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 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.

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.

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.

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.

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.

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.

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.

Support GMP-compliant manufacturing by maintaining production documents, tracking raw materials and inventory, administering ERP/MRP, using eQMS for quality events, coordinating with purchasing, accounting and sales, maintaining production records/spreadsheets, and ensuring trained backfill and good housekeeping.

Lead plant-floor reliability efforts including root-cause analysis, FMEA, PdM program development (vibration, thermography, oil analysis, ultrasound), PM program ownership, asset lifecycle support, and reliability-driven capital projects. Supervise Engineering Technicians, partner with Maintenance, Quality, Validation, and Engineering to reduce unplanned downtime, close CAPAs, manage change controls on GMP equipment, and analyze CMMS data to prioritize reliability improvements.