Business Services & Consulting • Needham Heights, MA 02494
This is a hybrid role in Needham, MA office (2-3 days a week) Salary: $258,000-$285,000 Why Work With Us?At Candel, our people drive our success.We value diversity, collaboration, and bold thinking in a supportive, mission driven environment.Like a team, we show up for each other and stay focused on making a difference for patients and families.Our leadership is transparent and empowering, and our culture is built on trust, flexibility, and accountability, encouraging ownership and innovation every day.
If you thrive in a lean, fast moving environment where your work truly matters, you will feel at home here.Our Science: Advancing Cancer Immunotherapies Candel is a clinical stage biopharmaceutical company developing off the shelf, multimodal cancer immunotherapies designed to stimulate personalized, systemic anti tumor immune responses.Our proprietary platforms leverage genetically modified adenovirus and HSV constructs.With positive Phase 3 results for our lead candidate, this is a pivotal and exciting time to join Candel and help bring transformative cancer treatments to patients.
Position Summary: The Senior Director, QC Laboratory is responsible for the establishment, leadership, and ongoing operation of Candel Therapeutics' internal GMP Quality Control laboratory.The Senior Director, QC Laboratory will provide leadership, direction, and technical oversight to the QC team while ensuring compliance with GMP requirements and internal quality standards.This role partners closely with Quality Assurance, Analytical Development, R&D, Manufacturing, and other internal stakeholders to support clinical development activities and future organizational growth.
Essential Areas of Responsibility: • Provide leadership and oversight for the internal GMP QC laboratory, including establishment of laboratory operations, workflows, and execution standards. • Lead, mentor, and develop QC laboratory staff, fostering a collaborative, accountable, and compliant team culture. • Directly manage internal QC staff and future laboratory growth, supporting performance, development, and organizational readiness. • Ensure QC laboratory operations are conducted in compliance with GMP requirements, internal SOPs, and data integrity expectations. • Serve as a key QC partner to Quality Assurance for deviations, investigations, change controls, CAPAs, and inspection readiness activities. • Provide hands-on leadership and operational support in the laboratory environment as needed to meet business and quality objectives. • Collaborate cross-functionally with Analytical Development, R&D, Manufacturing, Regulatory Affairs, and other internal stakeholders to support testing needs and program timelines. • Support audit and inspection activities related to QC laboratory operations, documentation, and systems. • Implement and maintain practical, scalable QC processes appropriate for a growing biotech organization. • Drive continuous improvement initiatives within the QC laboratory while maintaining appropriate controls and compliance. • Contribute to staffing plans, onboarding, training, succession planning, and long-term QC capability development.
Minimum Education, Experience and Skill Requirements: Education: • Bachelor's degree in a scientific discipline required; advanced degree preferred.
Experience: • Minimum of 10 years of experience in a GMP Quality Control laboratory environment within biotech or pharmaceutical organizations. • Demonstrated experience operating within a true QC organization, with a strong understanding of QC structure, controls, and GMP rigor. • Prior experience leading, mentoring, or managing QC laboratory staff. • Experience supporting GMP inspections, audits, and quality system activities impacting QC operations. • Strong interpersonal, leadership, and communication skills with the ability to partner effectively across functions. • Comfort working in a build-phase or evolving environment where systems and infrastructure are developing. • Proficiency with standard office software including Microsoft Word, Excel, and PowerPoint.
Must be authorized to work in US.We cannot provide sponsorships. *** NOTE: We are not accepting resumes from agencies. ***
This is a hybrid role in Needham, MA office (2-3 days a week) Salary: $258,000-$285,000 Why Work With Us?At Candel, our people drive our success.We value diversity, collaboration, and bold thinking in a supportive, mission driven environment.Like a team, we show up for each other and stay focused on making a difference for patients and families.Our leadership is transparent and empowering, and our culture is built on trust, flexibility, and accountability, encouraging ownership and innovation every day.
If you thrive in a lean, fast moving environment where your work truly matters, you will feel at home here.Our Science: Advancing Cancer Immunotherapies Candel is a clinical stage biopharmaceutical company developing off the shelf, multimodal cancer immunotherapies designed to stimulate personalized, systemic anti tumor immune responses.Our proprietary platforms leverage genetically modified adenovirus and HSV constructs.With positive Phase 3 results for our lead candidate, this is a pivotal and exciting time to join Candel and help bring transformative cancer treatments to patients.
Position Summary: The Senior Director, QC Laboratory is responsible for the establishment, leadership, and ongoing operation of Candel Therapeutics' internal GMP Quality Control laboratory.The Senior Director, QC Laboratory will provide leadership, direction, and technical oversight to the QC team while ensuring compliance with GMP requirements and internal quality standards.This role partners closely with Quality Assurance, Analytical Development, R&D, Manufacturing, and other internal stakeholders to support clinical development activities and future organizational growth.
Essential Areas of Responsibility: • Provide leadership and oversight for the internal GMP QC laboratory, including establishment of laboratory operations, workflows, and execution standards. • Lead, mentor, and develop QC laboratory staff, fostering a collaborative, accountable, and compliant team culture. • Directly manage internal QC staff and future laboratory growth, supporting performance, development, and organizational readiness. • Ensure QC laboratory operations are conducted in compliance with GMP requirements, internal SOPs, and data integrity expectations. • Serve as a key QC partner to Quality Assurance for deviations, investigations, change controls, CAPAs, and inspection readiness activities. • Provide hands-on leadership and operational support in the laboratory environment as needed to meet business and quality objectives. • Collaborate cross-functionally with Analytical Development, R&D, Manufacturing, Regulatory Affairs, and other internal stakeholders to support testing needs and program timelines. • Support audit and inspection activities related to QC laboratory operations, documentation, and systems. • Implement and maintain practical, scalable QC processes appropriate for a growing biotech organization. • Drive continuous improvement initiatives within the QC laboratory while maintaining appropriate controls and compliance. • Contribute to staffing plans, onboarding, training, succession planning, and long-term QC capability development.
Minimum Education, Experience and Skill Requirements: Education: • Bachelor's degree in a scientific discipline required; advanced degree preferred.
Experience: • Minimum of 10 years of experience in a GMP Quality Control laboratory environment within biotech or pharmaceutical organizations. • Demonstrated experience operating within a true QC organization, with a strong understanding of QC structure, controls, and GMP rigor. • Prior experience leading, mentoring, or managing QC laboratory staff. • Experience supporting GMP inspections, audits, and quality system activities impacting QC operations. • Strong interpersonal, leadership, and communication skills with the ability to partner effectively across functions. • Comfort working in a build-phase or evolving environment where systems and infrastructure are developing. • Proficiency with standard office software including Microsoft Word, Excel, and PowerPoint.
Must be authorized to work in US.We cannot provide sponsorships. *** NOTE: We are not accepting resumes from agencies. ***
