Jobs at Scientific Protein Laboratories, LLC

Develops, scales up, optimizes, and transfers biopharmaceutical manufacturing processes from lab/pilot to commercial GMP production. Prepares PFDs, mass balances, protocols, and SOPs; executes engineering batches; supports equipment qualification (IQ/OQ/PQ), troubleshooting, CAPAs, validation, and training. Collaborates cross-functionally and with CDMO clients while ensuring cGMP and regulatory compliance.

Supervise on-site QA activities for cGMP API manufacturing including raw material inspection/release, batch record review, investigations, deviations, change controls, CAPAs, product release, audit support, and continuous improvement of quality systems. Manage QA staff, training, metrics, and regulatory compliance.

Supervise daily cGMP API manufacturing shift operations, ensuring safety, quality, and on-time production. Oversee personnel, review batch records and documentation for ALCOA+ compliance, escalate deviations, support investigations and audits, coordinate with cross-functional teams, and lead continuous improvement and troubleshooting efforts.

Manage and execute Quality Systems QA activities including GMP training, review/approval of validation and qualification documents, investigations, deviations, change controls, CAPAs, APR preparation, and audit coordination and response.

Drive reliability improvements for cGMP pharmaceutical manufacturing by performing RCA/FMEA, optimizing PM programs, developing predictive maintenance, managing asset lifecycle, supervising engineering technicians, leading reliability capital projects and change control, and analyzing CMMS data to reduce unplanned downtime and eliminate repeat failures.

Manage and maintain the manufacturing training program and LMS to ensure cGMP compliance. Develop curricula with SMEs, schedule onboarding/refresher training, track qualifications, generate compliance reports, support audits, maintain training SOPs/records, evaluate effectiveness, and drive continuous improvement and digitalization initiatives.

Support GMP-compliant production by managing production documents, tracking raw materials and inventory, administering ERP/MRP and eQMS, coordinating with Purchasing, Accounting and Sales, maintaining production records and spreadsheets, and assisting with process and document updates to ensure timely, compliant manufacturing operations.

Lead maintenance reliability initiatives for GMP pharmaceutical manufacturing: implement PM/PdM programs, perform RCA/FMEA, manage asset lifecycle, supervise technicians, analyze CMMS data, and drive reliability capital projects and change control.

Lead and document investigations of manufacturing deviations and OOS events, implement CAPAs, author and maintain SOPs and batch records, support audits and validations, perform root-cause analysis (5 Whys, Fishbone, FMEA), monitor process metrics, drive continuous improvement, and ensure cGMP compliance across manufacturing operations.

Lead development and continuous improvement of a company-wide GxP and non-GxP training management system. Design curricula and learning pathways, manage training data and LMS processes, ensure GxP compliance with Quality, monitor qualification status, drive training effectiveness evaluations, analyze capability gaps tied to quality events, and support HR on learning initiatives and audits.

Administer, configure, validate, and continuously improve the electronic Quality Management System (eQMS) and Electronic Batch Records (EBRs). Support EBR lifecycle, system integrations, data integrity (ALCOA+), reporting, CSV activities, user support, training, audits, and regulatory compliance (21 CFR Part 11, EU Annex 11). Collaborate with Manufacturing, Quality, and IT to maintain compliant workflows, access controls, and dashboards.

Develop, maintain, and troubleshoot Rockwell PLC and HMI programs (ControlLogix/CompactLogix, FactoryTalk View SE, PlantPAx) in a cGMP pharmaceutical environment. Ensure documentation, validation (IQ/OQ/PQ), data integrity (21 CFR Part 11/ALCOA+), and collaborate with Production, Quality, and Engineering to optimize automated systems and support capital projects.

Lead on-site QA activities including batch record review, product release, investigations, CAPA execution, and IPC oversight. Provide cross-functional GMP guidance, support audits/inspections, report quality metrics, and manage and develop QA teams to ensure compliance and continuous improvement of quality systems.

Lead pancreatin (wet processing) manufacturing operations ensuring cGMP compliance, production scheduling, quality, safety, and efficiency. Supervise staff, manage batch execution and documentation, support CAPAs/deviations, audits, regulatory inspections, continuous improvement, KPI and budget oversight, and cross-functional collaboration to meet production and customer requirements.