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Biotech
The Research Associate leads oligonucleotide project development including synthesis and purification, ensuring compliance with SOPs and cGMP, while documenting results and supporting technology transfers.
Biotech
Support design, construction, commissioning, qualification, and turnover of capital projects for pharma/biopharma manufacturing. Manage project schedules and budgets, develop URSs, specify equipment/instrumentation, support tech transfer and scale-up, participate in FAT/SAT and IQ/OQ/PQ validation, and assist QA and EHS activities including PHA and PSMS compliance.
Biotech
Responsible for GMP automation and controls for biopharma manufacturing: design, troubleshoot, and optimize PLC/DCS/SCADA/BAS systems; lead control system specs, change controls, and Part 11 compliance; support validation (FAT/SAT/IQ/OQ); and collaborate with QA, validation, process, and manufacturing teams to ensure uptime and regulatory compliance.
Biotech
The Regional Lean Business Analyst supports lean deployment by engaging on manufacturing floors, providing analytical insights, building dashboards, and collaborating with site teams to improve operations and tracking mechanisms.
Biotech
Manage and deliver large integrated API manufacturing projects from concept to delivery. Lead cross-functional, multinational teams, develop cost models and proposals, maintain customer production schedules, ensure cGMP/regulatory compliance, support business development, collect client requirements, and drive process improvements across departments.
Biotech
Support ATD Project Managers to maintain project plans, Smartsheet trackers, KPIs, and documentation. Coordinate cross-functional teams, manage shipments (including APIs), ensure cGMP/process compliance, facilitate communications, and improve PM tools and workflows to deliver customer-focused nucleic acid manufacturing programs on schedule.
Biotech
Lead design, implementation, and maintenance of automation and control systems (PCS/SCADA, BAS, data historian) for GMP oligonucleotide manufacturing. Manage automation projects, contractors, and CQV activities to ensure data integrity, 21CFR Part 11 compliance, and successful start-up of control systems while supporting IT/OT networks and safety protocols.
Biotech
Lead technical aspects of upstream processes in an oligonucleotide production facility, focusing on equipment design and commissioning while ensuring compliance.
Biotech
The Process Engineer will lead downstream process design, equipment selection, and project management for oligonucleotide production, ensuring compliance and efficiency.
Biotech
Operate in a GMP oligonucleotide manufacturing environment to produce APIs, support technology transfer and scale-up, validate equipment, write/revise SOPs, collaborate with Quality/Validation/Engineering to resolve manufacturing issues, and maintain/calibrate critical process equipment while following regulatory and safety procedures.
Biotech
Support transfer and scale-up of processes from Chemical Development into GMP manufacturing. Author and review batch records, SOPs, change controls, deviations, CAPAs, and automated equipment methods. Troubleshoot process and equipment issues, lead investigations of major deviations, and coordinate with development, QA, vendors, and customers to meet production, quality, and regulatory requirements.
Biotech
Support GMP manufacturing operations: transfer and scale-up processes, write and review batch records, SOPs, and automated methods; manage change controls, CAPAs, RAs, and EVs; troubleshoot process/equipment issues; participate in project teams; coordinate technical transfers and batch summaries; assist QA with deviation investigations and root cause analysis.
Biotech
Support GMP manufacturing by transferring and scaling processes from development to production; create and review batch records, SOPs, and automated equipment methods; generate change controls, CAPAs, RAs, and EVs; troubleshoot process equipment; lead investigations of deviations; participate in project teams and technical transfers to ensure scalable, compliant manufacturing operations.
Biotech
Support manufacturing by transferring and scaling processes from Chemical Development, authoring and reviewing batch records, SOPs, change controls, and automated equipment methods. Lead troubleshooting, coordinate tech transfers, participate in project teams, investigate process deviations, and collaborate with QA, vendors, and customers to meet production, quality, and timeline objectives.
Biotech
Maintain and secure operational technology for GMP oligonucleotide manufacturing, including SCADA, PLCs, BAS, data historians, MES, Active Directory integration, and ESXi hosts. Interface with IT, support system integration, ensure data integrity and regulatory compliance, lead change controls, support vulnerability assessments, and coordinate vendor work to maximize OT reliability and resiliency.
Biotech
Lead technical transfer and scale-up of processes from Chemical Development to manufacturing. Author and review batch records, SOPs, change controls, and automated equipment methods. Support troubleshooting, deviation investigations, and QA assessments, coordinating with vendors, customers, and project teams to meet production, quality, and regulatory requirements.
Biotech
The SAP S/4HANA Domain Architect leads architecture decision-making for Finance or Supply Chain, focusing on enterprise architecture, integration alignment, and custom code strategy to support ERP modernization.
Biotech
Lead and execute R&D for enzymatic ligation and oligonucleotide processes, ensuring compliance and effective tech transfer from lab to large-scale production.
Biotech
The Principal Automation Engineer leads automation projects for pharmaceutical facilities, establishing system requirements and managing integration for manufacturing technologies.
Biotech
The Process Engineer will lead the design and implementation of manufacturing processes for oligonucleotide production, including equipment procurement, development of new unit operations, and ensuring compliance with safety standards.
