Scientist III (Bioassay)

Job DescriptionJob Description

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 https://www.pharmaron.com/careers/job-openings/ click US Job Openings, ref job Scientist III (Bioassay).