Associate / Director, Process Development

Company: Myeloid Therapeutics
Location: Cambridge
Posted on: May 13, 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 Assoc./Director, Process Development. The role title will be commensurate to education and experience in relevant fields. This role will lead the Process Development Team at Myeloid, that is responsible for the development, qualification and transfer of phase appropriate processes to support IND-enabling studies and clinical development. The team is also performing a variety of diligence to support Manufacturing. This position will work closely with multiple 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:

--- Build, grow and lead the Process Development group to develop and qualify phase-appropriate processes for biologics and cell & gene products, including engineered immune cells and lipid nanoparticle/nucleic acid cargos
--- Build in-house capabilities to develop a range of to enable and/or optimize the manufacturing of the company's products
--- Establish process development strategy with senior leadership and oversee execution.
--- Build business and operational processes to enable high-level of team performance to deliver on process development life cycle and pilot production support.
--- Develop processes, unit operations, draft Standard Operating Procedures and Batch records, establish Bill of Material, and lead internal technology evaluation activities.
--- Lead the design and execution of development studies, author protocols and reports that support the development of DS and DP, critical material, equipment specifications and control strategy.
--- Develop process qualification/validation and comparability strategies
--- Contribute to Tech transfer plans and execution.
--- Represent the Process Development function in cross-functional and external -facing activities including at contract vendors and facilities, provide technical leadership for technical transfer, implementation and investigation, working with cross-functional team.
--- Use statistical analysis tools and DoE to understand process performance, define operating ranges and establish relevant process controls. Compile and analyze data using established methodologies.
--- Lead efforts for identification, testing, and implementation of innovative technologies to improve manufacturing efficiency
--- Support technical oversight of contract manufacturing facilities for technical transfer, process implementation and production.
--- Contribute to investigations of quality events associated with GMP manufacturing and testing.
--- Identify, qualify, and manage raw material according to regulatory standards
--- Own process development sections and contribute to regulatory filings and associated diligences (IND, etc..)
--- Report on progress, establish timelines, organize, analyze, interpret and communicate data to key stakeholders and provide technical recommendations to management
--- Any other duties as assigned to support the current needs of the organization.

Qualifications and Education

--- Ph.D. in molecular/cell biology, biochemistry, immunology, virology, bioengineering, biopharmaceutical development or related life sciences field with 7+ years of relevant industry experience in biologics process development, cell & gene therapy process development, or equivalent experience, eg. MS with 10+ years.
--- Hands-on experience with several of the following process areas: immune cell isolation, closed systems, enrichment, transduction, expansion and cryopreservation, electroporation, lipid nanoparticles, purification, fill/finish, formulation, media development, raw material selection, culture systems, DoE, PAT, operation range definition.
--- Demonstrated experience as group lead and 3+ year of team management.
--- Proven track record developing and optimizing processes for the manufacturing of biologics products or cell & gene therapies including yield, quality, cost of goods reduction, scale-up and scale down models employing multiple technology platforms.
--- Experience in project management
--- Solid and up-to-date knowledge of phase-appropriate process development requirements and Regulatory Agencies' guidance, including for Biologics and Cell & Gene Product development.
--- Direct experience with optimizing and qualifying/validating cell and/or biologics production processes and tech transferring them to contract testing facilities
--- Good understanding of statistical principles supporting and evaluating process performance and comparability
--- Experience with hematopoietic derived cell products and/or nucleic acid/ lipid nanoparticle is preferred
--- Experience working cross-functionally with process qualification/validation and quality functions, in GXP settings.
--- 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
--- Attention to detail and careful record-keeping
--- Excellent organizational skills and ability to manage multiple projects
--- 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 , Associate / Director, Process Development, Executive , Cambridge, Massachusetts