CMC Director

4 weeks ago


Dublin, Dublin City, Ireland Scientificjobs Full time

CMC Director
Our client, clinical-stage biopharmaceutical company are currently recruiting for a CMC Director to join their team on a permanent basis. As CMC Director, you will coordinate, manage and provide technical oversight of the CMC team responsible for the development of drug substance, drug product and analytical methods.

Responsibilities:

Coordinate a technical team in the execution of a complex combination product development program working collaboratively within the cross functional team structure Accountable for development of the drug substance synthesis process, drug product manufacturing, and the development of associated analytical methods Develop and maintain the CMC Pharmaceutical development plan and budget, including all DS, DP and Analytical Development work packages Implement the CMC strategy including vendor selection and management, clinical and commercial supply chain strategy, second source supply strategy and risk management Manage CMC program risks and issues, evaluate contingency plans and risk mitigation activities, while ensuring effective communication with senior managementAuthor and review of Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, meeting requests, and briefing documents) Requirements:
Minimum of Masters degree in relevant scientific discipline required, with 12+ years industry experience including R&D and / or Technical Development Strong understanding of ISCH guidance's across all relevant disciplines. An understanding of ISO 13485 and FDA regulations on drug-device combination product development is advantageous Prior experience in working on combination product development programs essential Experience in development of products for pulmonary delivery preferred Proven ability to successfully achieve results within a multi-cultural and geographically diverse cross-functional team An entrepreneurial, business-oriented mindset and willing to "roll their sleeves up" attitude A self-starter and comfortable working on their own initiative Ability to perform multiple tasks simultaneously under direction and prioritise workload Maintain a professional and positive attitude and present clear instruction/direction to team members Prov
  • CMC Director

    2 weeks ago


    Dublin, Dublin City, Ireland TN Ireland Full time

    CMC DirectorOur client, a clinical-stage biopharmaceutical company, is currently recruiting for a CMC Director to join their organization on a permanent basis. As CMC Director, you will coordinate, manage, and provide technical oversight of the CMC team responsible for the development of drug substance, drug product, and analytical methods.About this...

  • CMC Director

    3 weeks ago


    Dublin, Dublin City, Ireland TN Ireland Full time

    CMC DirectorOur client, a clinical-stage biopharmaceutical company, is currently recruiting for a CMC Director to join their team on a permanent basis. As CMC Director, you will coordinate, manage, and provide technical oversight of the CMC team responsible for the development of drug substance, drug product, and analytical...

  • CMC Director

    2 weeks ago


    Dublin, Dublin City, Ireland Scientificjobs Full time

    CMC DirectorWe are a clinical-stage biopharmaceutical company seeking a highly skilled CMC Director to lead our development team. As CMC Director, you will oversee the technical aspects of developing drug substance, drug product, and analytical methods.Responsibilities:Coordinate a technical team in the execution of a complex combination product development...

  • CMC Director

    1 week ago


    Dublin, Dublin City, Ireland The RFT Group Full time

    2 days ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.Direct message the job poster from The RFT Groupunique authority in executive search for global based innovation driven drug development companiesCMC DirectorLed by a highly respected entrepreneurial leadership team, blessed with a proven track record in...

  • CMC Director

    3 weeks ago


    Dublin, Dublin City, Ireland The RFT Group Full time

    CMC DirectorLed by a highly respected entrepreneurial leadership team, blessed with a proven track record in building successful young start-ups, our client is a young, exciting, rapid growing clinical stage biopharmaceutical business poised to deliver an important break though in a debilitating condition characterised by chronic unmet need.This role offers...

  • CMC Development Lead

    2 weeks ago


    Dublin, Dublin City, Ireland beBee Careers Full time

    Product Development DirectorWe require a seasoned Product Development Director to lead our CMC development program. In this role, you will be accountable for developing the drug substance synthesis process, drug product manufacturing, and associated analytical methods.


  • Dublin, Dublin City, Ireland beBee Careers Full time

    The Director, CMC will play a key role in the development program for a novel inhalation combination product for treatment of neurological conditions, as well as intravenous drug development programs. The successful candidate will be accountable for the development of drug substance, drug product, and associated analytical methods via a risk-based approach.


  • Dublin, Dublin City, Ireland Infoempregos Full time

    Job Description:We are seeking a highly motivated individual to lead project-driven regulatory interactions with health authorities such as the FDA and EMA, providing scientific advice on CMC.This role presents an excellent opportunity for growth and development in a dynamic environment.Key Responsibilities:Establish and maintain relationships with key...


  • Dublin, Dublin City, Ireland Infoempregos Full time

    Job Description:Lead project-driven regulatory interactions with health authorities, e.g., FDA, EMA, for CMC scientific advice.We are looking for a young talent to join our team in a position with no previous experience required.If you are proactive and eager to learn, contact usRequirements:Willingness to learn and adapt to new challenges.Good verbal and...

  • CMC Regulatory Lead

    2 weeks ago


    Dublin, Dublin City, Ireland beBee Careers Full time

    Regulatory Affairs Director Role">We are seeking a highly motivated individual to lead project-driven regulatory interactions with health authorities.This role presents an excellent opportunity for growth and development in a dynamic environment.Key Responsibilities:Establish and maintain relationships with key stakeholders in the healthcare industry.Provide...