Senior Director of Sterile Drug Products

3 weeks ago


Boston, Massachusetts, United States BioSpace, Inc. Full time

Job Summary:

This role focuses on ensuring the highest quality standards and regulatory compliance for late-stage development to commercialization of biologics. As a key member of the BioSpace, Inc. team, you will play a crucial role in vendor management and act as the subject matter expert for sterile drug products.

Key Responsibilities:

  • Oversee the production of sterile drug products, ensuring their quality, efficacy, and stability.
  • Collaborate with cross-functional teams and CDMOs to identify risks and opportunities for process optimization, manage quality and regulatory risks, and develop solutions.
  • Act as primary point of contact for CDMOs and manage vendors for sterile drug product manufacturing day-to-day activities.
  • Ensure effective communication and collaboration with vendors to achieve project goals and timelines.
  • Travel to CDMOs for new project kick-off meetings and regular business review meetings.
  • Develop and maintain comprehensive databases for sterile drug product development and manufacturing data.
  • Ensure data integrity and compliance with regulatory requirements.
  • Collaborate with the Quality Assurance department to guarantee product quality and regulatory compliance.
  • Prepare for and participate in regulatory inspections and audits, providing required documentation and support.

Requirements:

  • PhD in Pharmaceutical Sciences, Biotechnology, or related fields preferred.
  • Minimum 8 years of experience in GMP-regulated sterile drug product manufacturing and validation, with a focus on biologics, lyophilization, and fill/finish operations in CMC late-stage development within the biotech/pharmaceutical industry.
  • Experience in MBRs, EBRs, SOPs, GMP documents review and authoring relevant technical documents and CMC sections for IND/BLA submission.
  • Proven experience in vendor management for sterile drug products.
  • Experience with database management systems for scientific data.
  • In-depth knowledge of regulatory requirements and quality systems in the biotech/pharmaceutical industry.
  • Excellent problem-solving abilities and the capacity to drive process improvements.
  • Experience with regulatory inspections and audits is a plus.

Travel Requirements:

Ability to travel 10-20% of time to support external vendor activities.



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