Lead Associate Manufacturing – Manufacturing Investigations 

HOW MIGHT YOU DEFY IMAGINATION?

If you feel likeyou’repart of something bigger,it’sbecause you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, anddeliveringever-better products that reach over10 million patientsworldwide.It’stime for a career you can be proud of. 

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

Lead Associate Manufacturing –Manufacturing Investigations

Live

What youwill do

Let’sdo this.Let’schange the world. In this vital role, you will be a key member of the team that investigatesmajordeviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams andstakeholder groupsincluding,Process Development,Facilities &Engineering,Automation, EHSS, andQuality. This positionis responsible forensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.

Responsibilities include:

• Managesimpledeviationand environmental monitoringinvestigations,specifically within theControlledEnvironmental 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,identifytrends, and assess potential impactstoproduct quality, manufacturing operations, and contamination control programs.

• Present investigations to regulatory inspectors, internal auditors, and management.

• Clearly communicate investigation progress toimpactedareas 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

• UseOperationalLearningTeam strategies topromote open collaboration with stafftomaximizeinvestigation findings. 

• Developtracking tools to ensure on-time closure and proactivereviewof deviation investigations. 

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Win

What we expectofyou

We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator weseekhas a biologics Drug Substancemanufacturingandmicrobiologicalinvestigationsbackground with strong cross-functional project management and communication skills as well as the below qualifications. 

Basic Qualifications:

Bachelor’s degreeor &6months ofdirectly relatedexperience

Or

Associate’sdegree &2years ofdirectly relatedexperience

Or

High school diploma / GED &4years ofdirectly relatedexperience

Preferred Qualifications:

• 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 complexroot cause analysistools (5-whys, fishboneetc.)critical thinking, project management, and quality systems.

• Degree in Science or Engineering(Microbiology or similar a plus)

• Experience leading investigations

• Experience usingVeevaQMSfor 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

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Thrive

What you can expectofus 

In addition to the base salary, Amgen offers a Total Rewards Plancomprisinghealth 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 including: 

• 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

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