Senior Associate Manufacturing - Manufacturing Investigations

Senior Associate Manufacturing – Manufacturing Investigations What you will do

In this vital role, you will be a key member of the team that investigates major deviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams and stakeholder groups including Process Development, Facilities & Engineering, Automation, EHS, and Quality. This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.

• Manage simple deviation and environmental monitoring investigations, specifically within the Controlled Environmental Monitoring space, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
• Apply a basic understanding of microbiology principles, environmental monitoring programs, and contamination control strategies to support environmental monitoring investigations.
• Interpret environmental monitoring data, identify trends, and assess potential impacts to product quality, manufacturing operations, and contamination control programs.
• Present investigations to regulatory inspectors, internal auditors, and management.
• Clearly communicate investigation progress to impacted areas and leadership.
• Coordinate and effectively lead cross‑functional teams through investigations, and complete milestones on‑schedule.
• Present investigation findings and technical information to diverse audiences and communicate moderately complex issues in a clear and concise manner.
• Build effective relationships across functions.
• Navigate through ambiguity and provide a structured problem‑solving approach.
• Apply inductive and deductive reasoning in the investigation process.
• Clear and concise technical writing.
• Use Operational Learning Team strategies to promote open collaboration with staff to maximize investigation findings.

We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator we seek has a biologics Drug Substance manufacturing and microbiological investigation background with strong cross‑functional project management and communication skills as well as the following qualifications.

• High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience
• Associate’s Degree + 2 years manufacturing and/or other regulated environment experience
• Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience
• Master’s Degree

• 3+ years related work experience (manufacturing, microbiology, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
• Basic understanding of Drug Substance manufacturing, environmental monitoring programs, and contamination control principles.
• Experience with compliance, problem‑solving, simple and complex root cause analysis tools (5‑whys, fishbone, etc.) critical thinking, project management, and quality systems.
• Degree in Science or Engineering (Microbiology or similar a plus)
• Experience leading investigations
• Experience using Veeva QMS for Deviation investigations and CAPAs
• Demonstrated project management ability
• Excellent written and verbal communication skills
• Ability to work in a team matrix environment and build relationships with partners
• Strong interpersonal skills

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities.

• Comprehensive employee benefits package, including a retirement and savings plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan.
• Stock‑based long‑term incentives.
• Award‑winning time‑off plans and bi‑annual company‑wide shutdowns.
• Flexible work models, including remote work arrangements, where possible.

Amgen is an Equal Opportunity employer and will consider you without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in 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.