Global External Operations Specialist (GEO)
PSC Biotech Corporation, Pomona, CA, United States
Global External Operations Specialist (GEO)
Industry Pharma/Biotech/Clinical Research Work Experience 5+ years City Cork State/Province Cork Country Ireland Job Description
About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.
Overview:
We target diseases that lack effective therapies andaffect relatively small numbers of patients, many of whom are children. Theseconditions are often inherited, difficult to diagnose, progressivelydebilitating and have few, if any, treatment options, will continue to focus on advancing therapiesthat are the first or best of their kind
Technical Operations group is responsible for creatingour drugs for use in clinical trials and for scaling production of those drugsfor the commercial market. These individuals build and maintain cutting-edgemanufacturing processes and sites, provide quality assurance and qualitycontrol to ensure we meet regulatory standards, and procure the needed goodsand services to support manufacturing and coordinating the worldwide movementof our drugs to patients.
The Global External Operations (GEO) ‘virtual’ site worksdirectly with contract manufacturing organisations (CMO’s) globally to produce products.The GEO site is experiencing significant growth in 2026. The GEO OperationsSpecialist role will serve as an integral member of the GEO Operationsteam.This role will specificallysupport biologics and small molecule drug product processing as well asfinished goods packaging.Clinical andcommercial products are within the scope of the role.
The candidate will directly support the GEO OperationsManagers/Process Team Leads who are responsible for ensuring seamless supply ofproduct(s) from the contract manufacturing organizations (CMO).The candidate may also need to workindependently on specific activities, e.g. operational readiness execution fornew product/processes. The GEO Operations Specialist role will report to theDirector of Operations, GEO.
Requirements
Responsibilities:
Execute operational readiness requirements to enableCMO’s to produce products.
Provide direct support to Process Team Leads acrossCommercial & Clinical products (Small Molecules, Biologicals, Drug Productand Packaging operations on targeted/prioritized activities).
Manage and execute all transactional ERP aspects at productionefforts at CMOs (includes executing production transactions, updating workorder dates, receipting of purchase orders, inter organizational transfersetc.)Own and manage prioritized change controls and deviations within the QualityManagement System (QMS) to effective on time closure and no impact on supply.
Consolidation and issuance of key performance metrics perProcess Team.
Provide back-up support for Process Team Leads wherenecessary (e.g. holidays)
Support selected continuous improvement activitiesaligned to the site business plan objectives with clear and measurable time andmoney savings.
Work cross-functionally to perform rigorous root causeanalysis, to understand issues and implement corrective actions as appropriate.
Document key business processes in a standard format(e.g., Best Practice Document or Standard Operating Procedure).
There may be a need for this person to executeoperational tasks with a view to eliminating or reducing the number oftouchpoints associated with a task.
This list of support responsibilities may changedepending on business needs and employees are expected to be adaptable andflexible where this need arises.
Experience and skills:
Minimum requirement of 7 years’ experience within anOperations and regulated environment.
Required skills needed to accomplish theresponsibilities/essential functions include:
Will have a good working understanding of theprocesses/unit operations for biological drug product and/or finished goodspackaging.
Ability to project manage multiple activities/complexproject(s).
Technological savviness (e.g. power BI)
Will have a working understanding of ERP systems (e.g.SAP)
Ability to engage cross functional teams in theresolution of short-term issues and sustained performance for long-term goals.
Experience in lean/six sigma/continuous improvement toolsand techniques.
Excellent written and verbal communication skills.
A high level of initiative and drive, as well asexcellent organizational skills, are key role requirements.
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Industry Pharma/Biotech/Clinical Research Work Experience 5+ years City Cork State/Province Cork Country Ireland Job Description
About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.
Overview:
We target diseases that lack effective therapies andaffect relatively small numbers of patients, many of whom are children. Theseconditions are often inherited, difficult to diagnose, progressivelydebilitating and have few, if any, treatment options, will continue to focus on advancing therapiesthat are the first or best of their kind
Technical Operations group is responsible for creatingour drugs for use in clinical trials and for scaling production of those drugsfor the commercial market. These individuals build and maintain cutting-edgemanufacturing processes and sites, provide quality assurance and qualitycontrol to ensure we meet regulatory standards, and procure the needed goodsand services to support manufacturing and coordinating the worldwide movementof our drugs to patients.
The Global External Operations (GEO) ‘virtual’ site worksdirectly with contract manufacturing organisations (CMO’s) globally to produce products.The GEO site is experiencing significant growth in 2026. The GEO OperationsSpecialist role will serve as an integral member of the GEO Operationsteam.This role will specificallysupport biologics and small molecule drug product processing as well asfinished goods packaging.Clinical andcommercial products are within the scope of the role.
The candidate will directly support the GEO OperationsManagers/Process Team Leads who are responsible for ensuring seamless supply ofproduct(s) from the contract manufacturing organizations (CMO).The candidate may also need to workindependently on specific activities, e.g. operational readiness execution fornew product/processes. The GEO Operations Specialist role will report to theDirector of Operations, GEO.
Requirements
Responsibilities:
Execute operational readiness requirements to enableCMO’s to produce products.
Provide direct support to Process Team Leads acrossCommercial & Clinical products (Small Molecules, Biologicals, Drug Productand Packaging operations on targeted/prioritized activities).
Manage and execute all transactional ERP aspects at productionefforts at CMOs (includes executing production transactions, updating workorder dates, receipting of purchase orders, inter organizational transfersetc.)Own and manage prioritized change controls and deviations within the QualityManagement System (QMS) to effective on time closure and no impact on supply.
Consolidation and issuance of key performance metrics perProcess Team.
Provide back-up support for Process Team Leads wherenecessary (e.g. holidays)
Support selected continuous improvement activitiesaligned to the site business plan objectives with clear and measurable time andmoney savings.
Work cross-functionally to perform rigorous root causeanalysis, to understand issues and implement corrective actions as appropriate.
Document key business processes in a standard format(e.g., Best Practice Document or Standard Operating Procedure).
There may be a need for this person to executeoperational tasks with a view to eliminating or reducing the number oftouchpoints associated with a task.
This list of support responsibilities may changedepending on business needs and employees are expected to be adaptable andflexible where this need arises.
Experience and skills:
Minimum requirement of 7 years’ experience within anOperations and regulated environment.
Required skills needed to accomplish theresponsibilities/essential functions include:
Will have a good working understanding of theprocesses/unit operations for biological drug product and/or finished goodspackaging.
Ability to project manage multiple activities/complexproject(s).
Technological savviness (e.g. power BI)
Will have a working understanding of ERP systems (e.g.SAP)
Ability to engage cross functional teams in theresolution of short-term issues and sustained performance for long-term goals.
Experience in lean/six sigma/continuous improvement toolsand techniques.
Excellent written and verbal communication skills.
A high level of initiative and drive, as well asexcellent organizational skills, are key role requirements.
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