Senior Specialist – Complex Investigations

HOW MIGHT YOU DEFY IMAGINATION

If you feel likeyourepart of something biggeritsbecause 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 over10 million patientsworldwide.Itstime for a career you can be proud of.

Be part of Amgens 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 Amgens plan to be a carbon-neutral company by 2027.

Senior Specialist Complex Investigations

Live

What you will do

Letsdo this.Letschange the world.In this vital role you will serve as the site expert responsible for leading the most critical high-risk and complex investigations within the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will partner with Manufacturing Quality Process Development Engineering Automation Microbiology and site leadership to investigate significant quality events recurring deviations product-impacting events and systemic compliance issues.

This positionis responsible forensuring the sites most consequential investigations are conducted with scientific rigor thorough root cause determination effective corrective and preventive actions and clear communication to senior leadership. The role serves as the escalation point for investigations that present elevated product quality patient safety compliance or regulatory risk.

Responsibilities include:

• Lead the sites most complexand cross-functionaldeviation investigations.

• Servesasa technical resourcefor investigations involvingcomplexqualitymicrobiologymanufacturing orcomplianceissues.

• Assemblesand leadscross-functional investigation teams through advanced root cause analysis and risk assessment activities.

• Apply advanced investigation methodologies including Kepner-Tregoe Quality Risk Management 5-Why Fishbone Analysis and data-driven problem solving.

• Drivedevelopmentof robust CAPAs andevaluate the effectivenessof implemented actions.

• Identifysystemicopportunitiesand recurring trends across quality events and drive site-wide improvement initiatives.

• Provide expert technical guidance and coaching to investigators and functional SMEs.

• Present investigation status findings risks and recommendations to site leadership and governance teams.

• Support regulatory inspections and internal audits by presenting investigation strategiesoutcomes andassociated remediation activities.

• Partner with Quality Manufacturing Engineering Process Development and Microbiology organizations to ensuretimelyand compliantinvestigationclosure.

• Develop andmaintainmetrics that assessinvestigationquality effectiveness and timeliness.

• Drive continuous improvement of investigation processes tools and standards across the site.

• Author and review technically complex investigation reports risk assessments and executive summaries.

• Mentor investigators on investigation excellence technical writing and root cause analysis.

• Influence site-wide investigation practices through knowledge sharing process optimization and implementation of industry best practices.

Win

What we expect of you

The collaborative investigator weseekhas extensive experience leading complex investigations in a regulated biotechnology or pharmaceutical environment anddemonstratesexceptional technical analytical and leadership capabilities.

Basic Qualifications:

Doctorate degree &2year ofdirectly relatedexperience

Or

Masters degree &4years ofdirectly relatedexperience

Or

Bachelors degree &6years ofdirectly relatedexperience

Or

Associates degree & 10 years ofdirectly relatedexperience

Or

High school diploma / GED & 12 years ofdirectly relatedexperience

Preferred Qualifications:

• 7 years of biotechnology or pharmaceutical industry experience with progressively increasing responsibility.

• Extensive experience leading complex cross-functional investigations involving quality systems manufacturing processes microbiology contamination control or compliance-related issues.

• Demonstratedexpertisein advanced root cause analysis methodologies and quality risk management.

• Strong understanding of GMP regulations quality systems deviation management CAPA systems and regulatory expectations.

• Experience serving as a lead presenter or SME during regulatory inspections and internal audits.

• Experience using Veeva QMS for investigations and CAPA management.

• Demonstrated ability to influence cross-functional teams and senior leadership.

• Strong project management and organizational skills.

• Exceptional technical writing and verbal communication skills.

• Degree in Science or Engineering (Microbiology Biology Chemical Engineering Biochemistry or related discipline preferred).

• Ability to navigate ambiguity and provide structured data-driven decision making.

• Demonstrated ability to mentor investigators and influence investigation practices across multiple functional areas.

Thrive

What you can expect of us

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

for a career that defies imagination

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

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 are provided reasonable 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.

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