Biotech Partners

Biologics Procurement Manager

Posted: 18 hours ago

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Job Description

Manager, Biologics Procurement & Manufacturing📍 Greater Atlanta Area (On-Site) 🕒 Direct Hire | Full-Time | PermanentWe are partnering with an established and highly respected medical device organization seeking a Manager of Biologics Procurement & Manufacturing to lead critical supply and training operations supporting biologics-based manufacturing.This on-site leadership role is responsible for ensuring uninterrupted supply of red blood cells and related blood products for production, while also overseeing GMP-compliant training programs for manufacturing personnel. The ideal candidate combines operational leadership, regulatory expertise, and hands-on experience in biologics or in vitro diagnostics manufacturing environments.Position OverviewThis role oversees two key functional areas:Biologics Procurement Operations – Ensuring consistent inventory levels and quality of blood-derived materials required for manufacturing.Manufacturing Training & Compliance – Designing, implementing, and maintaining GMP-aligned training programs, competency assessments, and regulatory compliance initiatives.You will lead departmental staff, drive operational excellence, and ensure adherence to Quality, GMP, ISO 13485, and regulatory standards within a medical device manufacturing environment.Key ResponsibilitiesBiologics Procurement & Inventory ManagementMaintain appropriate inventory levels of red blood cells and other blood-derived materials to meet production demands.Oversee daily operations of the Biologics Procurement department, ensuring efficiency and adherence to established protocols.Ensure proper handling, documentation, storage, and traceability of materials in accordance with GMP standards.Maintain a working knowledge of raw materials, product composition, biosafety considerations, and chemical hazards associated with Red Cell and Capture products.Ensure compliance with biohazard handling, disposal regulations, and environmental health and safety standards.Support process improvements, deviation investigations, and implementation of enhanced operational procedures.Manufacturing Training & CompetencyLead the development, coordination, and execution of manufacturing training programs.Oversee onboarding training, cross-training, and retraining initiatives in alignment with GMP and regulatory requirements.Conduct and document annual competency assessments for manufacturing personnel.Ensure training records are accurate, complete, and submitted in a timely manner to Learning & Development.Maintain current knowledge of GMP, ISO 13485, and IVDD manufacturing requirements.Contribute to the creation, review, and revision of SOPs and controlled documents.Leadership & Team ManagementDirectly supervise departmental staff, including scheduling and daily workflow oversight.Conduct interviews, provide performance feedback, and manage employee development and disciplinary actions when necessary.Ensure department operations are organized, audit-ready, and aligned with company objectives.Promote a culture of safety, accountability, collaboration, and continuous improvement.Maintain a clean, inspection-ready work environment and organized documentation systems.QualificationsExperience in biologics, blood products, cell culture, or in vitro diagnostic device manufacturing.Strong understanding of GMP and ISO 13485 regulatory requirements.Prior leadership or supervisory experience within a regulated manufacturing environment.Experience developing and delivering structured training programs.Knowledge of biologics lab equipment, maintenance protocols, and GMP-compliant operations.Strong documentation, organizational, and communication skills.

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