CMC Submissions Lead

Job Title: CMC Submissions LeadTakeda Manufacturing USA, Inc. is seeking a highly skilled CMC Submissions Lead to join our team in Cambridge, MA.Job Summary:We are looking for a seasoned professional with expertise in global regulatory guidelines, Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and regulatory requirements for New...

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 RoleTakeda Pharmaceuticals is seeking a highly experienced Senior Director to lead our CMC Pharmaceutical Development Portfolio. As a key member of our Regulatory Affairs team, you will be responsible for establishing collaboration with Global CMC teams and leadership, enabling CMC regulatory team's success in meeting goals and objectives.Key...

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 DescriptionThe Chemistry Manufacturing Controls Associate Director plays a pivotal role in executing global regulatory CMC strategies for investigational and marketed products. This position leads the preparation and filing of regulatory CMC submissions and manages interactions with Health Authorities for CMC topics. Additionally, this role provides...

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 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...

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 Title: Drug Discovery LeadWe are seeking a highly skilled and experienced Drug Discovery Lead to join our Oncology Drug Discovery Unit at Takeda Pharmaceutical. As a key member of our team, you will be responsible for leading the discovery and development of innovative cancer therapies.Key Responsibilities:Lead and manage multiple drug discovery projects...

Job Title: Quality Assurance ManagerAt KMR Search Group, we are seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for designing, planning, implementing, and evaluating a quality assurance function and a quality management system that supports clinical development and regulatory...

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 SummaryWe are seeking a highly experienced and skilled professional to lead our Analytical Controls team as a Director. The successful candidate will be responsible for developing and implementing strategies to ensure the quality and compliance of our pharmaceutical products.Key ResponsibilitiesLead and develop a team of managers and scientists in the...

Job SummaryWe are seeking a highly experienced and skilled professional to lead our Analytical Controls team as Director, Analytical Controls US. As a key member of our Pharmaceutical Sciences organization, you will be responsible for developing and implementing strategies to ensure the quality and compliance of our analytical controls processes.Key...

Job Title: Registered Nurse - Per DiemJoin our team of dedicated healthcare professionals at Tufts Medicine, a leading integrated health system in Massachusetts. We are seeking a skilled Registered Nurse to work on a per diem basis in our Cardiomyopathy Center (CMC).About the Role:This is a challenging and rewarding role that requires a high level of...

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...

Job DescriptionAt Takeda Pharmaceutical, we are seeking a highly skilled Companion Diagnostic Lead to join our Oncology Therapeutic Area team. As a key member of our Precision Medicine function, you will play a critical role in developing and executing companion diagnostic strategies for early-stage oncology programs.Key ResponsibilitiesLead cross-functional...

Job Title: Companion Diagnostic LeadWe are seeking a highly skilled Companion Diagnostic Lead to join our team in the Oncology Therapeutic Area. As a key member of our Precision and Translational Medicine function, you will be responsible for leading the development and execution of companion diagnostic strategies for early-stage oncology programs.Key...