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Senior Manager/Associate Director, Sterile Drug Product Development

Company: Engage Scientific
Location: Boston
Posted on: October 21, 2019

Job Description:

*LOCAL CANDIDATES ONLY*
*CONSIDERABLE KNOWLEDGE OF STERILE PRODUCT DEVELOPMENT IS REQUIRED*
You will play a vital role in drug product development and manufacturing within a young organization that is expanding as they continue to advance their clinical-stage assets. In addition, project management will be a critical component of this position and will help drive programs as a CMC lead. Currently, our client is located in Cambridge with plans to move to Post Office Square in Downtown Boston in November.
You will manage the development and implementation of parenteral Drug Product supply at Contract Manufacturing Organizations, collaborate with internal teams, consultants, development organizations, CMOs, and suppliers to support this key function for the organization. You will also be responsible for CMC Project Management.

About the Role

  • Provides input and executes drug product development and manufacturing strategy and timelines to ensure phase-appropriate formulation, processes, and methods.
  • Actively manage external development and manufacturing activities at Contract Manufacturing Organizations, ensuring close partnership through open and transparent communication, scientific and strategic understanding, and attention to priorities and details.
  • Establish effective relationships with all development and manufacturing partners to provide oversight and coordinate with internal teams.
  • Plan and organize development activities and manufacturing schedules with Contract Manufacturing Organizations (CMOs) ensuring consistent material availability for all non-clinical and clinical studies, including adequate planning for long lead time items
  • Review batch production records and written instructions to ensure cGMP compliance and maintain current quality standard
  • Review deviations, investigations, and CAPAs and make recommendations to Quality Assurance
  • Monitor CMO performance. Communicate findings, including risks and opportunities to internal stakeholders during project meetings and trigger corrective actions
  • Review essential elements of scale-up and technology transfer leading to successful process validation and a robust commercialization
  • Gather knowledge as the basis for the manufacturing control strategy, the approach for process qualification and continuous process improvements
  • Author and review sections for different regulatory documents and submissions
  • Working with all functions within Pharmaceutical Development and CMC and the Program Manager, utilize project management tools to lead CMC Project Management
  • Travel required -25% Education and Experience Requirements
    • BS, MS, Ph.D. degree in Sciences, Engineering, or Pharmaceutics
    • 5+ years of experience, based on degree, in the biopharmaceutical industry
    • Experience with parenteral formulation and manufacturing process development, pre-filled syringes a plus
    • Experience in formulation and manufacturing process development and validation of drug product processes
    • Experience in writing CMC regulatory documents for investigational drugs
    • Experience with peptides is preferred
    • Experience with project management tools
    • Team Player with excellent interpersonal skills Skills and Abilities
      • You are passionate about your work and display a high level of emotional intelligence in your decision making
      • You understand, appreciate, and thrive in a growing organization
      • You act with impeccable integrity and treat your colleagues, business partners, and customers with the utmost respect
      • You can understand the strategy, the transition to execution, and effectively lead teams and/or peers through this process
      • You strive for excellence and expect the same from your team and colleagues

Keywords: Engage Scientific, Worcester , Senior Manager/Associate Director, Sterile Drug Product Development, Executive , Boston, Massachusetts

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