Senior Director of Sterile Drug Products
3 weeks ago
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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Boston, Massachusetts, United States BioSpace, Inc. Full timeJob SummaryWe are seeking a highly motivated and experienced Associate Director to lead sterile drug product development and manufacturing activities. This role focuses on ensuring the highest quality standards and regulatory compliance for late-stage development to commercialization of biologics.The ideal candidate will have a strong understanding of cGMP,...
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