Sr Scientist, Analytical - Immuno-oncology

Company: Michael Page
Location: Waltham
Posted on: October 2, 2021

Job Description:

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.

*Description*

* 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 manufacturing.

* 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 development

* Supervise research associates through regular coaching and guidance.

* 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 degradation pathway.

* Experience of analytical method development, qualification/validation, transfer and remediation.

* Familiar with biologics process and product development and clinical/commercial manufacturing.

* Breadth and depth in Analytical Chemistry, Biochemistry, Protein Chemistry, and Biophysics.

* Deep understanding of protein structure and function relationship

* 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 immunotherapies.

* Competitve base salary and benefit package

* Opportunity to lead team of talented researchers

* Join an innovative drug discovery start up

Keywords: Michael Page, Waltham , Sr Scientist, Analytical - Immuno-oncology, Other , Waltham, Massachusetts