Jobs at August Bioservices, LLC

Leads review and approval of analytical reports, methods, protocols, specifications, and data packages supporting release testing and stability studies. Supports analytical method development, validation, transfer, qualification, and lifecycle management for drug substance and drug product programs. Participates in investigations of deviations, OOS, and OOT events while ensuring cGMP and regulatory compliance. Drives improvements in analytical reporting, data integrity, documentation quality, and operational efficiency.

Manage end-to-end enterprise IT projects involving ERP, laboratory, manufacturing, quality, and regulated GxP systems. Coordinate stakeholders across IT, engineering, manufacturing, quality, validation, laboratory operations, vendors, and implementation partners. Responsibilities include project planning, budgeting, scheduling, governance, risk and dependency management, vendor oversight, validation documentation, executive reporting, and transition to operational support.

The Financial Controller leads accounting operations, financial reporting, close processes, cash flow, treasury, compliance, audits, internal controls, and finance team development. The role also supports forecasting, pricing, cost accounting, ERP initiatives, financial systems integrity, and scalable accounting processes while partnering with manufacturing, R&D, operations, and commercial teams in a biotech manufacturing environment.

Deliver and coordinate GMP/GDP training and onboarding for manufacturing personnel, conduct hands-on qualifications for core processes, support aseptic training and observations, maintain MasterControl training records, assist audits, and improve training effectiveness to ensure compliance and inspection readiness.

Lead cross-functional projects in a CDMO environment from development through manufacturing. Define timelines, budgets, resource needs, manage scope changes, ensure on-time delivery, drive process improvements, coordinate stakeholders, and support client interactions and visits.

August Bioservices is a high-growth CDMO seeking to attract talent for dynamic opportunities. Applicants are encouraged to submit resumes for future openings.

Develop and maintain detailed production schedules for sterile pharmaceutical manufacturing, balancing suite, equipment, labor, materials, quality, and client constraints. Coordinate with Manufacturing, Quality, Supply Chain, Warehouse, Engineering, and Client Services to optimize capacity and meet delivery commitments. Manage schedule changes, maintain accurate ERP and batch genealogy data, report adherence and utilization metrics, and support root-cause analysis, CAPA, S&OP, and cGMP compliance.

The Project Engineer ensures operability of GMP manufacturing equipment and collaborates on design, commissioning, and troubleshooting. Responsibilities include project management for equipment procurement and technical documentation.

Owner of equipment reliability and asset-performance improvement for manufacturing systems. Lead RCAs, develop reliability strategies, specify and verify equipment modifications, optimize preventive/predictive maintenance, build reliability metrics/dashboards, and drive cross-functional implementation within cGMP-regulated manufacturing.

Supervise AQL and Quality on the Floor teams to provide real-time GMP oversight of manufacturing. Manage staffing, coaching, scheduling, and performance; ensure inspections follow procedures; support investigations, deviations, CAPAs, batch review, audits, and regulatory compliance; track QA metrics and drive continuous improvement with Manufacturing and cross-functional partners.

Support quality aspects of new client product transfers into manufacturing and labs. Lead technology transfer from clients, coordinate cross-functional stakeholders, identify CMC risks, develop mitigation strategies, support batch documentation, change control, audits/inspections, and ensure GMP and regulatory compliance throughout project lifecycles.

Lead and establish a company-wide continuous improvement program to drive operational readiness, schedule adherence, and execution discipline across Manufacturing, Quality, Supply Chain, and other functions. Coordinate cross-functional dependencies, implement readiness reviews and escalation mechanisms, track schedule adherence and documentation performance, and develop dashboards and management cadences to improve execution reliability in a regulated sterile injectable manufacturing environment. Influence organizational alignment, drive root-cause improvements, and support scaling through standardized operational systems and accountability frameworks.

Lead technology transfer and process implementation for sterile drug products and biologics, collaborating across R&D, production, quality, and regulatory. Conduct process development, scale-up, DOE studies, equipment selection, technical writing (SOPs, batch records, protocols), training, troubleshooting, and QbD-driven optimization to ensure successful fill/finish operations.