additionally, you will play a crucial role in the execution of Pilot Bioequivalence (BE) batches, scale-up batches, and exhibit batches at different manufacturing locations. Your expertise in establishing stability data, preparing various documents, coordinating with cross-functional teams, and ensuring regulatory compliance will be vital for the successful development and launch of generic drug products. To qualify for this role, you should hold a Ph.D. in Pharmaceutical Sciences with at least 3 years of experience or an M.Pharm in Pharmaceutical Sciences with 6 years of experience from reputed universities. Experience in working with generic products in regulated markets such as the US, EU, or Canada is preferred. Your technical skills should include expertise in Formulation Development of Solid Oral Dosage forms, knowledge of recent ICH and regulatory guidelines, and understanding of Bioequivalence, GMP, Quality, and SOP compliance. Strong people skills, interpersonal skills, and the ability to work both independently and collaboratively with teams are essential for this role. If you are confident, detail-oriented, and passionate about making a difference in the pharmaceutical industry, we invite you to join our team and contribute to our mission of improving global health outcomes through affordable and accessible medicines.,

As a bench scientist in our organization, you will be responsible for conducting experimentation and research in the area of formulation development, process development, regulatory affairs, and intellectual property for global markets. Your work will involve planning and executing experiments aligned with project milestones while applying scientific principles such as Quality by Design (QbD), Design of Experiments (DoE), statistics, and scale-up principles. You will be expected to analyze and interpret data from literature reviews effectively to support decision-making processes. Additionally, you will need to understand the intellectual property landscape, develop strategies, search for prior art, and establish proof of concept through experimentation. Collaboration with cross-functional teams including Manufacturing Science and Technology (MS&T), Quality Assurance (QA), Quality Control (QC), and production teams across different geographies will be crucial for technology transfer and timely execution of submission batches. Your role will also involve identifying challenges, bottlenecks in development, and providing mitigation proposals at various stages of product development. Furthermore, you will be responsible for problem-solving, prioritizing activities, conducting development trials, and ensuring alignment with established milestones. Clear communication with internal stakeholders, proactive identification of challenges or risks, and adherence to business unit Key Performance Indicators (KPIs) will be essential aspects of your role. On a day-to-day basis, you will work closely with the formulation development teams to achieve key milestones, conduct experiments following QbD principles, and prepare presentations at different stages of product development. Your tasks will include literature reviews, sourcing API and Excipients, conducting preformulation studies, executing development trials, interpreting analytical data, and preparing necessary documentation for regulatory submissions. To be successful in this role, you should hold a Ph.D. in Pharmaceutical Sciences with at least 1 year of experience or an M.Pharm in Pharmaceutical Sciences with a minimum of 3 years of experience from reputable universities. Prior experience in working with generic pharmaceuticals in regulated markets such as the US, EU, or Canada will be advantageous. Your commitment to personal accountability, effective work habits, continuous learning, and collaboration with internal teams will be instrumental in contributing to the success of our organization's mission to make good health more affordable and accessible globally.,