Life Science Jobs at Dana-Farber Cancer Institute
The Dana-Farber Cancer Institute is hiring a Cell Manufacturing Quality Specialist II to support quality assurance, compliance, and continuous improvement activities within its Cell Manufacturing and Cell Therapy Facility (CMCF). This role plays a critical part in ensuring patient safety, regulatory compliance, and product integrity in a fast-evolving cell therapy and cGMP environment. Based in Boston, Massachusetts, the Life Science Jobs at Dana-Farber Cancer Institute offer the opportunity to contribute directly to life-changing cancer research and advanced patient care.
Job Details:
- Job Title: Cell Manufacturing Quality Specialist II
- Job Reference: JR-84
- Category: Quality / Risk Management / Patient Safety
- Employment Type: Full-time
- Work Location: Boston, MA (450 Brookline Ave)
- Salary Range: $86,400 – $93,200 per year
- Patient Contact: None
- Supervisory Responsibilities: None
About the Company:
Dana-Farber Cancer Institute is a world-renowned leader in cancer research, treatment, and education, affiliated with Harvard Medical School. The Institute is dedicated to conquering cancer, HIV/AIDS, and related diseases through groundbreaking research, compassionate patient care, and innovative cell and gene therapies. Dana-Farber fosters an inclusive, diverse, and equitable workplace, ensuring every employee feels valued while making a meaningful impact on global healthcare.
Educational Requirements for the Quality Specialist Role:
- Bachelor’s degree (BS/BA) in Life Science, or a related field
- Minimum 2 years of quality assurance and cGMP experience
- Minimum 1 year of laboratory experience in a relevant setting
Key Responsibilities of the Quality Specialist:
- Perform novel and complex batch record reviews, ensuring accuracy, completeness, and compliance.
- Apply in-depth process knowledge to assess product readiness and prevent release when requirements are not met.
- Conduct complex data analysis and quality reporting
- Perform and manage internal and select external audits, including audit findings and recommendations
- Participate in process improvement initiatives and quality system enhancements
- Review deviations and support RCA (Root Cause Analysis) and CAPA activities
- Support validation plan reviews and completed validation documentation
- Participate in document control systems, supporting multidisciplinary teams
- Suggest and implement new audit areas to improve compliance and quality outcomes
- Maintain regulatory compliance with FACT, Joint Commission (JC), FDA, DPH, CMS, and DOT standards
Skills Required for the Quality Specialist Role:
- Strong knowledge of cGMP and quality management systems
- Experience with batch record review and deviation management
- Proficiency in RCA, CAPA, audits, and validation documentation
- Excellent critical thinking and problem-solving abilities
- Ability to perform complex calculations related to cell therapy dosing
- Strong organizational and time management skills
- Advanced proficiency in Microsoft Office applications
- Ability to work independently with minimal supervision
- Strong communication skills for cross-functional collaboration
- Ability to identify risks that may impact patient safety and product quality
Benefits of the Life Science Jobs at Dana-Farber Cancer Institute:
- Competitive annual salary within a structured pay transparency framework
- Comprehensive medical, dental, and vision insurance
- Retirement savings plans
- Paid time off and holidays
- Access to continuing education and professional development
- Opportunity to work at the forefront of cell and gene therapy innovation
- Inclusive, mission-driven workplace culture
- Contribution to life-saving research and patient outcomes
