Senior Director, Quality Control

Intellia Therapeutics

Intellia Therapeutics

Sales & Business Development, Quality Assurance
Cambridge, MA, USA
Posted on Friday, August 4, 2023

Why Join Intellia?

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.

We want all of our people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.

How you will Achieve More:

As the Senior Director Quality Control (QC), you are responsible for establishing new analytical and environmental monitoring QC labs at Intellia’s future clinical manufacturing facility. This will also include leading the QC policies, strategies, method transfers, method qualifications/validations, and testing operations for that site. Additionally, you will manage contracted external testing sites to ensure the work is efficient, on time, on budget, and executed with highest quality as well as, driving continuous improvement initiatives to maintain compliance with regulatory requirements. You will provide technical and compliance leadership while collaborating closely with Intellia’s Contract Testing Organizations (CTOs) and Contract Manufacturing Organization (CMOs) QC partners. This position is expected to work in a highly collaborative and cross-functional team environment interfacing with Analytical Development, Quality Assurance, Process Development, CMC and Project Management, and Technical Operations Teams. In the leadership role of Senior Director of QC, you will be responsible for hiring, mentoring and the career development of the QC team members. Key responsibilities include:

  • Provide strategic direction and leadership to the QC function and implementation of CMC control strategies, including environmental monitoring & microbial controls, raw materials testing, compendial testing, in-process testing, release and stability testing of cell and gene therapy products.

  • Direct phase-appropriate assay transfer, assay qualification, and validation activities

  • Collaborate with other Tech Ops stakeholders in Process and Analytical Development, Quality and Regulatory to set appropriate product specifications, develop comparability strategies and support manufacturing investigations

  • Support and follow on with critical technical Out Of Specifications (OOS) /Trend (OOT) Investigations

  • Author and review relevant sections of CMC documentation in support of INDs, CTAs, BLA submissions, amendments, and briefing documents

  • Participate in internal and external audits and ensure timely closure of audit findings

  • Provide leadership to the QC team, including hiring, mentoring, career progression and developing staff members to ensure projects are adequately staffed

  • Contribute to Quality budget planning and approve proposed budgets for supporting teams and sub-functions

About You:

  • PhD in Chemistry, Biology, Bioengineering or related field with 10-15+ years of relevant industry experience. BA and/or MS with an equivalent combination of education and work experience are considered

  • 7-10+ years of managing GMP functions, vendor relations and technical professionals

  • Experience establishing QC laboratories in new build environments

  • Expertise in phase-appropriate GMP testing, and Lab Operations of cell/gene therapies or biologics

  • Expertise in qualification, validation, transfer and life cycle management of analytical methods

  • Experience in Health Authority Inspections, related observations and implementation of CAPAs

  • Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines with excellent time management and organizational skills

  • Proven track-record to collaborate effectively in a cross-functional matrix environment and lead with curiosity and influence across functional and organizational lines

Meet the Team:

This role reports directly to the Vice President of Quality. You will be leading a team who are passionate about quality control and patient-centric. The QC team is critical in supporting Intellia’s advancing pipeline of multiple cell and gene therapy programs. At Intellia we believe genome editing has incredible potential to treat and cure life-threatening and fatal diseases, and in this role, your contributions will be essential to that effort.

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.