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Associate Director

Location: Cambridge
Posted on: April 6, 2021

Job Description:

Associate Director, Analytical CMC at Magenta Therapeutics 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 directly to the Head of Analytical & Formulation Development and will be responsible for managing analytical CMC and QC operations at Magenta. This includes interactions with external and internal stakeholders and oversight of phase appropriate method validation and tech transfer, stability, specifications, reference standards, and critical reagents. 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:

  • Partnering with internal and external stakeholders to define science-driven, phase-appropriate, and risk-based analytical development strategies to support programs from discovery through commercialization
  • Technical oversight of external vendors, including analytical tech transfer, implementation of specifications and stability protocols, and QC release and stability testing
  • Method qualification, validation, implementation, and lifecycle management
  • Stability strategy and planning across programs, including data tracking and trending
  • Critical reagent management, including inventory, supply, and qualification
  • Development of business processes, templates, standards, and/or procedures
  • Leading the specification development and documentation process, incorporating current and emerging industry concepts to improve the technical/scientific aspects of specifications
  • Delivering timely and impactful data and documentation to meet project milestones and associated regulatory requirements
  • Staying current with state-of-the art approaches and applicable global regulations and industry standards for analytical CMC
  • Maintaining a balanced use of internal and external (CMO/CRO) resources to ensure maximal efficiency and prioritization of programs
  • Interacting effectively with functional leads and other stakeholders across Magenta We would be thrilled if you brought the following with you:
    • PhD in a relevant scientific discipline with at least 8 years of industry experience in Analytical CMC and/or QC, with a focus on protein-based pharmaceuticals; candidates with a BS or MS degree and applicable experience are also encouraged to apply
    • Experience with analytical method development, phase-appropriate validation, and transfer of methods
    • Expertise in cell-based assays and understanding of how USP and other guidelines are implemented in the design of bioassays is a strong plus
    • Experience working with external vendors and in an environment that balances in-house and CRO capabilities to meet milestones for multiple projects
    • Understanding of unique challenges for non-mAb modalities such as bispecific antibodies and ADCs is a plus
    • Experience with development of business processes, procedures, and/or templates to guide analytical development and/or QC activities, including those related to method qualification/validation, stability, reference standard, specifications, and comparability
    • Knowledge of how analytical methods are maintained and evolve during the course of development
    • 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. 29 Newbury Street
        3rd Floor
        Boston, MA 02116
        P (617) 585-2000

Keywords: THIRD ROCK VENTURES, LLC, Cambridge , Associate Director, Executive , Cambridge, Massachusetts

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