CMC Submissions Lead

Job DescriptionTakeda Manufacturing USA, Inc. is seeking a highly skilled CMC Submissions Lead to join our team in a full-time capacity. As a key member of our regulatory affairs team, you will be responsible for ensuring the timely and accurate submission of CMC Module 3 information to regulatory authorities.Key Responsibilities:Develop and maintain a...

Job Title: CMC Expert - BiologicsLocation: Hybrid (NJ, Boston)Job Description:We are seeking a highly skilled CMC Expert specializing in Biologics to provide regulatory and lifecycle management support for a large client. This role is instrumental in fulfilling client needs for regulatory submissions, ensuring compliance with post-approval processes, and...

About the RoleAt Takeda Pharmaceutical, we are a forward-thinking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients...

Job OverviewVertex is seeking a highly skilled Associate Director of Chemistry Manufacturing Controls to execute global regulatory CMC strategies for investigational and marketed products. This role will lead the preparation and filing of regulatory CMC submissions, manage interactions with Health Authorities, and provide regulatory guidance to...

Job OverviewVertex is seeking a highly skilled Associate Director to lead our Regulatory Submission Management team. As a key member of our Global Regulatory Affairs (GRA) function, you will be responsible for driving comprehensive plans and reports that ensure timely and successful regulatory submissions across multiple programs.Key Responsibilities:Develop...

Job Overview: Dexian is in search of a CMC Project Manager to support a prominent client in the pharmaceutical sector.Key Responsibilities:Developing and implementing both long-term and short-term strategies for projects focused on combination products, ensuring milestone targets are met and deadlines are adhered to while managing all project scheduling...

OverviewThe Vice President of Chemistry, Manufacturing, and Controls (CMC) plays a pivotal role in leading and managing the manufacturing operations at Replimune. This position is essential for overseeing the global Process Development function, ensuring that all aspects of drug substance and product development are executed effectively. The role encompasses...

Position Overview: Dexian is looking for a CMC Project Manager to support our client in Boston, MA.Key Responsibilities:Developing and implementing both long-term and short-term strategies for projects focused on combination products, ensuring that milestones are met and deadlines are adhered to while managing all project scheduling activities.Assigning...

Job SummaryWe are seeking a highly experienced and skilled professional to lead our Analytical Controls team. As a key member of our Pharmaceutical Sciences organization, you will be responsible for overseeing the development and implementation of analytical controls strategies to ensure the quality and safety of our products.Key ResponsibilitiesLead and...

About the RoleWe are seeking a highly experienced and skilled professional to join our team as a Director, Analytical Controls US. This is a key leadership position that will play a critical role in driving the success of our Analytical Controls team.Key ResponsibilitiesLead and develop a team of managers and scientists in the field of analytical controls...

Job Title: Director of Cell and Molecular BiologyVerve Therapeutics, Inc. is seeking a highly skilled Director of Cell and Molecular Biology to join its Analytical Development-CMC team. The successful candidate will be responsible for leading the development and qualification of analytical methods for mRNA and gRNA oligonucleotide drug substance and drug...

Job OverviewCompany OverviewVerve Therapeutics, Inc. is a pioneering clinical-stage company focused on genetic medicine aimed at addressing the global health crisis of cardiovascular disease. Established by leading experts in cardiovascular health, human genetics, and gene-editing, Verve is at the forefront of transforming the treatment landscape from...

Job SummaryThe Replimune Group is seeking an experienced and skilled Vice President of Manufacturing and Process Development to lead our Manufacturing function at our Framingham site and the supporting global Process Development function.Key ResponsibilitiesManufacturing: Provide strategic leadership and direction to the Operations functions, establishing...

Job OverviewLuminary Group is on the lookout for a skilled and knowledgeable Biostatistics Team Lead to join our esteemed client. In this pivotal role, you will be instrumental in directing and overseeing the biostatistics and data management operations within the organization. Your primary responsibility will be to ensure the meticulous design, analysis,...

About the RoleWe are seeking a highly skilled Companion Diagnostic Lead to join our team in Cambridge. As a key member of our Precision and Translational Medicine function, you will play a critical role in developing and executing companion diagnostic strategies for our Oncology programs.Key ResponsibilitiesLead cross-functional teams to develop and...

About the RoleWe are seeking a highly skilled Companion Diagnostic Lead to join our team in Cambridge. As a key member of our Precision and Translational Medicine function, you will play a critical role in developing and executing companion diagnostic strategies for our Oncology programs.Key ResponsibilitiesLead cross-functional teams to develop and...

About the RoleWe are seeking a highly skilled Companion Diagnostic Lead to join our team at Takeda Pharmaceuticals. As a key member of our Precision Medicine team, you will play a critical role in developing and executing companion diagnostic strategies to support our oncology programs.Key ResponsibilitiesLead cross-functional teams to develop and implement...

Job SummaryWe are seeking a highly skilled Proposal Manager to join our team at the Center for EcoTechnology. As a key member of our business development team, you will be responsible for driving our business growth strategy and ensuring the successful execution of our proposals.Key ResponsibilitiesDevelop and implement strategic growth initiatives to drive...

Position OverviewThe Creative Lead is responsible for conceptualizing and producing exceptional, award-winning designs. This role requires a visionary approach, bringing forth original ideas and presenting them effectively in client meetings. Our Creative Leads are driven to innovate and continuously refine their unique artistic style.Key...

Position OverviewABOUT ELEKTROFI INCElektrofi Inc is at the forefront of transforming the administration of biologic therapies, empowering patients with the flexibility to choose how they receive essential medications. Our innovative ultra-high concentration microparticle technology addresses the challenges linked to traditional intravenous biologic...