Associate Director, CMC/Contractor Management at Magenta Therapeutics
Cambridge, MA, US
Company Overview:
Magenta Therapeutics is a biotechnology company harnessing the power of stem cell science to revolutionize stem cell transplantation for patients with immune and blood-based diseases. By creating a platform focused on critical areas of transplant medicine, Magenta Therapeutics is pioneering an integrated approach to stem cell therapies to create patient benefits. Founded by internationally recognized leaders in stem cell transplant medicine, Magenta Therapeutics was launched in 2016 by Third Rock Ventures and Atlas Venture and is headquartered in Cambridge, Mass. For more information, please visit
About this position:
The Associate Director, CMC / Contractor Management is responsible for interfacing with contract manufacturing organizations for Magenta Therapeutics clinical development programs. This key position will establish and manage work plans to provide input and approval of process development projects, production projects and routine product manufacturing, in compliance with Magenta procedures, FDA regulations and those of other regulatory agencies. The successful candidate will substantially contribute to authoring CMC sections of INDs and other filings, while maintaining a constructive and cooperative relationship with contract manufacturing organizations, (CMOs), clinical site(s), contract research organizations (CROs) and in-house R&D/clinical translation teams. The role has broad responsibilities across CMC functions including process development, manufacturing, vendor oversight and QC review. The Associate Director, CMC / Contractor Management must have successfully demonstrated technical proficiency, scientific creativity, initiative, independent thinking and collaboration with others. This position reports to the Vice President, Regulatory and Quality.
Primary Responsibilities:
Direct day-to-day oversight for the Quality Operations of Magenta contract manufacturing of MGTA-456 cell therapy.
In conjunction with Magenta management and interfacing with CMO staff, input and approval for development of production processes, product specifications and method and process qualifications.
Author and assemble CMC sections of regulatory filing(s) as needed.
Write, review and approve SOPs, protocols, reports, etc as needed.
Periodically travel to CMOs, CROs and clinical site(s), to include vendor audits.
Demonstrated ability to collaborate with all functional areas in support of corporate objectives.
Demonstrated ability to lead CMO initiatives in accordance with corporate objectives.
Quality and Regulatory functions as well as functional leads to maintain alignment of goals and to navigate project obstacles.
Demonstrated skills in designing, executing and interpreting process and product development experiments.
Degree in a biology, biochemistry or related discipline with 5-10 years of relevant experience in biologics development including cell therapy development: PhD (preferred) with 5-10 years of relevant experience; or a BS/ MS with 15-20 years of industrial experience.
Experience from biotech/pharma strongly preferred.
Fundamental knowledge of cell biology, immunology, cell culture and cell cryopreservation principles.
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.
Strong analytical skills; performing statistical analysis a plus.
Breadth of knowledge across cell therapy technologies, cell therapy manufacturing, cell characterization method development, GLP/GMP experience, assay validation, Quality Systems and regulatory requirements.
Experience authoring CMC sections of regulatory documents.
Ability to perform up to 15% travel.
We offer competitive compensation along with a comprehensive benefits package. To apply, please submit your resume and include the job title in the subject of your email.