Jobs at Sekisui Diagnostics, LLC

Leads technical manufacturing teams across fermentation, downstream processing, and chromatography operations. Oversees process optimization, scale-up, continuous improvement, quality and regulatory compliance, deviations, CAPAs, change controls, risk assessments, audits, equipment qualification, capital projects, and new product introductions. Coaches production staff, collaborates with Engineering, Quality, Validation, and Process Development, and supports operational planning and budget activities.

Leads cross-functional teams and manages new product development and continuous improvement projects. Develops project plans, schedules, timelines, and deliverables; monitors progress, risks, and obstacles; implements mitigation strategies; communicates status and recommendations to stakeholders; and resolves challenges while balancing priorities. The role requires strong collaboration, influence, organization, and decision-making skills in an onsite diagnostics environment.

Supports large-scale manufacturing through production data analysis, process troubleshooting, resource planning, continuous improvement, validation, investigations, and quality activities. The role coordinates equipment commissioning, change controls, risk assessments, root cause analysis, capital projects, manufacturing transfers, and shutdown/start-up activities. It also supports fermentation, downstream processing, chromatography, inventory planning, batch record review, colleague training, and collaboration with Engineering, Maintenance, QA, Logistics, and Technical Operations.

Qualified Person responsible for ensuring biologic drug substance batches comply with UK/EU GMP, certify and release batches, support inspections/audits, maintain MIA(IMP), provide regulatory oversight, deliver cGMP training, mentor future QPs, and support continuous improvement and supplier/internal audits.

Perform quality control testing of raw materials, in-process samples, and finished goods; manage proficiency surveys and certifications; establish assay specifications and SOPs; investigate lab issues, review product workbooks for release, and support equipment calibration and lab administration tasks including OOS, NC, Change Controls and CAPA closure.