Jobs at August Bioservices, LLC

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.

Leads IT support operations, supervises support personnel, manages service tickets and performance metrics, and oversees infrastructure, endpoints, identity management, cybersecurity, asset inventories, vendors, and enterprise applications. Ensures technology services support office, manufacturing, laboratory, warehouse, and remote environments while meeting GxP, validation, quality, security, and regulatory requirements. Coordinates incidents, maintenance, upgrades, documentation, procurement, and service restoration.

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.

Manage and improve document control and archiving for Quality Assurance at a pharmaceutical CDMO. Create, proofread, format, route, and archive SOPs, batch records, and GMP documents in eQMS/MasterControl; support audits, train/onboard users, and drive documentation process improvements.

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 administration and continuous improvement of the site eQMS (primary MasterControl owner), manage change control, drive quality system KPIs and inspection readiness, supervise Document Control Specialist, author/maintain controlled documents, and support cross-functional quality initiatives, validation, and regulatory compliance.

Lead and manage microbiology QC laboratory operations including environmental monitoring, aseptic process simulations, testing of materials and drug products, data review, mentoring analysts, supporting development and scale-up, ensuring cGMP and regulatory compliance, preparing protocols/reports, and participating in cross-functional projects.

Lead analytical development for pharmaceutical products by designing and executing lab experiments, developing and validating HPLC and dissolution methods, ensuring GLP/GMP compliance, analyzing data, documenting results, mentoring junior scientists, and collaborating with cross-functional teams to support formulation, stability, and quality control testing.

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.

Support technology transfer of sterile drug products and biologics by analyzing development and manufacturing data, identifying process gaps, supporting scale-up/validation, writing technical documents (SOPs, protocols, batch records), collaborating with cross-functional teams, troubleshooting technical issues, and contributing to process optimization using DOE and QbD principles.

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.

The Senior Accountant leads the full financial close process, ensuring compliance, accuracy, and reporting. Responsibilities include financial oversight, regulatory compliance, and process improvement.