Front Line Manufacturing Manager Bulk Drug Substance Services Days

HOW MIGHTYOUDEFY IMAGINATION

Youveworked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skillsexperienceand passion to work toward your goals At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies reaching over10 million patientsworldwide. Come do your best work alongside other innovative driven professionals in this meaningful role.

Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the AmgenFleXBatch facility will combine the latest in disposable 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.

Front Line Manufacturing Manager - Bulk Drug Substance Services - Days

What youwill do

Letsdo this.Letschange the world.Amgen is seeking aManagerManufacturingServicesto provide frontline leadership supporting the facility expansion program and facility startup. Thisessentialrole will lead a team responsible for manufacturingoperationsincludingRaw Material and Solution Logistics Weighing and Dispensing Buffer/Media Solution Preparation Parts Washer and Autoclave and material handlingwhile partnering across functions to ensure successful operational readiness technology transfer and rampup of manufacturing operations within the new facility.

The Manager will play a critical role supporting the designbuild startup and operational phases of the facility expansion. The position will initially focus on facility startup and operational readiness activities transitioning to manufacturing leadership as the facility becomes operational.During this phase of thestartup you will be expected toworkaMonday Friday schedule from 8am 5pm.

This role may require work outside standard business hours including nonstandard shifts as needed to support startup commissioning and qualification (C&Q) and engineering execution.As the business moves from C&Q to manufacturing operations this essential positionwillwork ona 12-hour 2-2-3 schedule from 5:45 am to6:15pmsupporting our critical 24/7 manufacturing operations.As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs the Manager must be able to work assigned 12-hourshift including during inclement weather some holidays and requested overtime in support of our operations.

Responsibilities

• Frontline Leadership:Lead develop and coach a manufacturing team; set clear performance expectations; foster a strong culture of safety quality and accountability.

• Facility Startup & Operational Readiness:Support design build commissioning qualification (C&Q) staffing training and readiness milestones for a new manufacturing facility.

• Manufacturing Operations: Ensure safe cGMPcompliant execution; drive performance across safety quality schedule and cost; resolve deviations and operational issues.

• Technology Transfer & Process Implementation:Support transfer and implementation of manufacturing processes; ensure manufacturability troubleshooting and continuous improvement.

• CrossFunctional Collaboration:Partner with Quality Engineering NPI Supply Chain Validation and Site Leadership to enable successful startup and rampup.

• Compliance & Inspection Readiness:Maintaininspection readiness and adherence to regulatory and Amgen quality standards.

• Continuous Improvement:Identifyand drive efficiency reliability and scalability improvements as operations mature.

• Shift Support:Work nonstandard hours as transitioning to a 12hour 223 dayshift supporting 24/7 operations.

Preferred Qualifications

• Bachelors degree in Life Sciences or Engineering

• Experience with facility startup commissioning or operational readiness

• Biologics / drug substance manufacturing experience (Services)

• cGMP manufacturing experience (5 years preferred)

• Experience with technology transfer and process implementation

• Prior Area Lead / Specialist / Manager experience

• Strong leadership performance management and conflictresolution skills

• Solid understanding of regulatory requirements

• Proficiencywith MES/EBRDeltaV Maximo Veeva LIMS and electronic quality systems