Senior Manager Manufacturing Programs- Process Owner Organization

BioSpace; Holly Springs (NC); On-site; USD 140,000 - 200,000; Full time

Job summary

Amgen is seeking a Senior Manager of Manufacturing Programs to lead the Process Owner organization within Manufacturing Support at ANC. This role provides technical process stewardship, governance, and manufacturing change control support across Upstream, Downstream, and Services Drug Substance operations.

The Senior Manager will guide Process Owners, ensure operational readiness, and drive continuous improvement while expanding the swing-shift team for enhanced coverage and guidance across

Qualifications

• Doctorate or higher in biotechnology/pharmaceuticals with leadership experience.
• Extensive experience (8+ years) in biopharma manufacturing operations.
• Proven ability to lead Process Owner teams and manage programs in GMP environments.
• Experience with digital manufacturing systems and quality systems integration.

Responsibilities

• Lead and develop the Process Owner organization for Upstream, Downstream, and Services Drug Substance operations.
• Provide coaching, mentorship, and career development for Process Owners.
• Establish swing-shift Process Owner team to expand coverage and support.
• Drive safety, quality, compliance, collaboration, and continuous improvement.
• Oversee manufacturing change controls, CAPAs, and SOP governance.
• Coordinate with Quality, Engineering, Process Development, C&Q, Supply Chain, and Digital Manufacturing.

Skills

Process ownership

Leadership

GMP manufacturing

Cross-functional leadership

Digital manufacturing

Quality systems (EBR/MES)

Manufacturing governance

Operational readiness

Education

Doctorate degree in biotechnology/pharma

Master's degree in biotechnology/pharma

Bachelor's degree

Associate degree

High school diploma

Tools

Veeva

Documentum

EBR systems

MES

Job description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior Manager Manufacturing Programs

Live

What You Will Do

We are seeking a Senior Manager ofManufacturing Programsto lead the Process Owner organization within Manufacturing Support at ANC. This leadership role is responsible for providing technical process stewardship, manufacturing support, process governance, and manufacturing changecontrolsupport for Upstream, Downstream, and Services Drug Substance Unit Operations.

The Process Ownerteamserves as the technical process steward for manufacturing operations, partnering closely with Manufacturing Operations and cross-functional support functions to ensure manufacturing processes are effectively governed, implemented, maintained, and continuously improved throughout their lifecycle.

Process Owners serve as the primary technical liaisons between Manufacturing Operations and support organizations including Quality, Engineering, Process Development, Commissioning & Qualification (C&Q), Supply Chain, and Digital Manufacturing. Through floor presence,hypercaresupport, process ownership, operational readiness activities, and manufacturing change implementation, the team enables reliable, compliant, and efficient manufacturing execution.

The Senior Manager will lead a growing organization of Process Owners responsible for process ownership, floor support andhypercareactivities, operational readiness assessments, dry and water run execution, electronic batch record implementation support, manufacturing change implementation, BOM support, and procedural governance. This role will also be responsible for expanding organizational capabilities, including establishing and leading a swing-shift Process Owner team to provide enhanced operational support and manufacturing coverage.

• Lead and develop the Process Owner organization responsible for providing technical process stewardship and manufacturing support for Upstream, Downstream, and Services Drug Substance Unit Operations.
• Provide direct management, coaching, mentoring, and career development for Process Owners.
• Develop and implement a swing-shift Process Owner organization to provide expanded manufacturing support and floor coverage.
• Foster a culture of safety, quality, compliance, accountability, collaboration, operational excellence, and continuous improvement.
• Provide strategic leadership for process ownership, operational readiness, manufacturing change implementation,manufacturing procedures, manufacturing CAPAs,and technical process stewardship.
• Coordinate with site scheduling to ensure Process Owners provide timely hyper-care support and technical assistance during manufacturing campaigns, startup activities, process changes, first-time executions, and routine operations.
• Serve as the primary interface between Manufacturing Operations and support organizations including Quality, Engineering, Process Development, C&Q, Supply Chain, and Digital Manufacturing.
• Oversee execution of dry runs, water runs, engineering runs, and operational readiness activitiessupporting manufacturing.
• Own manufacturing-relatedCAPAs andchange controls associated with process, procedural, and operational improvements.
• Provide leadership andinputfor electronic batch record (EBR) and manufacturing execution system (MES) implementation activities impacting manufacturing operations.
• Partner withTechnologyteams to ensure manufacturing processes are effectively translated into digital workflows and manufacturing execution platforms.
• Partner with Supply Chain organizations to ensure manufacturing processes, material strategies, and Bill of Materials(BOM) support efficient manufacturing execution.
• Provide process ownership oversight for BOM creation, maintenance, and updates associated with manufacturing process changes.
• Ensure creation, revision, maintenance, and periodic review of GMP documentation supporting manufacturing operations.
• Drive strategic initiatives to improve process reliability, manufacturing efficiency, operator experience, and operational performance.
• Support inspection readiness activities and represent the Process Owner organization during audits and regulatory inspections as required.

Win

What We ExpectofYou

Basic Qualifications:

• Doctorate degree and 2 years of biotechnology or pharmaceutical industry experience
• Masters degree and 6 years of biotechnology or pharmaceutical industry experience
• Bachelors degree and 8 years of biotechnology or pharmaceutical industry experience
• Associates degree and 10 years of biotechnology or pharmaceutical industry experience
• High school diploma / GED and 12 years of biotechnology or pharmaceutical industry experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications

• 8+ years related work experience in biotechnology or pharmaceutical manufacturing with progressively increasing responsibility.
• Prior people leadership experience managing and developing technical teams.
• Strong understanding of GMP manufacturing operations supporting Upstream, Downstream, and Services Drug Substance Unit Operations.
• Experience with process ownership, manufacturing support, and technical process stewardship.
• Experience supporting digital manufacturing systems, electronic batch records (EBRs), manufacturing execution systems (MES), and associated process implementation activities within a GMP manufacturing environment.
• Experience authoring, approving, and governing manufacturing SOPs and GMP documentationwithinQuality Systems (i.e. Veeva,Documentum, etc.).
• Experience leading manufacturingCAPAs/change controls and implementation activities.
• Experience supporting operational readiness activities, including dry runs, water runs, process implementation, and startup support.
• Experience partnering with Supply Chain organizations to support BOM management, material readiness, and manufacturing execution.
• Excellent organizational, written, verbal communication, and cross-functional leadership skills.