Senior Manager – Manufacturing Programs Process Owner Organization
Job Location:
Holly Springs, MS - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
HOW MIGHT YOU DEFY IMAGINATION
If you feel like youre part of something bigger its because 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 over 10 million patients worldwide. Its time for a career you can be proud of.
Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch 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 Manager Manufacturing Programs
Live
What you will do
We are seeking a Senior Manager ofManufacturing Programsto lead the Process Owner organization within Manufacturing Support at ANC. This leadership role is responsible for providing technical process stewardship manufacturing support process governance and manufacturing changecontrolsupport for Upstream Downstream and Services Drug Substance Unit Operations.
The Process Ownerteamserves as the technical process steward for manufacturing operations partnering closely with Manufacturing Operations and cross-functional support functions to ensure manufacturing processes are effectively governed implemented maintained and continuously improved throughout their lifecycle.
Process Owners serve as the primary technical liaisons between Manufacturing Operations and support organizations including Quality Engineering Process Development Commissioning & Qualification (C&Q) Supply Chain and Digital Manufacturing. Through floor presencehypercaresupport process ownership operational readiness activities and manufacturing change implementation the team enables reliable compliant and efficient manufacturing execution.
The Senior Manager will lead a growing organization of Process Owners responsible for process ownership floor support andhypercareactivities operational readiness assessments dry and water run execution electronic batch record implementation support manufacturing change implementation BOM support and procedural governance. This role will also be responsible for expanding organizational capabilities including establishing and leading a swing-shift Process Owner team to provide enhanced operational support and manufacturing coverage.
What You Will Do
Lead and develop the Process Owner organization responsible for providing technical process stewardship and manufacturing support for Upstream Downstream and Services Drug Substance Unit Operations.
Provide direct management coaching mentoring and career development for Process Owners.
Develop and implement a swing-shift Process Owner organization to provide expanded manufacturing support and floor coverage.
Foster a culture of safety quality compliance accountability collaboration operational excellence and continuous improvement.
Provide strategic leadership for process ownership operational readiness manufacturing change implementationmanufacturing procedures manufacturing CAPAsand technical process stewardship.
Coordinate with site scheduling to ensure Process Owners provide timely hyper-care support and technical assistance during manufacturing campaigns startup activities process changes first-time executions and routine operations.
Serve as the primary interface between Manufacturing Operations and support organizations including Quality Engineering Process Development C&Q Supply Chain and Digital Manufacturing.
Oversee execution of dry runs water runs engineering runs and operational readiness activitiessupporting manufacturing.
Own manufacturing-relatedCAPAs andchange controls associated with process procedural and operational improvements.
Provide leadership andinputfor electronic batch record (EBR) and manufacturing execution system (MES) implementation activities impacting manufacturing operations.
Partner withTechnologyteams to ensure manufacturing processes are effectively translated into digital workflows and manufacturing execution platforms.
Partner with Supply Chain organizations to ensure manufacturing processes material strategies and Bill of Materials(BOM) support efficient manufacturing execution.
Provide process ownership oversight for BOM creation maintenance and updates associated with manufacturing process changes.
Ensure creation revision maintenance and periodic review of GMP documentation supporting manufacturing operations.
Drive strategic initiatives to improve process reliability manufacturing efficiency operator experience and operational performance.
Support inspection readiness activities and represent the Process Owner organization during audits and regulatory inspections as required.
Win
What We ExpectofYou
Basic Qualifications:
Doctorate degree and 2 years of biotechnology or pharmaceutical industry experience
OR
Masters degree and 6 years of biotechnology or pharmaceutical industry experience
OR
Bachelors degree and 8 years of biotechnology or pharmaceutical industry experience
OR
Associates degree and 10 years of biotechnology or pharmaceutical industry experience
OR
High school diploma / GED and 12 years of biotechnology or pharmaceutical industry experience
In addition to meeting at least one of the above requirements you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:
8 years related work experience in biotechnology or pharmaceutical manufacturing with progressively increasing responsibility.
Prior people leadership experience managing and developing technical teams.
Strong understanding of GMP manufacturing operations supporting Upstream Downstream and Services Drug Substance Unit Operations.
Experience with process ownership manufacturing support and technical process stewardship.
Experience supporting digital manufacturing systems electronic batch records (EBRs) manufacturing execution systems (MES) and associated process implementation activities within a GMP manufacturing environment.
Experience authoring approving and governing manufacturing SOPs and GMP documentationwithinQuality Systems (i.e. VeevaDocumentum etc.).
Experience leading manufacturingCAPAs/change controls and implementation activities.
Experience supporting operational readiness activities including dry runs water runs process implementation and startup support.
Experience partnering with Supply Chain organizations to support BOM management material readiness and manufacturing execution.
Excellent organizational written verbal communication and cross-functional leadership skills.
Salary Range
154173.00USD -208587.00USDRequired Experience:
Senior Manager
About Company
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the ... View more
