Senior Manager: Manufacturing - Downstream Bulk Drug Substance

Amgen•Holly Springs, NC

4d•Onsite

About The Position

Be part of Amgen's newest and most advanced drug substance manufacturing plant. The Amgen FleX Batch facility combines the latest in single use technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility not only features the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it also integrates sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. 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, the Senior Manager of Manufacturing will collaborate cross-functionally to enable the commissioning, qualification, start-up, and GMP operation of a new drug substance manufacturing facility. This role is responsible for coaching and developing Downstream Front-Line Managers who oversee staff supporting direct drug substance production. The Senior Manager will be accountable for the organizational design of the manufacturing team, including workforce planning, hiring, onboarding, training, qualification, and development of staff to support safe, reliable, and compliant operations. The role will ensure that personnel are appropriately trained and qualified in accordance with established training programs, procedures, and operational readiness requirements. The position will provide leadership and manufacturing oversight for Commissioning and Qualification activities associated with downstream process systems, equipment, utilities, and supporting infrastructure. Responsibilities will include partnering 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. The Senior Manager will 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. The role will also support the identification, documentation, escalation, and resolution of equipment, process, automation, and facility issues identified during C&Q and start-up. The position will also provide leadership and oversight for downstream chromatography column packing activities to ensure readiness for reliable GMP operations. Additionally, the Senior Manager will lead operational readiness activities for successful facility start-up and transition to routine GMP manufacturing. This includes 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. The position will 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. The Senior Manager will also 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, the Senior Manager will be accountable for sustained manufacturing performance, including safety, quality, compliance, schedule adherence, operational reliability, workforce capability, and continuous improvement across downstream purification operations.

Requirements

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

Nice To Haves

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

Responsibilities

Develop and retain a diverse and high performing team in alignment with operational readiness schedules to ensure successful startup 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
Provide leadership and oversight for downstream chromatography column packing activities, including planning, execution, qualification, troubleshooting, documentation, and readiness to support reliable GMP manufacturing operations.
Lead and support regulatory inspections for areas of responsibilities including evaluating complex compliance issues and developing playbooks for the inspections
Deliver against organizational financial commitments while championing a lean philosophy
Provide Manufacturing leadership and support for Commissioning and Qualification activities, including design reviews, system walkdowns, protocol execution, issue resolution, and equipment turnover
Lead operational readiness activities for downstream manufacturing, including procedures, training, staffing, materials, system ownership, and readiness assessments to support successful facility start-up and transition to GMP operations.