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Senior Manager, CMC Operations

Employer
Intellia Therapeutics
Location
Cambridge, MA, United States
Start date
Mar 18, 2021

View more

Discipline
Manufacturing & Production, Operations, Science/R&D, CMC
Required Education
Other
Position Type
Full time
Hotbed
Genetown

Job Details

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.

The (Sr) Manager, CMC Operations will coordinate oversight and compliance of Intellia Process and Analytical Development Labs and provide sample management, logistics and coordinate analytical testing for samples and materials in support of internal and external process development. The (Sr) Manager, CMC Operations has experience in the use of project management tools (MS Project/Smartsheet) and principles and has the ability to manage and prioritize activities for multiple project teams from preclinical through clinical development to ensure projects stay on track and are within expected timelines. The candidate will also coordinate cross-functionally to ensure appropriate integration with broader project/program timelines and CMC strategy, tracking timelines and deliverables.

Responsibilities:

Laboratory Coordination:
  • Serve as primary point of contact for Lab Operations and IT to assist with lab relocation(s), and restructuring.
  • Develop, implement and maintain laboratory guidelines and standard operating procedures.
  • Develop and coordinate equipment maintenance and calibration program.
  • Track and manage inventory of long-lead process consumables and critical reagents for process development and pilot scale production.

Sample and Materials Management:
  • Manage and track development samples and materials inventory.
  • Lead coordination of non-GMP analytical sample testing and prioritization.
  • Manage logistics of non-GMP sample and materials transport between process development, analytical testing labs, CROs and external partners.
  • Review and approve SOWs for external process development sample testing.

Additional Responsibilities:
  • Responsible for documentation including but not limited to: agendas, meeting minutes, action items, dashboards, risk register, mitigation plan, decision logs, etc.
  • Support preparation and management of CMC budget(s). Act as point of contact for SOWs and contracts management.


Requirements:
  • Bachelor's degree in the life sciences (molecular biology a plus), chemical or industrial engineering, or equivalent required. MS in science a plus.
  • At least 8 years' experience in the biotechnology/pharmaceutical industry.
  • Prior experience in lab operations desired.
  • Proficient at prioritization and driving complex projects to milestone completion.
  • Ability to identify risks and escalate appropriately.
  • Strong communication skills both written and orally. Able to communicate project status in a clear and concise manner.
  • Experience working both independently and in a cross functional, team-oriented, collaborative high-pressure environment, is essential.
  • Strong leadership skills (persuasive, encouraging, and motivating).
  • Ability to work within a rapidly changing environment and to quickly adapt to new situations.


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.

Company

Many of us pursuing work in the biotechnology industry are inspired by a loved one who is living with a disease or the loss of someone in our community. Rare genetic and oncological and immunological diseases not only affect the people living with often debilitating and life-threatening symptoms, but these disorders also significantly impact their families, friends and caregivers.
 
Our researchers work tirelessly to harness the genome editing technology CRISPR/Cas9 for human therapeutic use. Jennifer Doudna, an Intellia co-founder, and Emmanuelle Charpentier were awarded the 2020 Nobel Prize in Chemistry for their pioneering work in CRISPR. We at Intellia are humbled to have a hand in making what we believe to be medical history. As a leader in this space, we take this responsibility to patients seriously.
 
We are employing a modular genome editing platform to create diverse in vivo and ex vivo pipelines, spanning a range of therapeutic indications. Guided by this full-spectrum approach, we are committed to making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to creating novel engineered cell therapies for various cancers and autoimmune diseases.

Change life stories with genome editing therapies!

Stock Symbol: NTLA

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Company info
Website
Phone
(857) 285-6200
Location
40 Erie Street
Cambridge
Massachusetts
02139
United States

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