Product Technical Lead

13 hours ago

Cambridge, Massachusetts, United States Intellia Therapeutics, Inc. Full time
About the Role:

We are seeking a highly skilled Product Technical Lead to join our Small Molecule and Oligonucleotide Process Sciences team at Intellia Therapeutics. As a key member of our Technical Operations department, you will be responsible for developing and transforming genome editing development candidates into therapeutic products.

As the Product Technical Lead for Oligonucleotides and Small Molecules, you will represent the team in cross-functional discussions and contribute to late-stage technical strategy, including process validation and regulatory interactions. Your responsibilities will include coordinating and supporting Process Validation activities across modalities and assets, transitioning processes to commercial stage, and leading/ tracking continuous process verification for sgRNA and lipids.

You will also be responsible for building a system for process validation documentation, proceduralizing process validation efforts across modalities, and leading a process validation subteam. Additionally, you will support regulatory authoring across regions and lifecycle stages, prepare and review CMC documentation for INDs and BLAs (Module 3), and support regulatory interactions and response to regulatory questions (RtQs).

As a key member of our team, you will establish and oversee process development strategy for new modalities and technologies to support clinical development and commercial supply. You will also develop and implement strategy for tracking and trending of process performance to enhance predictability and inform process development and process strategy.

Key Qualifications:

We are looking for a highly motivated and experienced individual with a PhD in Chemical or Biomedical Engineering, Chemistry, or a related field, with 6+ years of experience in process development within a biotech or pharmaceutical company. Alternatively, a BS/MS with 11+ years of experience in process development within a biotech or pharmaceutical company is also acceptable.

Desired skills include experience with process development and GMP manufacturing for nucleic acids, and/or LNPs and its components, as well as experience in scale-up, process development, process characterization, and process validation for late-stage products. You should also have experience with regulatory submissions and processes, including query management, and be a strong technical writer and presenter with experience in writing technical documents, reports, and risk assessments.

Additional qualifications include experience in functional representation or matrix leadership within a cross-functional team, preferably a CMC team, and excellent organizational, documentation, and communication skills, as well as adaptive learning, critical thinking, and the ability to work well in a team.

About Intellia Therapeutics:

Intellia Therapeutics is a biotechnology company dedicated to developing curative genome editing treatments for severe and life-threatening diseases. Our mission is to positively transform the lives of people living with these diseases, and we are committed to excellence and innovation in all that we do.

We believe in the power of curiosity and pushing boundaries, and we welcome challenging thoughts and imagination to develop innovative solutions. We are driven to cure and motivated for change, and we are committed to making a difference in the lives of our patients and their families.

What We Offer:

We offer a dynamic and supportive work environment, with opportunities for professional growth and development. We are committed to diversity and inclusion, and we strive to create a workplace that is welcoming and inclusive for all employees.

We also offer a competitive compensation and benefits package, including medical, dental, and vision insurance, as well as a 401(k) plan and paid time off.

How to Apply:

If you are a motivated and experienced individual who is passionate about developing curative genome editing treatments, we encourage you to apply for this exciting opportunity. Please submit your resume and a cover letter outlining your qualifications and experience.

We thank all applicants for their interest in this position, and we look forward to reviewing your application.

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.

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