- Takeda Pharmaceuticals (Boston, MA)
- …therapies to patients worldwide. Join Takeda as a Senior Director, GRA CMC Pharmaceuticals Development Portfolio Lead where you will establish collaboration ... with members of the team, develop high quality clinical, commercialization and LCM submissions , using proactive regulatory CMC strategies and submit them as… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Director GRA CMC where you will independently develop and lead the execution of ... registration and/or pos-approval strategies for assigned products as GRA CMC Product Lead . Represents and contributes to...you will contribute:** + Develops, executes and oversees regulatory submissions preparation per the GRA CMC Product… more
- Takeda Pharmaceuticals (Boston, MA)
- …having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience preferred. + ... which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance within the organization. + Lead team members… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** Takeda Development Center Americas, Inc. is seeking an Associate Director, CMC Program Lead , Cell Therapies in Cambridge, MA with the ... and product quality improvement in Chemistry, Manufacturing & Control ( CMC ) processes; Employ technical project management principles (project planning, RACI,… more
- Actalent (Boston, MA)
- …to agency questions, and maintenance activities. + Coordinate and drive regulatory CMC submissions , including assembling necessary cross functional teams and ... to accommodate flexible hybrid schedule Responsibilities: + Actively represent Regulatory CMC and provide regulatory expertise as a member of interdisciplinary teams… more
- Takeda Pharmaceuticals (Boston, MA)
- …right first time. + Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and establishes mechanisms to communicate them ... for demonstrating Takeda leadership behaviors + Serves as Drug-Device Combinations US lead for assigned asset programs + In consultation with Platform Regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …any other characteristic protected by law **_Objective / Purpose:_** The Drug Discovery Lead (DDL) serves as a strategic leader within the Oncology Drug Discovery ... that deliver game-changing, highly differentiated, therapeutic opportunities for patients. + Lead and manage multiple drug discovery projects, overseeing the entire… more
- Sanofi Group (Cambridge, MA)
- …possible. Ready to get started? Sanofi is seeking an **Analytical Development Director** to lead the analytical group in our CMC function at Cambridge Crossing ... which is part of the synthetic platform within Global CMC Development. We are striving to become an industry...oral dosage forms at Sanofi's Cambridge Crossing site + Lead the analytical team to provide support for studies… more
- Sanofi Group (Waltham, MA)
- …+ **Align GAD research activities** with clinical trial expectations, including IND submissions , support for CMC (Chemistry, Manufacturing, and Controls), and ... to all, regardless of gender._ **Job title:** Global Antigen Design (GAD) Research Lead bacteriology + _Location: Marcy l'Etoile (69)_ **_About the job_** Are you… more
- Merck (Boston, MA)
- …CMC Oversight + Lead the preparation and submission of high-quality regulatory CMC device content for global submissions , including IND, NDA, BLA, and MAA ... The individual will also manage the regulatory Chemistry, Manufacturing, and Controls ( CMC ) content for global submissions , ensuring adherence to international… more
- Organon & Co. (Boston, MA)
- …in the US** The Director, Translational Medicine and Early Development (TMED) Lead will be responsible for contributing and/or devising the early clinical ... development strategy supporting development assets within the Organon portfolio. The TMED Lead also will be responsible for the rationale, study design and oversight… more
- Sanofi Group (Waltham, MA)
- …cycle management. Responsible for regulatory statistical responses and medical journal submissions . + Accountable for deploying CMC vaccines statistical support ... Sanofi Vaccines as the **Director of Non-clinical Biostatistics** where you will lead a team of experts and deploy state-of-the-art statistical designs and analysis… more
- AbbVie (Cambridge, MA)
- …The Molecular Profiling and Drug Delivery (MPDD) function within the Small Molecule CMC organization is accountable for a broad range of deliverables across various ... stages of drug discovery and development. During lead optimization and through candidate selection, MPDD scientists utilize state of the art automation and… more
- Editas Medicine (Cambridge, MA)
- …(LNP) and Ribonucleoprotein (RNP) product development. The successful candidate will lead a high-performing team, coordinating with process and analytical experts ... also be a key contributor to the overall program CMC strategy. This role requires strong technical expertise in...design and development as well as a passion to lead , mentor and influence people. Characterizing Your Impact: As… more
- Takeda Pharmaceuticals (Lexington, MA)
- …new product programs. + Author and review of regulatory information packages and filings/ submissions . + Execute or lead packaging design activities by designing ... Join Takeda as a Packaging Development Engineer IV where you will lead innovation, development, testing, and validation of all packaging materials for… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Quality by Design (AQbD) + Experience in reviewing and approving analytical-related CMC sections of BLA/MAA regulatory submissions . Knowledgeable in European, ... Analytical Development, it is expected that the individual will independently lead efforts in development of appropriate scientific methods and technology,… more
- Novo Nordisk (Lexington, MA)
- …Director helps develop products within the Novel Modalities team as the medical lead of the ATTR cardiomyopathy project. In doing so, the Senior International ... data analyses. The Senior International Medical Director will also take medical lead in the development and execution of strategic priorities within the therapeutic… more
- Editas Medicine (Cambridge, MA)
- …nanoparticle technology. The individual will also contribute to the overall program CMC strategy. This role requires strong technical expertise in mRNA manufacturing ... scale-up, and continuous improvement to meet clinical manufacturing demand + Lead /support technology transfer (TT) of mRNA manufacturing process to external… more
- Sanofi Group (Cambridge, MA)
- …the development and update of the core global dossier / collaborates with regional lead where region-specific submissions are applicable. + Leads the IND/ CTA ... Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their regulatory expertise to… more
- Sanofi Group (Cambridge, MA)
- …relevant to drug delivery and influence team strategies. + **Collaborate within the CMC team** as the Formulation Lead and actively contribute to defined ... formulations. + **Collaborate with Regulatory and program leads** to support submissions and approval of product applications. + **Review and provide feedback… more