Current jobs related to CMC Project Manager - Boston, Massachusetts - Dexian

  • Scientist, CMC

    4 weeks ago


    Boston, Massachusetts, United States PepGen Full time

    Job OverviewPepGen is seeking a highly skilled Scientist, CMC to contribute to the development of our Enhanced Delivery Oligonucleotides (EDOs) pipeline. As a key member of our CMC team, you will work closely with external partners to develop optimized chromatography processes for purifying target entities.ResponsibilitiesDevelop and implement process...


  • Boston, Massachusetts, United States Vertex Pharmaceuticals Full time

    Job Summary:The Director, Regulatory CMC, Biologics will lead a team in the execution of global regulatory CMC strategies for investigational and marketed biologics products. This role is accountable for the preparation and filing of regulatory CMC submissions and managing interactions with Health Authorities for CMC topics.Key Responsibilities:Oversee the...

  • CMC Submissions Lead

    4 weeks ago


    Boston, Massachusetts, United States Takeda Full time

    Job Title: CMC Submissions LeadTakeda Manufacturing USA, Inc. is seeking a highly skilled CMC Submissions Lead to join our team in Cambridge, MA. As a key member of our regulatory affairs team, you will be responsible for creating and maintaining regulatory submission content plans, timelines, and submission strategies for CMC Module 3 information.Key...


  • Boston, Massachusetts, United States Takeda Pharmaceuticals Full time

    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...

  • CMC Submissions Lead

    2 weeks ago


    Boston, Massachusetts, United States Takeda Full time

    Job Title: CMC Submissions LeadTakeda Manufacturing USA, Inc. is seeking a highly skilled CMC Submissions Lead to join our team in Cambridge, MA.Key Responsibilities:Develop and maintain regulatory submission content plans, timelines, and submission strategies.Establish submission structures in electronic common technical document format for CMC Module 3...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About the Role:Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.We are seeking a highly experienced Director, Regulatory Affairs CMC Small Molecules to oversee the development and execution of regulatory CMC development and registration...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About the Role:Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs.We are seeking a highly experienced Senior Director to lead our GRA CMC Pharmaceuticals Development Portfolio team.Key Responsibilities:Establish collaboration with Global...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About the Role:Takeda is a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. We are seeking a highly skilled Manager, Global Regulatory Affairs CMC Submission Management to support the execution of regulatory CMC investigational, registration and post-approval tasks for assigned...


  • Boston, Massachusetts, United States Takeda Pharmaceuticals Full time

    Job Description:Takeda Pharmaceuticals is seeking a highly skilled Senior Director, Cell Therapy CMC Program Lead to join our team in Cambridge, MA. The ideal candidate will have a Master's degree in Biotechnology, Biomedical Engineering, or a related field, along with 5 years of experience in cell and gene therapy development.Key Responsibilities:Develop,...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Job DescriptionTakeda Pharmaceutical is seeking a highly skilled Technical Regulatory Advisor GRA CMC, Drug-Device Combinations US to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing innovative device and integral/co-packaged combination product regulatory strategies for development, registration,...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About the Role:Takeda Pharmaceutical is seeking a highly skilled Regulatory Affairs Manager to support the execution of regulatory CMC investigational, registration, and post-approval tasks for assigned products. As a key member of the Regulatory Affairs CMC team, you will work closely with cross-functional teams to develop project plans for global...


  • Boston, Massachusetts, United States Vertex Pharmaceuticals Full time

    Job DescriptionVertex Pharmaceuticals is seeking a highly skilled Associate Director, CMC Compliance to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the compliance of our vendors with regulatory requirements.Key Responsibilities:Develop and maintain a comprehensive vendor quality management...


  • Boston, Massachusetts, United States Vertex Pharmaceuticals Full time

    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...


  • Boston, Massachusetts, United States Vertex Full time

    Job SummaryThe Chemistry Manufacturing Controls Associate Director at Vertex is responsible for executing global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and manages interactions with Health Authorities for CMC topics. The Associate Director provides...


