Associate Director/ Director, Attribute Sciences

Location
Cambridge, MA, United States
Posted
Nov 10, 2020
Ref
4910637002
Required Education
Doctorate/PHD/MD
Position Type
Full time

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 a mass spectrometry expert to build and lead an attribute sciences group. This role will report into the Head of Analytical & Formulation Development and will be responsible for protein characterization, developability, and bioanalytical efforts to support research and development programs at Magenta. 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:

  • Defining and leading the attribute sciences team within the Analytical & Formulation Development organization to meet the expanding needs of Magenta's portfolio including discovery and clinical programs
  • Leading the overall scientific, technical, and operational efforts related to protein and small-molecule characterization, developability, and bioanalytical methods
  • Partnering with the translational sciences and in vivo pharmacology groups to oversee the development of bioanalytical methods at external GLP laboratories to support non-clinical and clinical studies
  • Design and development of an LC/MS bioanalytical platform for biological samples to support internal studies and tech transfer to external GLP laboratories
  • Driving structure/function studies and other characterization activities, including in vivo CQA analysis, to advance product and process understanding
  • Science-driven, phase-appropriate, and risk-based analytical development strategies and business processes related to comparability, reference standard, CQAs, and analytical controls
  • Building scientific knowledge, capabilities, and strategies in molecular characterization to inform program decisions from discovery though product registration
  • Delivering timely and impactful data and process knowledge to meet project milestones and associated regulatory requirements; this includes the design of protocols, execution of experiments, and reporting and documenting data in characterization reports
  • Establishing and building internal capabilities and tools for rapid characterization of product quality from discovery through registration
  • Identifying and establishing partnerships with external vendors to leverage capabilities not available in-house.
  • Staying current with state-of-the art approaches and applicable global regulations and industry standards for product and process characterization and bioanalytical methods
  • Participating or leading effectively in internal projects and external collaborations by representing the analytical & formulation development organization as needed
  • 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
  • Developing staff and providing input into personnel decisions including performance appraisals, promotions, hiring, and mentoring


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

 

  • PhD in a relevant scientific discipline
  • At least 10 years of experience and exposure to all stages of biologics development, including late-stage clinical development and preparation for product registration
  • Demonstrated track record in product characterization utilizing mass spectrometry and related technologies for a variety of biologics modalities including but not limited to fusion proteins, bispecifics, mAbs, ADCs, and small molecules
  • Experience developing and validating bioanalytical methods, including LC-MS platforms, for clinical and non-clinical sample analysis
  • Direct experience in CMC analytical and regulatory requirements, including development of control strategy to support late-stage product development and readiness for process characterization and registration submissions
  • Proven leadership ability to align, motivate, and empower team members
  • Experience working in an environment that balances in-house and CRO capabilities to meet milestones for multiple projects
  • Demonstrated critical thinking, problem solving, and innovation capabilities
  • Effective communication, collaboration, and negotiation skills
  • 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.