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Manufacturing Technical Lead
2 months ago
Responsibilities:
Review GMP-executed manufacturing batch records
Revision of controlled documents including, but not limited to, SOPs, MBRs, and BOMs
Document, input, and upload manufacturing data and production efforts in appropriate logs, forms, reports, and databases
Work with the Quality team through owning, investigating, and writing deviations; creating and executing CAPAs; writing and managing Change Controls; authoring out of specification (OOS) and investigation reports
Train, coach, and develop Manufacturing Associates
Work effectively with cross functional teams, including but not limited to, Process & Analytical Sciences, MSAT, QC, QA, Supply Chain, CMC Operations, Facilities, etc.
Support and/or lead Commissioning and Validation activities
Maintain equipment operation through responsive troubleshooting, repairs, and following operations guidelines
Provide hands-on technical, organizational, and leadership expertise to the manufacturing department
Support cGMP manufacturing of TScan cell therapy products while adhering to cGMPs, SOPs, compliance/regulatory mandates, safety procedures, and quality requirements
Requirements:
High School Diploma or GED required, at minimum
8-10+ years of experience in cGMP manufacturing in the biotech or pharmaceutical industry required
Prior cell therapy manufacturing experience highly desired
Skilled in aseptic techniques and processing
Proven track record of owning, investigating, and writing deviations, creating and executing CAPAs, and writing and managing Change Controls
Strong technical writing and oral communication skills
Must be able to lift and transport (using carts or wheelies) packages weighing up to 50 pounds
Extensive walking throughout the facility will be required
Must be able to use a company-issued computer and have at least intermediate skills in Microsoft Word, Excel, Outlook, and PowerPoint programs needed to perform job
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