Manufacturing Operations Specialist

About PSC BiotechWho 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.