Intellia is seeking a motivated Analytical Development candidate for a position as Principal Scientist/Associate Director to join our AD team.  The primary responsibilities for this position include oversight of the bioassay functional group analytics and will require oversight of the transfer and qualification of assays to external testing sites, as well as the development of internal analytical capabilities to support in house process development.  This position is a leadership role that will both mentor and oversee junior staff and provide leadership for the development of internal analytical development process and technical capabilities.

Responsibilities: 

• Lead the bioassay analytics group and define its analytical strategy to ensure that it is scientifically sound, phase appropriate and incorporates industry best practices

• Oversee the development, qualification and validation of analytical test methods and technology transfer at outsourced Contract Research and Contract Manufacturing Organizations (CROs/CMOs), in accordance with ICH guidance documents, including management of associated deliverables and timelines

• Work closely with process development to ensure that an analytical strategy is developed for testing based on CQA identification, process control strategies as well as process development and characterization needs

• Work closely with, and supports quality control on investigations, OOS, OOTs and release assay trouble shooting

• Provide primary authorship of analytical sections for regulatory filings

• Provide strong knowledge, mentorship and technical leadership of analytical development processes to train junior staff and build in house analytical capabilities

• Lead the establishment of in-house systems and procedures to ensure adequate rigorous laboratory practices & regulatory requirements for analytical activities at its in-house facility

• Oversee the establishment of in-house infrastructure (Analytical equipment procurement/qualifications, preparation and maintenance of SOP’s, determination and control of critical reagents etc)

Qualifications:  

• Ph.D. in a biology, biochemistry, or related field and 8+ years of experience, or a Master degree or a Bachelor degree with 10+ years of experience in analytical development within a biotech/pharmaceutical development and/or manufacturing environment

• Expertise in the development of methods in an analytical development environment, with an understanding of regulatory requirements and trends related to analytics and product development; expertise in the analytical techniques required for AAV gene therapy is a strong plus

• Experience leading teams in the development, qualification/validation and tech transfer of analytical methods

• Full understanding of compliance and cGMP considerations.

• Excellent communication, writing, technical, organizational, leadership, and mentoring skills are required

• Must be a team player prepared to lead, work in, and embrace a team-based culture

• Proven troubleshooting, problem solving and investigational skills

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.