Sterile Injectable Manufacturing Manager

Halo Pharmaceutical is a technology-focused contract manufacturing business with differentiated applications and capabilities in solid, semi-solid and liquid dosage forms, with a particular focus on controlled substances. Halo has long-standing commercial relationships with a number of major pharmaceutical companies and maintains facilities in both the United States and Canada.

Our family of companies offers complete CDMO services including custom synthesis of intermediates, reference standards, drug substances and drug product manufacturing. Halo Pharma is part of Noramco. We are stronger together!

The Sterile Injectable Manufacturing Manager is a senior operational and technical leader responsible for overseeing all aspects of sterile fill/finish manufacturing operations within a cGMP-compliant pharmaceutical contract development and manufacturing organization (CDMO). This includes but is not limited to formulation, filling (vials/syringe/cartridge), visual inspection and secondary packaging. Products will be a mix of branded and Gx and types of sterile injectable dosage forms across many therapeutic areas.

This role ensures continuous improvement, optimal capacity utilization, regulatory compliance, and delivery performance while maintaining a strong focus on safety, quality, cost, and customer satisfaction. The position requires a highly technical and operational leader capable of understanding and assisting with equipment qualification, media fills and process validation, leading complex investigations, implementing continuous improvement initiatives, and managing cross-functional capital and operational projects.

The Sterile Injectable Manufacturing Manager serves as a critical link between front-line aseptic operations and senior leadership, reporting to the Director of Operations.

• Lead and manage all sterile injectable manufacturing operations to ensure safe, compliant, and efficient aseptic production. Ensure the department meets production schedules, customer delivery commitments, and financial targets for the new fill/finish line.
• Develop and manage capacity models, manufacturing scheduling, and utilization plans to optimize throughput and asset performance. Manage departmental budgets and control operational costs in alignment with site financial targets.
• Collaborate with Supply Chain, Production Planning, and Project Management to align sterile manufacturing capacity with client demand forecasts and technology transfer timelines. Ensure operational readiness including staffing, training, gowning qualification, and equipment availability.
• Maintain Tier boards and drive KPI performance visibility for aseptic manufacturing operations. Establish performance goals aligned with site strategy and conduct performance reviews aligned to strategic direction.
• Lead and execute capital projects, sterile line expansion initiatives, and operational improvement projects. Develop project timelines, budgets, and deliverables. Coordinate cross-functional project teams and participate in client project meetings, providing sterile manufacturing expertise and representing fill/finish capabilities.
• Actively contribute to the development and revision of SOPs, batch records, work instructions, and training materials reflecting aseptic best practices and current regulatory requirements.
• Lead, mentor, and develop a team of manufacturing operators, technicians, and supervisors, fostering a culture of aseptic discipline, accountability, and continuous improvement.
• Support business development efforts by providing technical input for sterile proposals, client tours, capability assessments, and technical feasibility evaluations.
• Drive Continuous Improvement initiatives utilizing Lean Manufacturing, Six Sigma, and Continuous Improvement methodologies specific to aseptic fill/finish operations.
• Lead productivity improvement, waste reduction, fill rate optimization, and OEE improvement programs for the sterile line.
• Promote a culture of aseptic discipline across the sterile manufacturing suite.
• Lead root cause investigations and implement effective CAPAs related to sterile manufacturing deviations, environmental excursions, and product quality events.

• Provide technical leadership for aseptic fill/finish manufacturing processes, including isolator operations, stopper bowl feeding, fill weight control, stoppering,…