CSG Talent | Senior Director CMC

2 days ago

boston, United States CSG Talent Full time

Senior Director - CMC (Antibody Drug Conjugate)

Our client is a biotechnology company focused on developing innovative therapies for a range of diseases, with an emphasis on precision medicine and immune-based treatments. The company works on harnessing the power of the immune system, using its proprietary platform to develop personalized therapies that target specific disease mechanisms. Our client utilizes advanced technologies such as artificial intelligence (AI), data analytics, and immune system profiling to identify and develop novel drug candidates that can address conditions in oncology and other areas with high unmet medical needs.

Their approach aims to create more effective and tailored treatments, improving patient outcomes while minimizing adverse effects. However, the specific areas of focus may evolve, so it's best to check for the latest updates directly from their website or recent publications.

  • Lead CMC (Chemistry, Manufacturing, and Controls) activities across the entire lifecycle, from pre-IND to IND/early-stage and late-stage development, covering process development, manufacturing, and supply chain management.
  • Develop and implement CMC strategies and development plans for multiple oncology-focused preclinical and clinical-stage Antibody-Drug Conjugate (ADC) programs.
  • Collaborate with CDMOs (Contract Development and Manufacturing Organizations) to establish scalable and reproducible manufacturing processes that align with target product profiles.
  • Provide CMC program management support, ensuring that timeline and budget goals are met.
  • Review key documents from CDMOs, including process development reports, master and executed batch records, stability protocols, change controls, and other necessary documentation.
  • Participate in internal ADC Project Team Meetings and CMC sub-team meetings. Represent the team in external meetings with CDMOs and other partners.
  • Author and review sections of regulatory filings, including pre-IND, IND/IMPD, annual reports, BLA/MAA, and others. Support interactions with regulatory authorities as required.
  • Ensure effective coordination across functions, including CMC, clinical, non-clinical, and regulatory teams, to support the execution of integrated program plans.
  • Proactively identify potential issues and obstacles that may affect the timely advancement of CMC deliverables, and collaborate with internal and external teams to resolve these challenges.

Qualifications:

  • A Bachelor's degree is required; a Master's or PhD is preferred.
  • Minimum of 12+ years of experience in CMC operations, CMC project management, or related scientific fields.
  • Strong experience with Antibody-Drug Conjugates (ADCs) is essential.
  • In-depth knowledge of CMC operations, quality, and regulatory requirements.
  • Proven ability to understand company priorities, objectives, and project timelines. Ability to define and manage critical paths, identify and escalate issues, and contribute to their resolution.
  • Strong troubleshooting skills, with the ability to address complex issues using appropriate information.
  • Ability to thrive in a fast-paced, cross-functional team environment. Capable of building consensus and resolving issues while maintaining positive working relationships across functions.
  • Demonstrated experience in coordinating among stakeholders with both technical and business priorities.

  • Senior Director CMC

    2 days ago

    Boston, United States CSG Talent Full time

    Senior Director - CMC (Antibody Drug Conjugate)Our client is a biotechnology company focused on developing innovative therapies for a range of diseases, with an emphasis on precision medicine and immune-based treatments. The company works on harnessing the power of the immune system, using its proprietary platform to develop personalized therapies that...

  • CSG Talent | Business Development Manager

    4 weeks ago

    boston, United States CSG Talent Full time

    CSG Talent is looking for a Business Development Manager for a pioneering force in microbial genomics, offering cutting-edge lab and bioinformatics services to the microbiome and infectious disease markets. The business needs to bring a Business Development Executive to drive growth within the US. If you're eager to advance your career with a dynamic and...

  • CSG Talent | Partner

    3 weeks ago

    boston, United States CSG Talent Full time

    Our client, a rapidly growing life science-focused boutique consulting firm, is seeking a Partner to deliver project work and help grow the business. Our client is seeking someone who can deliver recommendations, based on a wealth of relevant life sciences experience and thought leadership.The Partner should come with experience and drive to autonomously run...

