Director, Cell Therapy Process Development

Location
Cambridge, MA, United States
Posted
Jul 30, 2021
Ref
R215
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
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 with Intellia:

Are you a deeply motivated, experienced technical leader in cellular therapy process development looking for the opportunity to join a cutting-edge company and drive a high-performing team rooted in science and engineering of cell therapies? As a Director of Cell Therapy Process Development, you will be joining our Tech Ops team as a leading member of our growing CMC team. In this key role you will provide a critical contribution to the overall development, technical operations, in-process analytical development needs as well as mentorship for a talented and motivated CT team. You will be directly responsible to lead and develop robust, scalable, reproducible and high-quality manufacturing processes for Intellia's ex vivo pipeline. You will be a strong voice in our partnership with external CDMOs and internal R&D teams and will be experienced in tech transfer activities including risk management evaluations and gap assessments to ensure secure drug product supply. You will play a key role supporting possible regulatory filings as we advance our ex vivo products into the clinic.

Main responsibilities include:
  • Grow and maintain a high-performing team including hiring, training, staff assignment, coaching, mentoring, developing relevant metrics and performance management.
  • Lead your team of scientists and engineers to develop and continuously improve robust cellular manufacturing processes and control strategies using principles of QbD and risk management
  • Provide technical leadership in process development, optimization and troubleshooting of cell therapy processes, (LOVO, CliniMACS, Prodigy, Sepax, Xuri) internally and at CDMO partners, and lead the evaluation and implementation of automation and closed processing technologies
  • Review and approve applicable product batch documentation, including batch records, testing data, change controls and deviations
  • Work in lockstep with Supply Chain, Quality, Finance, and external vendors to identify and secure critical raw material inventory, testing specifications, Quality/Supply agreements, and operate within budgetary constraints.
  • Be a strong contributor to define regulatory strategy and to author and review technical documents including CMC regulatory sections for cell manufacturing
  • Support corporate strategies for development activities for cellular product pipeline, including project planning, timelines, milestones, and financial/budgetary elements within the CT PD function.


About you:

Are you a proven leader with a passion for cellular therapies ready to change life stories with genome editing technologies? Qualifications and desired skills include:
  • PhD degree in life sciences or engineering with 6+ years, Masters with 10+ years or Bachelor's degree with 12+ years experience. Master's degree preferred.
  • Demonstrable expertise and experience in cellular drug substance process development and tech transfer (preferably TCR/CART) including the use of QbD principles is required in the context biotech or pharmaceutical industry or service
  • Prior formal DOE experience is a plus, as is experience with process characterization studies and late stage clinical/ process performance qualification
  • Proven track record of 4+ years of managerial experience motivating, influencing, resolving conflict and managing stakeholders
  • Embrace the core Intellia values of One, Explore, Disrupt, Deliver to make gene editing therapies a reality, today


Meet your future team:

You will lead a growing team of talented, passionate, collaborative cell process scientist and engineers that define and optimize Intellia's portfolio of ex vivo products. We are accountable for the successful handover from Research, including manufacturability assessments, to then develop (and tech transfer to CDMO partners) robust, scalable reproducible manufacturing processes and in-process monitoring to ensure product quality, including safety and potency through all stages of clinical development. The team supplies study material for pre-clinical development and analytical development teams as well as support Intellia's ex vivo emerging pipeline from pre-candidate nomination through late stage clinical and ultimately to commercialization activities as cellular manufacturing and engineering SMEs.

In this key leadership role, you will report directly to the Vice President, Cell Therapy and Viral Vector Process Development, who embraces a culture of trust, respect and collaboration so that each team member can reach their full professional and personal potential.

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.