MPI does not discriminate on the basis of race, color, religion,
sex, sexual orientation, gender identity or expression, national
origin, age, disability, veteran status, marital status, or based
on an individual's status in any group or class protected by
applicable federal, state or local law. MPI encourages applications
from minorities, women, the disabled, protected veterans and all
other qualified applicants.
* Build the state-of-the-art protein analytics and
characterization infrastructures, workflow, procedures and
capabilities for future growth.
* Conduct internal research effort and process/product
development to enable preclinical, tox, clinical, and
commercialization activities including candidate
selection/discovery, clone selection, cell line, upstream and
downstream, formulation, and fill/finish development.
* Develop phase appropriate, qualify/validate and transfer both
in-process and release analytical methods and transfer to internal
QC, or external CDMO for early and late stage clinical
* Design scientific-sound and risk-based control strategies
including drug substance and drug product specifications to ensure
the quality of clinical and commercial supplies.
* Review and author lab reports, technical reports, regulatory
filings, and external scientific presentations/publications.
* Represent the department in global project and program teams
to ensure the integration of the CMC deliverables into the
progression of pipeline molecules at different stages of
* Supervise research associates through regular coaching and
* Collaborate closely with other research groups and project
teams to achieve program goals
* Manage and work with CDMO proactively to ensure the timeline
and quality of the work.
* Represent the group in a variety of settings including
departmental and divisional meetings, and internal and external
collaborations about the direction and status of the department
* Ph.D. or equivalent with a strong track record of
contributions to recombinant biopharmaceutical development through
scientific publications and regulatory filings.
* Minimum 0-2 years of industry experience with biologics/large
molecule analytics and characterization of primary structure,
high-order structure, post-translational modification, and
* Experience of analytical method development,
qualification/validation, transfer and remediation.
* Familiar with biologics process and product development and
* Breadth and depth in Analytical Chemistry, Biochemistry,
Protein Chemistry, and Biophysics.
* Deep understanding of protein structure and function
* Strong background with analytical, biochemical and biophysical
technologies/instrumentation such as UPLC, HPLC, mass spectrometry,
capillary electrophoresis, light scattering, DSC, ELISA, protein
particle analysis, rheometer, UV-VIS, FTIR and automation.
* Excellent communication skills in both written and verbal and
ability to balance big picture and fine technical details.
Our client is a startup immunotherapy company located in Waltham
MA, established to pioneer the next generation of
* Competitve base salary and benefit package
* Opportunity to lead team of talented researchers
* Join an innovative drug discovery start up