  • CSG Talent | Architect/Project Manager | boston, ma

    2 weeks ago

    boston, United States CSG Talent Full time

    I'm working with a small architectural firm in Boston of 30 individuals who ideally need a registered architect (or a designer on the path to licensure) with around 8-10 years' industry experience, who is highly proficient using Revit and is capable of serving as a Project Architect on larger and more complex projects and as a Project Manager/Architect on...

  • Senior Cell Therapy CMC Program Director

    2 weeks ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About Takeda PharmaceuticalTakeda Pharmaceutical is a leading biopharmaceutical company dedicated to delivering innovative medicines to patients worldwide. With a strong commitment to research and development, we strive to address the most pressing healthcare challenges of our time.Job SummaryWe are seeking an experienced Senior Cell Therapy CMC Program...

  • Senior Director, CMC Regulatory Affairs Portfolio Lead

    3 weeks ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About TakedaTakeda Pharmaceutical is a global leader in transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs.As a patient-focused company, we strive to deliver Better Health and a Brighter Future to people around the world.Job OverviewWe are seeking an experienced Senior Director, CMC...

  • Business Development Manager

    4 weeks ago

    Boston, United States CSG Talent Full time

    CSG Talent is looking for a Business Development Manager for a pioneering force in microbial genomics, offering cutting-edge lab and bioinformatics services to the microbiome and infectious disease markets. The business needs to bring a Business Development Executive to drive growth within the US. If you're eager to advance your career with a dynamic and...

  • Senior Director, GRA CMC Pharmaceuticals Development Portfolio Lead

    1 month ago

    Boston, United States Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...

  • Director, GRA CMC Small Molecules

    4 weeks ago

    Boston, United States Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice...

  • Director, GRA CMC Small Molecules

    1 month ago

    Boston, United States Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...

  • Strategic Leader for Global CMC Regulatory Affairs

    3 weeks ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Transformative Leadership in Pharmaceutical DevelopmentAt Takeda, we are shaping the future of patient care through innovative pharmaceuticals and exceptional support programs. As a key member of our team, you will have the opportunity to make a lasting impact.About the Role:We seek an experienced Senior Director, GRA CMC Pharmaceuticals Development...

  • Regulatory Affairs Director, Global CMC Specialist

    3 weeks ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About the Role:Takeda Pharmaceutical is a patient-focused company committed to delivering Better Health and a Brighter Future to people around the world.We are seeking an experienced Regulatory Affairs Director, Global CMC Specialist to oversee the development and execution of regulatory CMC strategies for our pharmaceutical products.This role requires a...

  • Sr. Director, Global Regulatory CMC

    1 month ago

    Boston, United States Spur Therapeutics Full time

    Why Spur?Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of scientists,...

  • Sr. Director, Global Regulatory CMC

    1 month ago

    Boston, United States Spur Therapeutics Full time

    Why Spur?Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of scientists,...

  • Sr. Director, Global Regulatory CMC

    1 month ago

    boston, United States Spur Therapeutics Full time

    Why Spur?Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of scientists,...

  • Director, GRA CMC Small Molecules

    2 weeks ago

    Boston, MA, United States Takeda Pharmaceuticals Full time

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge....

  • Director, Global Regulatory Affairs, CMC Small Molecules

    2 weeks ago

    Boston, United States Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...

  • Associate Director/Director, Biologics CMC Regulatory Affairs

    2 weeks ago

    Boston, MA, United States Dechra Pharmaceuticals PLC Full time

    Vacancies Associate Director/Director, Biologics CMC Regulatory Affairs Job Introduction This is a US remote role, with a preference for candidates based in the Boston area. Invetx, a division of Dechra , is a veterinary biotechnology company focused on developing protein-based therapeutics for chronic conditions in companion animals, with an emphasis on...

  • Senior Director, GRA CMC Pharmaceuticals Development Portfolio Lead

    2 months ago

    Boston, MA, United States Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...

  • Regulatory Affairs CMC Director

    3 weeks ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    At Takeda Pharmaceutical, we are a world-class research and development organization that drives innovation and delivers life-changing therapies to patients worldwide.About the RoleWe are seeking a highly experienced Regulatory Affairs CMC Director to oversee the development and execution of regulatory strategies for our small molecules products. As a key...