Immunogenicity Research Scientist / Manager
Company: Pharmaron
Location: Woburn
Posted on: January 27, 2023
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Job Description:
The Immunogenicity Research Scientist/Manager will work as part
of a team in a laboratory environment to complete client/Sponsor
driven projects. Scientist will be responsible to develop and
validated GxP immunogenicity assays for Biologics and CGT. This is
a remote role with 20% travel required.
Primary responsibilities include:
* Performing Scientific Review for project reports in area of
expertise.
* Serving as a team leader and/or Principal Investigator (PI) and
leading the technical, scientific, budgetary, and regulatory
aspects of development and validation of cellular and humoral
immunogenicity assays including GxP studies.
* May have up to five direct reports and working as a group leader
and/or Senior Manager.
* Demonstrating broad knowledge in the related technical area and
functioning as a subject matter expert and technical leader both
within and outside of the department.
* Write SOPs, validation protocols, and reports
* Overseeing project timelines and putting best efforts into
increasing productivity.
* Representing the company in scientific conferences or
participating in sales meetings as required.
* Working with management and QAU to maintain and improve quality
systems.
* Authoring and reviewing Protocols, Reports, Deviations, and Audit
responses.
* Providing leadership, mentoring, and training to assigned
scientific staff.
* Performing a QC function to review data and reports to ensure the
accuracy of all laboratory-related processes.
* Maintaining regular communication with QAU, scientists, PIs, and
other project staff and becoming the client's technical point of
contact for an assigned project or program.
* Additional duties and responsibilities as required.
Job Qualifications and Requirements:
* BS with at least 8 years of relevant experience, MS with at least
5 years of relevant experience, or PhD with at least 2 years of
relevant experience.
* Experience with immunoassays and cell based assay techniques like
ELISA, Flow Cytometry, ELISpot, MSD, WB is critical.
* Experience with validating cellular and humoral immunogenicity
assays under GxP regulations including basic statistical analysis
is required.
* Ability to quickly acquire new skills and craft creative
solutions.
* Must be detail oriented with the ability to multi-task and work
as part of a team to complete projects.
* Strong oral and written communication skills and the ability to
work without supervision in a team environment. Will participate in
client meetings.
* Excellent computer skills are required. Must be proficient in
Microsoft Office including Word, Excel (formulas, graphs and
charts), and PowerPoint.
Keywords: Pharmaron, Boston , Immunogenicity Research Scientist / Manager, Executive , Woburn, Massachusetts
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