Associate / Director, Process Development
Company: Myeloid Therapeutics
Location: Cambridge
Posted on: May 13, 2022
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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
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