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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

CMC Program Manager


Reference:SCANWB-172732 Location: Dublin
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: CMC Regulatory Affairs

CMC Program Manager
Our client, a biotech start-up are growing out their team and are currently recruiting for a CMC Program Manager to join their team on a permanent basis. As CMC Program Manager you will be responsible for the coordination and execution of all development, clinical manufacture and commercialization activities for injectable drug product. This includes activities covering supply of drug substance for use in clinical studies, vendor selection and oversight, process development, manufacture of clinical supply, registration and commercial manufacturing.


Responsibilities

  • Provide technical expertise and oversight in the development of the company’s injectable drug product, from formulation development through regulatory submission to commercialisation
  • Develop and execute the strategy for development and clinical study production of drug product in alignment with company goals and clinical plans
  • Oversee all CMC activities with vendors, relating to drug substance, drug product(s), and device(s), with particular focus on injectable drug product
  • Working with the Analytical Services Manager in the CMC team, oversee the design, development, validation, and transfer of suitable analytical methods and specifications related to injectable drug product for development and commercial manufacturing
  • Develop and control appropriate budgets and timelines
  • Contribute to activities related to DP and clinical service contractors and suppliers; e.g., selection, contracting, management, timelines and cost control
  • Interface with Quality to ensure vendors comply with GMP’s and Quality Agreements; manage process and/or documentation changes in a controlled manner; review vendor batch records, deviation reports, risk assessments, and CAPA’s; and ensure batches comply with specifications and processes
  • Manage and update the project and development plans assisting in the review of regulatory filings including IMPD and other specific CMC-related regulatory documents
  • Engage and follow up with CMOs on a regular basis to ensure projects progress as expected
  • Ensure face to face contact with CMOs as necessary during the critical phases. Act as a “person in the plant” during key stages of critical manufacturing campaigns (e.g. process validation)
Requirements
  • Master’s degree in a relevant scientific discipline required
  • Minimum 8 years of experience developing or manufacturing sterile / aseptic drug product through all phases of clinical development
  • Experience in the development of Injectable drug product formulations, scale-up, clinical supply and registration is preferred
  • Experience with intra-nasal and respiratory products and with combination products is beneficial but not essential
  • Solid experience with working in a regulated environment under GxP and with adherence to Company SOPs, policies and guidelines
  • Excellent communication, presentation, and interpersonal skills
  • Self-driven and motivated team player
  • Familiar with working in a virtual setup
  • Fluent in written and spoken professional English