Senior Manager: Manufacturing- Downstream Bulk Drug Substance

About the role

As Senior Manager of Manufacturing, you will provide leadership and guidance to the team responsible for 24/7 manufacturing operations in downstream purification. In this vital role as a member of the Manufacturing Leadership Team, you will collaborate cross-functionally to enable the commissioning, qualification, start-up, and GMP operation of a new drug substance manufacturing facility. You will be accountable for coaching and developing Downstream Front-Line Managers, organizational design of the manufacturing team, workforce planning, hiring, onboarding, training, qualification, and development of staff to support safe, reliable, and compliant operations. The position will ensure personnel are appropriately trained and qualified in accordance with established training programs, procedures, and operational readiness requirements.

Responsibilities

• Provide leadership and manufacturing oversight for Commissioning and Qualification activities associated with downstream process systems, equipment, utilities, and supporting infrastructure.
• Partner with Engineering, Quality, Automation, Validation, Process Development, and project teams to review system designs, commissioning and qualification protocols, acceptance criteria, turnover packages, and supporting documentation to confirm that systems are safe, compliant, maintainable, and operationally ready.
• Ensure appropriate Manufacturing participation in design reviews, system walkdowns, factory and site acceptance testing, commissioning execution, equipment qualification, process demonstrations, water runs, engineering runs, and performance qualification activities.
• Support the identification, documentation, escalation, and resolution of equipment, process, automation, and facility issues identified during C&Q and start-up.
• Provide leadership and oversight for downstream chromatography column packing activities to ensure readiness for reliable GMP operations.
• Lead operational readiness activities required for successful facility start-up and transition to routine GMP manufacturing, including development and execution of readiness plans, establishment of operating procedures and standard work, completion of training and qualification activities, confirmation of materials and equipment availability, implementation of shift structures, and verification that manufacturing systems and support processes are prepared for operation.
• Establish and monitor readiness metrics, risks, dependencies, and action plans, ensuring that gaps are identified early, assigned to accountable owners, and resolved in alignment with project and manufacturing milestones.
• Ensure effective handover of qualified systems from the project organization to Manufacturing and establish sustainable processes for equipment ownership, system performance monitoring, troubleshooting, preventive maintenance coordination, and continuous improvement.
• Following facility start-up, be accountable for sustained manufacturing performance, including safety, quality, compliance, schedule adherence, operational reliability, workforce capability, and continuous improvement across downstream purification operations.
• Develop and retain a diverse and high performing team in alignment with operational readiness schedules to ensure successful start-up and commercial GMP operations.
• Mature the site’s safety and quality culture of the department and champion continued improvement.
• Collaborate as one team of all manufacturing support groups (Quality, Process Development, Engineering, Supply Chain, and network partners).
• Provide support to troubleshoot, identify, and resolve issues as needed and manage call coverage for 24/7 operation.
• Provide technical leadership for the investigation of deviations and the development of corrective actions.
• Develop and implement departmental strategy and plans that are aligned with the broader organizational strategy and deliver continuous improvement.
• Lead and support regulatory inspections for areas of responsibility including evaluating complex compliance issues and developing playbooks for the inspections.
• Deliver against organizational financial commitments while championing a lean philosophy.

Requirements

• Doctorate degree and 2 years of Manufacturing & Operations experience
• OR Masters degree and 6 years of Manufacturing & Operations experience
• OR Bachelors degree and 8 years of Manufacturing & Operations experience
• OR Associate’s degree and 10 years of Manufacturing & Operations experience
• OR High School diploma/GED and 12 years of Manufacturing & Operations experience
• AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

• Demonstrated managerial experience in a GMP manufacturing drug substance plant
• Demonstrated experience in applying Operational Excellence and Lean Manufacturing
• Cross-functional work experience in either Process Development, Quality or Engineering
• Excellent communication skills, drive, sense of urgency, energy level and problem-solving abilities
• Demonstrated ability to forge and maintain strong relationships with other functional areas
• Ability to effectively develop and coach staff and positively advance the culture of an organization