Manufacturing Training Specialist Manufacturing Support

BioSpace; Holly Springs (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

Amgen is building its most advanced FleXBatch drug substance plant and seeks a Manufacturing Training Specialist 5 to lead training strategy, qualification planning, and readiness governance across ANC-1 and ANC-2 startup activities. The role collaborates with Quality, Engineering, and Supply Chain to ensure ongoing startup and operational excellence.

The position emphasizes floor leadership, CAPA execution, and the rollout of the Wake Tech LMS migration, with a focus on manufacturing workforce

Qualifications

• PhD or equivalent with biotechnology ops experience.
• Advanced degree in chemistry, biology, or engineering preferred with hands-on training.
• Extensive experience in biotech operations and qualification planning.

Responsibilities

• Lead manufacturing training strategy and qualification pathways for ANC-1/ANC-2.
• Own and govern training-related CAPAs and continuous improvement initiatives.
• Coordinate with Quality, Engineering, Validation, and Supply Chain to align readiness milestones.
• Develop and deliver technical training programs, including LMS migrations.
• Coach teams on GMP, safety, and operational excellence.

Skills

Hands-on problem solving

GMP compliance

Cross-functional collaboration

Training delivery

Curriculum development

Education

Doctorate degree

Master's degree in chemistry/biology/engineering + 3 years biotech ops

Bachelor's degree + 5 years biotech ops

Associates + 10 years biotech ops

High school diploma + 12 years biotech ops

Tools

Learning Management Systems (LMS)

Job description

HOW MIGHT YOU DEFY IMAGINATION?

YOUVEWORKED hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience,and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over10 million patientsworldwide. Come do your bestworkalongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleXBatch 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.

Manufacturing Training Specialist Manufacturing Support

The Manufacturing Training Specialist 5 serves as a senior individual contributor within the Manufacturing Support organization, providing technical leadership and operational support to ensure safe, compliant, and efficient manufacturing training operations across the site, with clear accountability for manufacturing workforce readiness and startup readiness outcomes.

Reporting to the Senior Manager of the MFG Support technical training team, this role serves as a site subject matter expert for manufacturing training processes, training effectiveness, and continuous improvement programs. The position requires significant floor presence and broad partnership with Manufacturing, Quality, Engineering, Supply Chain, HR, and Continuous Improvement teams to drive training readiness, operational performance, and quality improvement in a 24/7 manufacturing environment.

Organizational Impact

The Manufacturing Training Specialist 5 is a technical leader who strengthens manufacturing capability, enhances training effectiveness, and advances operational excellence across the organization. Through cross-functional collaboration, ownershipof qualification planning and execution, readiness metric governance, and leadership of training-related CAPAs and continuous improvement initiatives, this role directly supportsANC-1 and ANC-2 startup readiness, operational readiness milestones, andthe delivery of high-quality medicines to patients.

Key Responsibilities

Training and Capability Development

• Develop and execute the manufacturing training strategy for ANC-1 and ANC-2, ensuring alignment with businessobjectives, operational readiness requirements, compliance expectations, and workforce capability needs.
• Create, implement, and continuously mature the Training Assignment Portfolio (TAP) for ANC-1 and ANC-2 toestablishrole-based qualification pathways,own qualification planning and execution,improve training effectiveness, and support sustainable operational performance.
• Develop andmaintaintrainingand workforcereadiness governance tools, metrics, and reporting processes tomonitortraining compliance, qualification status,staffing readiness, procedural readiness, and overall manufacturing startupreadiness.
• Identifyreadiness risks and gaps through metric review, stakeholder input, and floor engagement, then drive mitigation actions to protect operational readiness milestones, engineering runs, validation execution, and startup commitments.
• Escalate and resolve issues when training, qualification, staffing, procedures, or other manufacturing readiness deliverables threaten startup milestones or operational readiness commitments.
• Strengthen alignment between hiring plans, qualification plans, readiness milestones, engineering runs, and validation execution to ensure the manufacturing workforce is prepared to support ANC-2 startup and routine operations.
• Lead Manufacturing Fundamentals Training programs to support onboarding and qualification of new hires within the ANC-1 and ANC-2 organizations, ensuring consistent foundational knowledge and accelerated readiness.
• Serve as the training lead for the 2027 Learning Management System (LMS) migration, partnering with cross-functional stakeholders to support planning, implementation, change management, training impact assessments, and successful adoption of the new platform.
• Lead training improvement initiatives across manufacturing operations.
• Own and implement training-related corrective and preventive actions (CAPAs), ensuringtimelyexecution, effectiveness monitoring, and sustained compliance.
• Assess training effectiveness andidentifyopportunities to strengthen workforce capability, procedural adherence, and operational performance.
• Develop and deliver technical training programs, including the Wake Tech Customized Training Program, to improve employee knowledge, capability, and performance.
• Coach manufacturing personnel and frontline leaders on GMP compliance, operational excellence practices, and manufacturing best practices.
• Partner with Manufacturing, Quality, Engineering, and Continuous Improvement teams toestablishand maintain training curricula that support process changes, operational excellence initiatives, and inspection readiness.

Manufacturing Floor Leadership

• Maintain a strong presence on the manufacturing floor to providetrainingsupport, coaching, andtechnicalassistanceto frontline teams and leaders.
• Serve as a subject matter expert for LMS and training-related processes in manufacturing.
• Partner with operations teams toidentifyand implementtrainingimprovements that enhance safety, quality, delivery, and productivity.
• Drive right-first-time execution throughHuman and Organizational Performance (HOP) toolsand collection of operator feedback.

Cross-Functional Leadership

• Partner effectively with Quality, Engineering, Validation, Supply Chain,HR,and Manufacturing teams to achieve siteobjectivesandmaintainintegrated readiness plans that connect staffing, training, qualification, procedure readiness, engineering runs, and validation activities.
• Influence stakeholders at multiple organizational levels to drive alignment, resolve issues, and implement sustainable solutions.
• Serve as a key Manufacturing representative within ANC-2 Operational Readiness governance and planning activities, ensuring manufacturing workforce readiness, qualification execution, and startup risks are visible, aligned, and actively managed.
• Provide data-driven recommendations, readiness metric insights, and risk-based mitigation optionsto support business decisions, issue resolution,and operationalreadiness governance.

Basic Qualifications

• Doctorate degree OR
• Masters degree in chemistry, biology,or engineering & 3 years of biotechnology operations experience or
• Bachelors degree and 5 years of biotechnology operations experience or
• Associates degree & 10 years of biotechnology operations experience or
• High school diploma / GED & 12 years of biotechnology operations experience

Preferred Qualifications

• Hands on experience facilitating problem solving in a biotechnology environment
• Experience with training development and facilitation
• Experience owning and editing standard operating procedures
• Familiarity with the deviation management systems and corrective/preventative actions
• Project management skills with ability to multi-task and function in a dynamic environment
• Excellent communication skills and sense of urgency
• Demonstrated ability to forge and maintain strong relationships
• Strong knowledge of Learning Management Systems (LMS)

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities areprovidedreasonable accommodation toparticipatein the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.