Senior Quality Control Scientist

Magenta Therapeutics

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Life Sciences QA/QC
  • Post Date: 05/24/2021
  • Website: magentatx.com
  • Company Address: 245 First St.; 4th Floor, Cambridge, MA, 02142

About Magenta Therapeutics

Headquartered in Cambridge, Mass., Magenta Therapeutics (Nasdaq:MGTA) is a clinical-stage biotechnology company developing therapeutics to reset the immune system in order to cure more patients with devastating and life-threatening diseases. This immune reset approach can be applied through stem cell transplant to multiple diseases, including autoimmune diseases, such as multiple sclerosis and systemic sclerosis; blood cancers, such as acute myeloid leukemia; and genetic diseases, such as sickle cell disease.

Job Description

Are you looking for a role with impact?

Magenta Therapeutics is a clinical-stage biotechnology company developing therapeutics to reset the immune system to cure more patients with devastating and life-threatening diseases. This immune reset approach can be applied through stem cell transplant to multiple diseases, including autoimmune diseases, such as multiple sclerosis and systemic sclerosis; blood cancers, such as acute myeloid leukemia; and genetic diseases, such as sickle cell disease.

Magenta’s comprehensive approach to precision immune system reset will transform many aspects of the transplant process, aiming to make it safer and more effective.  Our culture is fueled by a driven, passionate group of people committed to making a difference, seizing opportunities for maximum impact, and pursuing progress for the patients we seek to serve.

We are seeking an experienced scientist that is highly motivated to work in a science-focused, collaborative, and integrated organization. The incumbent will report to the Head of Quality Control and will be responsible for implementing analytical strategy at contract laboratories. method development and QC operations across all programs at Magenta, contributing to both research/discovery and clinical development projects. The successful candidate will also have the opportunity to participate in or lead initiatives and project teams. Our team is a place where the autonomy to chase an idea and drive innovative solutions are not just encouraged and supported but expected. If you are looking for a place where you can impact the actual strategy of your company while remaining close to the lab and the science, we would like to hear from you.

You are perfect for this role if you are engaged by and want to be responsible for:

    Driving Analytical Development and Quality Control operational efforts to transfer, qualify, and validate analytical methods at contract laboratories
    Establishing, reviewing, or approving GMP compliant documentation related to method performance, release and stability testing, sample handling, raw materials, environmental monitoring, and related areas
    Technical review and oversight of analytical and QC activities at external vendors, including analytical-related investigations and change controls
    Monitoring QC release and stability testing at CDMOs, including data management, trending, and review of analytical data for completeness and correctness
    Managing critical reagents and reference standards, including inventory, supply, and qualification
    Developing phase-appropriate QC capabilities, performance metrics, standards, templates, and procedures
    Staying current with state-of-the art approaches and applicable global regulations and industry standards for method development and QC testing
    Collaborating with Quality and other internal and external stakeholders to make science-driven, phase-appropriate, and risk-based decisions, and proactively identify gaps and design mitigation strategies

 

We would be thrilled if you brought the following with you:

    PhD in a relevant field with at least 5 years of experience or BS/MS with at least 14 years of industry experience in QC or analytical development
    Experience working with external vendors and in an environment that balances in-house and CRO capabilities to meet milestones for multiple projects
    Experience transferring methods to CDMOs and designing method qualification and validation protocols
    Experience with establishing late-stage methods and control strategies for small molecules and biologics
    Expertise in cell-based assays and understanding of how USP and other guidelines are implemented in the design of bioassays is a strong plus
    Hands-on experience with development and qualification of a variety of HPLC and CE-based methods
    Quality mindset and experience working with GMP documentation and supporting investigations
    Working knowledge of ICH and other regulatory guidelines and direct involvement with FIH and later-stage CMC regulatory submissions
    Effective communication, collaboration, and negotiation skills
    Demonstrated critical thinking, problem solving, and innovation capabilities

    Commitment to a high-performance, patient & people-first culture, where there is alignment around a common vision and individuals are supported in their growth path

Successful leaders and contributors within Magenta are:

    Driven.  You will be focused on the achievement of Magenta’s mission and major corporate goals.
    Results-focused.  Demonstrated record of exceeding stretch goals, and willing to bring creative problem-solving skills to challenges along the way
    Intuitive. You will enjoy learning and being involved in the content of our whole business, thriving on a very fast-paced and growing business
    Collaborative.  You will have demonstrated the ability to achieve objectives across complex projects and organizational structures
    Process-oriented, yet flexible. You will appreciate and be able to create and drive process, while also recognizing when flexibility is needed.
    Transparent and Articulate.  You will have the ability to communicate clearly and concisely with all stakeholders
    Independent. You will be able to self-organize and operate effectively without significant day-to-day oversight, while staying tightly connected to key leaders and teams across the company
    A role model for the company’s cultural pillars; Courage, Commitment & Excellence

At Magenta, we celebrate our differences. We value the power of a diverse array of folks who bring all of themselves to their work. We embrace cultural, cognitive, social, and professional diversity because we know the only way we’re going to make new cures possible is by working together.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.