Senior Manager, AAV Process Development
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 At Intellia:
Are you a skilled and highly motivated Senior Process Engineer with leadership experience and expertise in AAV production in suspension systems at a 50L+ scale? Are you eager to establish a new function within a team of talented professionals in a rapid growth genome-editing company with a drive to make a difference in patients’ lives? We are seeking a senior process engineer with leadership experience to be accountable for our AAV Scale-Up and non-GMP Production Teams. Activities support our internal process development team, our R&D and in vivo testing teams, and our Analytical Development department. This is an essential internal- and external-facing role within our Viral Vector Process Development team and collaborative Technical Operations organization as we advance our growing pipeline of ex vivo and in vivo gene therapies.
The position requires oversight of Intellia’s internal Vector Production Core, as well as optimization and scale-up of AAV production requiring a solid understanding of HEK293 cell growth and transfection in stirred-tank reactors, recovery unit operations and viral purification technologies as well as process-monitoring analytics. Teamwork, versatility, and strong communication and problem-solving/analytical skills are a must.
Key responsibilities include:
Lead and grow internal Viral Vector Core services and team including establishing relevant performance indicating metrics
Key accountability for AAV process scale-up and optimization based on QbD for multiple AAV serotypes in transfection based processes;
Drug substance and drug product generation at 50L scale to support internal and CRO activities
Identify and define critical process parameters and support technology transfers to CDMOs and strategic partners working closely with process development and MSAT teams
Coordinate production activities and related analytics with internal stakeholders and manage and timely communicate results and timelines with the goal to meet critical milestones with multiple dependencies
Author standard operating procedures, development batch records and scale-up process development protocols/ reports; define relevant metrics to measure process
Provide expertise and guidance on developments and innovation in clinical scale AAV production to stakeholders across the organization;
Grow and maintain a collaborative high-performing team including hiring, training, coaching, mentoring of direct reports and foster an environment in which each is empowered and enabled to deliver results
Team is accountable to operate and maintain production scale bioreactors and a portion of other shared laboratory instruments.
Bachelor’s Degree in Biochemical Engineering, Molecular Biology, or Virology with at least 10 years of hands-on industrial experience, or MS with 8+ years of industry experience.
Managerial experience of direct reports in motivating, influencing, resolving conflict performance management and in managing stakeholders
Substantial work experience in suspension cell culture transfection process scale-up, and stirred tank bioreactor operation, including perfusion systems; Normal Flow (depth filtration) and Tangential Flow Filtration (TFF) for Ultrafiltration/Diafiltration (UF/DF); chromatography based purification with resins and other media.
Experience with Biologics Process Development, Technology Transfer to external CDMO, MSAT and/or Manufacturing in Cell & Gene technologies is required
Experience with viral vector analytics is a plus (e.g. CE-SDS, ddPCR, ELISA).
Effective inter-department coordination to meet project goals and timelines.
Must be a highly organized, detail-oriented, and self-starter who continuously seeks innovative solutions.
Excellent verbal and written communication skills
Meet your future team
In this role, you will be part of the AAV Process Development team, with key specialized functions. You will lead and further build a team of process engineers and process development professionals that 1) provide small scale vector core services for internal users 2) establish and optimize scale-up and to 50L process in order to tech transfer to external CDMOs 3) provide 50L-scale drug substance/ drug product supply for internal analytical and research needs. You will join the growing, collaborative and passionate Tech Ops team we advance our in vivo (VV) pipeline products using CRISPR genome-editing technologies. You will report directly to 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.
Covid-19 Vaccination Policy: Effective Monday, January 3, 2022, all Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. Requests for exemption for medical or sincerely held religious beliefs will be considered.
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.