Senior Associate ManufacturingManufacturing Investigations

BioSpace; Holly Springs (NC); Presencial; USD 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Comprehensive benefits package

Discretionary annual bonus program

Stock-based long-term incentives

Flexible work models including remote,

Descripción de la vacante

Amgen, in North Carolina, seeks a Senior Associate Manufacturing Investigations to join the team responsible for investigating major deviations at the Biologics Drug Substance Manufacturing plant. You will interface with GMP manufacturing teams and stakeholders, drive investigation quality, and lead cross-functional teams to closure.

The role emphasizes rigorous technical writing, regulatory communication, and structured problem solving, with a focus on environmental monitoring and contamination

Formación

• High School Diploma/GED plus 4 years in manufacturing or regulated environment.
• Associate's Degree plus 2 years manufacturing or regulated environment experience.
• Bachelor's Degree plus 6 months manufacturing or regulated environment experience.
• Master's Degree.
• 3+ years related work experience 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, and root cause analysis tools (5-why, fishbone, etc.).
• Demonstrated project management ability and strong communication skills.

Responsabilidades

• Manages simple deviation and environmental monitoring investigations within the Controlled Environmental Monitoring space, leading root cause analysis and CAPA development.
• Apply microbiology principles to support environmental monitoring investigations.
• Interpret environmental monitoring data, identify trends and assess potential impact on product quality and operations.
• Present investigations to regulatory inspectors, internal auditors, and management.
• Communicate investigation progress to impacted areas and leadership.
• Coordinate and lead cross-functional teams through investigations and milestones on schedule.
• Present findings clearly to diverse audiences and maintain strong cross-functional relationships.

Conocimientos

GMP manufacturing

Environmental monitoring

Root cause analysis

Cross-functional teamwork

Regulatory communication

Problem solving

Educación

High School Diploma/GED

Associate Degree

Bachelor's Degree

Master's Degree

Descripción del empleo

HOW MIGHT YOU DEFY IMAGINATION?If you feel likeyourepart of something bigger,itsbecause 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, anddeliveringever-better products that reach over10 million patientsworldwide.Itstime for a career you can be proud of.

Senior Associate Manufacturing Manufacturing Investigations

Live

What you will do

Letsdo this.Letschange 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.

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

• HighSchoolDiploma/GED + 4yearsmanufacturing and/orotherregulatedenvironmentexperience
• Or
• AssociatesDegree+ 2 yearsmanufacturing and/orotherregulated environment experience
• Or
• BachelorsDegree+ 6 monthsmanufacturing and/orotherregulatedenvironmentexperience
• Or
• Master'sDegree

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

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

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.

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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