Manager, CMC Process Analytics
Are you looking for a role with impact?
Magenta Therapeutics is a company dedicated to addressing significant needs across all aspects of transplant medicine with a culture fueled by an amazing, passionate group of people committed to the idea of “patients first” and making a difference. We started with an idea— Significant needs remain for patients living with autoimmune diseases, blood cancers, and rare genetic diseases. Bone marrow transplant is a potential cure for many, but its high risks, toxic side effects and complexity prevent many patients from being able to benefit. Magenta is working comprehensively to change the transplant journey for patients. By pioneering an innovative portfolio of novel therapeutics designed to make the entire bone marrow transplant process more effective, safer and easier, we aim to unleash the full potential of bone marrow transplant for those living with a wide array of conditions such as multiple sclerosis, scleroderma, acute myeloid leukemia, myelodysplastic syndromes, inherited metabolic diseases, and sickle cell disease.
The people at Magenta are at the very core of our progress in pursuing this vision. Our roles don’t dictate our daily activities – every employee is empowered to make an impact, seize opportunity and to develop skills and expertise.
We are looking for a Manager, of CMC Process Analytics to be responsible for leading process and analytics optimization for Magenta Therapeutics clinical development programs. This key position will establish and manage work plans to analyze process data from Phase II/III studies as well as manage external process and assay development in compliance with FDA regulations and those of other regulatory agencies. This role will provide the opportunity to advance state of the art Cell Therapies through late stage clinical development and into commercialization.
The successful candidate will manage a constructive and cooperative relationship with contract manufacturing organizations (CMOs) and in-house R&D/clinical translation teams. The role has broad responsibilities across CMC functions including process development, assay development, data analysis, vendor oversight and QC. Our successful Manager, CMC Process Analytics must have the desire and history of demonstrated technical proficiency, external team management, initiative, independent thinking and collaboration with others.
You are perfect for this role if you are engaged by and want to be responsible for:
- Analyzing production process data to identify trends and correlations with human clinical outcomes.
- Developing, qualifying and validating assays for clinical product with an emphasis on flow cytometry methods for both in process and product release testing.
- Overseeing the on-going development of production process, product specifications and qualifications, to provide for sound production practices and robust methods/techniques which establish product characterization, identity, purity, potency, sterility, etc.
- Collaborating with Quality and Regulatory functions as well as functional leads to maintain alignment of goals and to navigate project obstacles.
- Support CMC section preparation for regulatory filing(s) as needed.
- Periodically traveling to CMOs.
We would be thrilled if you brought the following with you:
- PhD in bioengineering, biochemistry or related discipline with 2-5 years (or BS/MS degree with 5-10 years) of relevant experience. Experience in biologics development including cell therapy development preferred.
- Strong analytical skills to perform statistical analysis as well as proficiency in Excel
- Fundamental knowledge in cell biology, immunology, cell culture and cell cryopreservation principles
- Breadth of knowledge across cell therapy technologies, cell therapy manufacturing, cell characterization method development, GLP/GMP experience, assay validation, Quality Systems and regulatory requirements
- Demonstrated skills in designing, executing and interpreting experiments
- Working knowledge of flow cytometry, ELISAs, cytokine assays, compendial methods for cell and gene therapy, including sterility testing required; chromatographic/mass spec methods a plus
- Experience authoring CMC sections of regulatory documents a plus
- Ability to perform up to 20% travel
To be successful as a leader and contributor within Magenta, you must be:
- 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.
- Entrepreneurial. You will enjoy learning and being involved in the content of our whole business, thriving on a very fast-paced and growing business.
- Intuitive. You will have a demonstrated ability to work in the “gray zone” and anticipate challenges before they arise.
- A proven cross-functional leader. You will have demonstrated the ability to “influence without authority,” build teams, and achieve objectives across complex projects and organizational structures.
- Process-oriented, yet flexible. You will appreciate and be able to create and drive process, and at the same time recognize when rules are meant to be bent.
- Transparent and Articulate. You will have the ability to communicate clearly and concisely with all stakeholders.
- Enterprise-focused and Business-savvy. You will always seek to put the goals of the company first, and help others understand the tradeoffs we need to make across the business. You’ll also be interested in new business development opportunities, being able to bring those to the attention of the right teams at Magenta and able to support those activities as requested.
- 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