Jobs at Scientific Protein Laboratories

Develop, scale up, optimize, and transfer biopharmaceutical manufacturing processes from lab/pilot to commercial GMP production. Prepare PFDs, mass balances, protocols, SOPs, and validation activities (IQ/OQ/PQ). Support troubleshooting, CAPAs, equipment selection, technical reporting, training, and cross-functional project work while ensuring cGMP and regulatory compliance.

Supervise on-site QA Operations staff to inspect manufacturing/testing, verify critical process steps, manage deviations/investigations/CAPAs, support regulatory functions, maintain cGMP quality systems, coordinate training and shift coverage, and provide on-shift QA decision-making and metrics reporting.

Supervise on-site Quality Assurance activities for cGMP API manufacturing, including inspections, batch record review, raw material release, investigations, deviations, change controls, CAPAs, product release decisions, audit support, and QA metrics reporting. Manage QA staff, training, procedures, and continuous improvement to maintain compliance with FDA/ICH/USDA/ISPE standards.

Perform metrology and calibration of production, research, and QC instruments to maintain cGMP compliance. Write calibration SOPs and technical reports, train junior staff, manage the Calibration and Metrology Information System, oversee third-party calibrations, and develop calibration procedures for new and existing equipment.

Administer, configure, validate, and support the electronic Quality Management System (eQMS) and Electronic Batch Records (EBRs). Manage integrations, ensure data integrity and regulatory compliance (21 CFR Part 11, EU Annex 11, ALCOA+), develop reports/metrics, provide user support/training, execute CSV activities, and support audits and remediation in a cGMP biopharma environment.

Lead design, implementation, and continuous improvement of company-level GxP and non-GxP training systems, curricula, and learning pathways. Coordinate training planning, maintain training records and systems, ensure regulatory compliance with Quality, monitor qualification status, analyze capability gaps tied to quality events, and drive training effectiveness and cross-functional alignment to support operational compliance in a regulated biopharmaceutical manufacturing environment.

Supervise daily cGMP manufacturing operations for pancreatin production, ensuring safe, compliant, and timely execution of batches. Oversee personnel, review batch records, enforce documentation integrity (ALCOA+), coordinate with Quality/Maintenance, lead shift activities, support investigations, and drive continuous improvement.

Ensure cGMP-compliant manufacturing through deviation investigations, CAPA management, authoring and maintaining SOPs and batch records, supporting audits and validations, performing root-cause analysis (5 Whys, FMEA), driving continuous improvement, and collaborating with QA, QC, Engineering, and Supply Chain to maintain product quality and regulatory compliance.

Develops, administers, and maintains manufacturing training programs to ensure cGMP and regulatory compliance. Manages LMS and training records, coordinates onboarding and refresher training, develops SOP-based curriculum with SMEs, tracks qualifications and compliance metrics, supports audits, and drives continuous improvement of training processes.

Execute and maintain quality systems for a cGMP biopharmaceutical site, including GMP training, review/approval of validation and qualification documents, managing investigations/deviations/CAPAs, change control, audit coordination/response, APR preparation, and continuous improvement projects.

Develop, maintain, and troubleshoot Rockwell PLC and FactoryTalk HMI/PlantPAx systems in a cGMP pharmaceutical environment. Ensure compliance with FDA 21 CFR Part 11 and ISA-88, produce revision-controlled documentation, support validation (IQ/OQ/PQ), collaborate with Production/Quality, and advise on automation for capital projects.

Lead pancreatin wet-processing manufacturing to meet production, quality, safety, and schedule targets under cGMP. Oversee frontline staff, batch execution, documentation, audits, deviations/CAPAs, continuous improvement, KPIs, budgets, and cross-functional collaboration.

Drive reliability improvements for cGMP pharmaceutical manufacturing equipment through failure analysis (RCA, FMEA), PM optimization, predictive maintenance (vibration, thermography, oil analysis, ultrasound), asset lifecycle support, supervision of engineering technicians, and leadership of reliability-driven capital and change-control projects to reduce unplanned downtime.

Manage on-site QA operations for cGMP API manufacturing: supervise QA teams, lead investigations and CAPA, perform batch record review and product release, support audits/inspections, and drive quality system continuous improvement and cross-functional compliance.