Global External Operations Specialist (GEO)

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded
in 1996, headquartered in Pomona, California, USA, with Global operations in
Ireland, India, Singapore, Australia and the US, serving 350 clients in more
than 23 countries worldwide. We provide cloud -based software solutions for
Quality Management and Regulatory Inspections, pharmaceuticals contract
manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model
by aligning our EVP as one of the unique selling point which includes the
opportunity to work with the most talented cohort of like -minded professionals
operating in the Pharma/ Biotech Industry. We offer a permanent contract of
employment giving exposure of working in Top Pharmaceutical client sites in a
diverse -cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide
unparalleled empowering career development though Learning & Development
in -house training mentorship through constant guidance to facilitate career
progression. We believe in creating high performing teams that can exceed our
client’s expectations with regards to quality of all scalable and business unit
deliverables, staying under budget and ensuring timelines for our deliverables
are being met.

Overview:

We target diseases that lack effective therapies and
affect relatively small numbers of patients, many of whom are children. These
conditions are often inherited, difficult to diagnose, progressively
debilitating and have few, if any, treatment options,  will continue to focus on advancing therapies
that are the first or best of their kind

Technical Operations group is responsible for creating
our drugs for use in clinical trials and for scaling production of those drugs
for the commercial market. These individuals build and maintain cutting -edge
manufacturing processes and sites, provide quality assurance and quality
control to ensure we meet regulatory standards, and procure the needed goods
and services to support manufacturing and coordinating the worldwide movement
of our drugs to patients.

The Global External Operations (GEO) ‘virtual’ site works
directly with contract manufacturing organisations (CMO’s) globally to produce products.
The GEO site is experiencing significant growth in 2026. The GEO Operations
Specialist role will serve as an integral member of the GEO Operations
team.  This role will specifically
support biologics and small molecule drug product processing as well as
finished goods packaging.  Clinical and
commercial products are within the scope of the role.

The candidate will directly support the GEO Operations
Managers/Process Team Leads who are responsible for ensuring seamless supply of
product(s) from the contract manufacturing organizations (CMO).  The candidate may also need to work
independently on specific activities, e.g. operational readiness execution for
new product/processes. The GEO Operations Specialist role will report to the
Director of Operations, GEO.

Requirements

Responsibilities:

• Execute operational readiness requirements to enable
  CMO’s to produce products.
  
• Provide direct support to Process Team Leads across
  Commercial & Clinical products (Small Molecules, Biologicals, Drug Product
  and Packaging operations on targeted/prioritized activities).
  
• Manage and execute all transactional ERP aspects at production
  efforts at CMOs (includes executing production transactions, updating work
  order dates, receipting of purchase orders, inter organizational transfers
  etc.)Own and manage prioritized change controls and deviations within the Quality
  Management System (QMS) to effective on time closure and no impact on supply.
  
• Consolidation and issuance of key performance metrics per
  Process Team.
  
• Provide back -up support for Process Team Leads where
  necessary (e.g. holidays)
  
• Support selected continuous improvement activities
  aligned to the site business plan objectives with clear and measurable time and
  money savings.
  
• Work cross -functionally to perform rigorous root cause
  analysis, 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 execute
  operational tasks with a view to eliminating or reducing the number of
  touchpoints associated with a task.
  
• This list of support responsibilities may change
  depending on business needs and employees are expected to be adaptable and
  flexible where this need arises.
  

Experience and skills:

• Minimum requirement of 7 years’ experience within an
  Operations and regulated environment.
  
• Relevant 3rd level qualification.
  

Required skills needed to accomplish the
responsibilities/essential functions include:

• Will have a good working understanding of the
  processes/unit operations for biological drug product and/or finished goods
  packaging.
  
• Ability to project manage multiple activities/complex
  project(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 the
  resolution of short -term issues and sustained performance for long -term goals.
  
• Experience in lean/six sigma/continuous improvement tools
  and techniques.
  
• Excellent written and verbal communication skills.
  
• A high level of initiative and drive, as well as
  excellent organizational skills, are key role requirements.
  
• Ability to work independently.