Senior / Manager, Quality Control

Company: Myeloid Therapeutics
Location: Cambridge
Posted on: August 2, 2022

Job Description:

Company Overview: -Myeloid Therapeutics is an immunology company -focused on combining biology insights with cutting-edge technologies to harness myeloid cells and eradicate cancer and other diseases. -With broad clinical applications possible, the Company is presently advancing its cell therapy product candidates, derived from its ATAKTM -platform technology, with initial applications in T cell lymphoma and a primed monocyte approach to treating glioblastoma. The ATAKTM platform is scalable to multiple treatment modalities and to other disease areas. Company was founded based on technology from the laboratories of Ronald Vale and Siddhartha Mukherjee and includes a blue-ribbon syndicate of investors led by Newpath Partners. Myeloid Therapeutics is headquartered in Cambridge, MA.Position Summary:

• We are looking for a talented, collaborative, and experienced Sr./Manager, Quality Control. The role title will be commensurate to education and experience in relevant fields. This role will lead the Quality Control function at Myeloid, that is responsible for the quality testing of raw material, intermediate, Drug Substance/ Drug product and stability to support IND-enabling studies and clinical trials, and validation of test methods. QC activities are largely outsourced, and this position is principally external facing, working closely with CMOs and contract test labs performing a variety of analyses to qualify processes and materials, and release testing products. This position will also work closely with multiple internal R&D and CMC groups. This position offers a unique opportunity to have a key role in a well-funded startup with blue chip investors, field-leading founders and advisors, and a highly experienced biotech team. The position will be located in Cambridge, MA.Responsibilities:
  • Lead the Quality Control function to enable external QC testing of biologics and cell & gene products, including engineered immune cells and lipid nanoparticle/nucleic acid cargos
  • Implement and oversee GMP QC testing at external lab for raw material, in-process, Drug Substance/ Drug product release, Stability and process qualifications
  • Represent the Quality Control function in cross-functional and external -facing GXP activities at contract vendors and testing facilities, provide technical leadership for quality control, analytical transfer, QC testing, comparability, investigation and auditing.
  • Establish Quality Control strategy with senior leadership and oversee execution.
  • Lead analytical investigations of quality events (OOS, OOT, Deviations, etc..) associated with GMP manufacturing and QC testing, as required.
  • Build business and operational processes to enable reliable and high-level of performance to deliver on QC testing and analytics lifecycle.
  • Manage documents and material according to regulatory standards
  • Contribute to the design and manage execution of stability programs and raw material programs.
  • Co-lead method qualification and/or validation, working closely with Analytical Development.
  • Conduct data analysis in multiple formats, manage and review test data and documentation obtained for compliance to SOP and specification.
  • Author protocols, reports, revise Standard Operating Procedures and other documentation for quality testing and qualification/ validation to support the development of DS, DP and critical reagents.
  • Perform technical diligence on systems and technologies to ensure up-to date, compliant practices, and capabilities.
  • Provide training and technical leadership to less experienced staff, as needed.
  • Use statistical analysis tools to establish or revise relevant system suitability criteria and data trending.
  • Contribute to investigational drug development diligences to support regulatory filings (IND, etc..)
  • Report on progress, produce timelines, organize, analyze, interpret, and communicate data to key stakeholders and provide technical recommendations to senior management Qualifications and Education
    • BS. in molecular/cell biology, biochemistry, immunology, bioengineering, pharmaceutics development, or related life sciences field with 7+ years of relevant industry experience in biologics, cell & gene therapy analytical or Quality Control, or equivalent GXP experience, eg. MS with 5+ year.
    • Hands-on experience with several of the following techniques: molecular and analytical chemistry separation and characterization techniques, nucleic acids assays, SDS-PAGE, ELISA, Western blot, flow cytometry, immunoassays, and cell- based functional assays, in a GXP environment.
    • Direct experience managing or providing technical oversight of contract test labs and/or facilities and handling investigations.
    • Excellent attention to detail and record keeping, in paper-based or electronic quality systems. Direct experience with Good Documentation Practice (GDP) documentation and work execution forms.
    • Proven track record in method qualification/validation for cell & molecular-based assays in GXP settings
    • Experience executing test methods for biologics products or cell& gene therapies including identity, purity and potency.
    • Experience in project management
    • Solid and up-to-date knowledge of phase-appropriate Quality Control requirements and Regulatory Agencies' guidances, including for Biologics and Cell & Gene Product development.
    • Good understanding of statistical principles supporting and evaluating method performance and robustness, and data trending.
    • Experience with hematopoietic derived cell products is preferred
    • Knowledge/ or hands-on experience in nucleic acid/ lipid nanoparticle is preferred
    • Strong ability to multi-task and willingness to work effectively in a fast-paced environment and highly collaborative environment as a team player with a strong work ethic.
    • Strong problem-solving skills
    • Excellent organizational skills and ability to execute on multiple workstreams.
    • Excellent oral and written communication skills, able to write technical reports and protocols and work effectively as a member of a multidisciplinary team
    • Flexible team player excited to collaborate with internal and external partners
    • Authorized to legally work in US

Keywords: Myeloid Therapeutics, Cambridge , Senior / Manager, Quality Control, Executive , Cambridge, Massachusetts