  • Boston, Massachusetts, United States Project Farma Full time

    Why Precision for Medicine?Welcome to the forefront of innovation in cutting-edge patient treatments. As a leader within the life science industry, we are constantly pushing the boundaries of what is possible and redefining the standards of excellence.Our dynamic team is composed of vibrant professionals who are passionate about delivering high-quality work...


  • Boston, Massachusetts, United States Vertex Full time

    Job Title: Associate Director, Chemistry Manufacturing ControlsJob Summary:The Associate Director, Chemistry Manufacturing Controls, plays a critical 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...

  • Senior Scientist

    7 days ago


    Boston, Massachusetts, United States Takeda Full time

    About the RoleAt Takeda, we are a forward-thinking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. As a Senior Scientist - Analytical Development, you will provide and drive theoretical/conceptual input to the design, development, and execution of research assignments for a specific project or projects...

  • Project Engineer

    4 weeks ago


    Boston, Massachusetts, United States Project Farma Full time

    Job SummaryProject Farma is seeking a highly skilled Project Engineer to join our team. As a Project Engineer, you will work collaboratively with partners, vendors, contractors, and other Project Farma team members to support projects related to biomanufacturing across the entire lifecycle. Your primary responsibility will be to deliver high-quality work,...


  • Boston, Massachusetts, United States KMR Search Group Full time

    The Director of Quality Management at KMR Search Group is responsible for overseeing the development, implementation, and evaluation of a quality management system that supports clinical development and regulatory approval of products.This role requires extensive interaction with Clinical Operations, Pharmaceutical Operations, Program and CMC project...


  • Boston, Massachusetts, United States Project Farma Full time

    About Project FarmaWe are a leading advanced therapy technical operations consulting company in the life science industry. Our mission is to advance manufacturing to achieve operational excellence and accelerate speed to market for next-generation medicines.Job Title: Director, Project Controls EngineeringWe are seeking a highly skilled Director, Project...

CMC Project Manager

2 months ago


Boston, Massachusetts, United States Dexian Full time

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 activities.
  • Assigning tasks to team members based on their strengths and expertise, fostering effective communication and collaboration between device and cell teams.
  • Acting as a liaison for teams when multiple units are engaged in the same project, ensuring cohesive team efforts.
  • Conducting quality assurance throughout the project lifecycle to uphold standards consistent with Good Manufacturing Practices (GMP).
  • Modifying project schedules and objectives as necessary, while closely collaborating with project managers overseeing scale-up processes.
  • Working with workstream leaders to communicate recommendations, decisions, actions, and other critical information.
  • Summarizing essential updates such as program progress, timeline adjustments, and risk assessments for regular presentations to upper management.

Qualifications:

  • Comprehensive understanding of the drug development lifecycle, including manufacturing, scale-up, and regulatory frameworks.
  • Exceptional project management capabilities, with proficiency in planning, organizing, prioritizing tasks, managing budgets, and tracking project milestones.
  • Strong interpersonal and communication skills, with the ability to lead and collaborate effectively with cross-functional teams and external partners.
  • Experience with project management software and tools, such as Microsoft Project, Jira, or similar platforms, to manage intricate projects and timelines.
  • Familiarity with automation tools like PowerBI and SharePoint to enhance operational efficiency.
  • Outstanding verbal and written communication skills, with the ability to convey complex concepts and objectives clearly to diverse team members.
  • Project Management Professional (PMP) certification is preferred.

Dexian stands as a leading provider of staffing, IT, and workforce solutions, employing over 12,000 individuals across 70 locations globally. As one of the largest IT staffing firms and the second-largest minority-owned staffing company in the United States, Dexian was established in 2023 through the merger of DISYS and Signature Consultants. By integrating the strengths of its foundational companies, Dexian's platform connects talent, technology, and organizations to drive transformative results that empower everyone to achieve their aspirations and objectives.

Dexian's portfolio includes brands such as Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development, and Dexian IT Solutions. Visit our website to learn more.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.