Scientist III (Bioassay)

Scientist III (Bioassay) for Pharmaron (Boston) Lab Services LLC to work at our Woburn, MA loc. Develop, troubleshoot, + optimize new assays based on client needs.

Write Validation Protocol + SOP. Develop plate maps for validation. Determine parameters for validation + acceptance criteria. Perf sci + tech review of validation data + reports.

Responsible for overall conduct of GxP projects, including sci + regulatory aspects.

In collaboration w/ Project management, serve as a point contact for client communication.

Notify QAU + Sponsor of any deviations that occur during validation, + participate in documenting + investigating deviation including participating in root cause investigations.

In collaboration w/ QA, confirm assay meets regulatory req standards, + approve Validation report + Sample analysis report.

Review audit reports, respond to audit findings, + ensure timely completion of any corrective + preventive actions.

Author + review Protocols, Reports, Deviations, + Audit responses.

Train Scientists on techniques + assays, + provide tech assistance to assigned research staff.

Oversee the work of up to three junior scientists.

Perf RUO + GxP assays independently.

Perf sample analysis following established SOPs under RUO/GLP/cGMP conditions.

Perf QC function to review data + reports to ensure accuracy of laboratory-related processes.

Provide high quality documentation of all lab related activities, including assay batch record + sample inventory.

Maintain regular communication w/ scientists, PIs, + other project staff as well as external clients.

Adhere to all lab standards as defined in each written SOP.

May undergo background checks incl drug screening.

Wage: $87,589 to $100,000.

Must have Bach in Biology, Biochem, Biomedical Engineering or rel sci field, 3 yrs rel exp working in a laboratory following GLP and cGMP regulations, and the following skills (3 yrs exp):

cell-based neutralizing Abs (Nab), Potency assays, ELISpot, or Flow Cytometry development and validation; and Microsoft Office, including Word, Excel, and PowerPoint.

In the alternative, must have Master's in Biology, Biochem, Biomedical Engineering or rel sci field, 1 yr rel exp working in a laboratory following GLP and cGMP regulations, and the following skills (1 yr exp): cell-based neutralizing Abs (Nab), Potency assays, ELISpot, or Flow Cytometry development and validation; and Microsoft Office, including Word, Excel, and PowerPoint.

In the alternative, must have PhD in Biology, Biochem, Biomedical Engineering or rel sci field.

Apply at click US Job Openings, ref job Scientist III (Bioassay).