Forge Biologics
Biotechnology
ScientistI,QCAnalytical(2ndShift)
“Scientist I, QC Analytical(2nd Shift) at Forge Biologics. Skills: Analytical method execution, Method qualification, Method validation, Troubleshooting, cGMP compliance. Perform in-process testing. Perform release testing”
Industry & Context.
Troubleshooting; Root cause analysis; OOS investigations
What They're Looking For.
Must Have
Bachelor's in relevant scientific field, Experience in nucleic acid-based methods, Experience in protein-based assays, Advanced knowledge of molecular biology techniques, Advanced knowledge of biochemistry techniques, Advanced knowledge of cell biology techniques, Proven ability to execute analytical assays, Proven ability to troubleshoot analytical assays, Proven ability to optimize analytical assays, Analytical data interpretation skills, Robust understanding of cGMP requirements
Nice to Have
Advanced degree preferred, Experience leading junior team members, Experience mentoring junior team members, Experience guiding junior team members
What You'll Do.
Perform in-process testing
Perform release testing
Perform stability testing
Execute nucleic acid-based methods
Execute protein-based assays
Perform advanced analytical testing
Perform cell-based infectivity assays
Perform potency assays
Perform viability assays
Support troubleshooting of processes
Support troubleshooting of assays
Represent QC during audits
Represent QC during inspections
Ensure effective qualifications
Ensure effective validations
Ensure effective transfer of methods
Contribute to authoring documentation
Review QC documentation
Conduct investigations
Determine root cause of OOS
Implement corrective actions
Implement preventative actions
Provide support for Deviations
Provide support for Change Controls
Provide support for CAPAs
Review GMP documentation
Approve GMP documentation
Drive development of analytical methods
Drive optimization of analytical methods
Drive validation of analytical methods
Provide technical guidance
Mentorship to junior team members
Compile data with minimal oversight
Archive assay results
Interpret assay results
Support regulatory inspections
Support client inspections
Support internal audits
Manage tracking of testing data
Manage trending of testing data
Lead laboratory investigations
Participate in laboratory investigations
How You'll Work.
Team & Collaboration
Partnering with Analytical Development
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