Specialist Manufacturing: Manufacturing Execution System (MES)

Live

What you will do

Let’schange the world.In this vital role you will communicate and interface between the GMP manufacturing teams in theAmgen North Carolina (ANC) Biologics Drug Substance ManufacturingplantandProcessDevelopment scientific groups.As part of ANC27s Manufacturing Supportteam, this positionis responsibleforensuring all Electronic Batch Records accuratelydocumentthe manufacturing process.It is ahighly visible role across the site with the core responsibility ofdriving batch record optimization between the manufacturing floor and the global MES team.This role will also offer the opportunity to propose,participate, and lead team improvement initiatives to drive improved productivity onmanufacturingfloor.

• Manufacturing Execution System(MES)Specialist coordinating withGlobal MES Team,Manufacturing, Process Development,Process Owner, and Quality to create andmodifyelectronic batch records to support the implementation of new products and/or technologies into the plant.

• Subject Matter Expertwho leadsand/orparticipatesin projects, ensuring that electronic batch records accurately and effectively record all necessary process data for unit operationsin Koerber PAS|X.

• Support Manufacturing in troubleshooting, problemsolvingand RCAs. Support CAPA development to prevent error recurrence.

• Owns Generic Master Batch Record (GMBR) optimizationsand functions as theprimaryliaison between the site MES and global MESteam to drive on time deliveries of the GMBRs.Respondsto regulatory questions and/or audit findings.

• Champions Lean Transformation and OEinitiatives,facilitatesthe drive towards continuous improvement in the plant and tracks progress on a plant level.

• Support batch record Standardization to enable network wide usage of generic batch records.

Win

What we expectofyou

We are all different, yet we all use our unique contributions to serve patients. Themanufacturingprofessional weseekhas a biologicsDrug Substancemanufacturing background withstrongcross-functional project managementandcommunicationskillsas well asthebelowqualifications.

Basic Qualifications:

• Doctorate degree OR

• Master27s degree in chemistry, biology,or engineering & 3 years of biotechnology operations experience or

• Bachelor27s degree and 5 years of biotechnology operations experience or

• Associate27s degree & 10 years of biotechnology operations experience or

• High school diploma / GED & 12 years of biotechnology operations experience

Preferred Qualifications:

• Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry

• Excellentcross-functionalproject management, meeting facilitation, andtechnical writing skills

• Experience inGMPmanufacturingoperations

• Strong technical knowledge of drug substance processing (Inoculation,Bioreactors,Harvest,chromatography, filtration, bufferpreparation) and a broad understanding of related disciplinary areas in bioprocessing.

• Extensive experience with electronic batch record design in Koerber PAS|Xor comparable software for electronic batch records with some understanding of editing and validation

• Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms

• Ability to coach,mentorand/or cross train colleagues within core technical areas

Thrive

What you can expectofus

As we work to develop treatments that take care of others, we also work to care for our teammates27 professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is provided below.

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 forfield 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.

Apply now

for a career that defies imagination

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

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