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Bioprocess Associate

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Job Description - Bioprocess Associate

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:


  • The BTA is responsible for all procedures and processes
    associated with the manufacture of Drug Substance at  manufacturing facility, at the highest
    standards of Safety, Quality and Compliance.
  • The BTA will be responsible for undertaking manufacturing
    operations involved in the production of biologic drug substance on their
    designated shift.
  • Key responsibilities include the execution of an automated
    recipe using paperless technology to progress the drug substance through
    inoculation and cell culturing activities, leading to filtration and
    purification of the product in a state -of -the -art single use technology -based
    facility. The incumbent will be involved in setting up the single use
  • equipment between runs, carrying out the production
    process according to world class GMP and EHS principles. The BTA will also be
    involved in driving to optimise and improve the processing activities through
    use of standard work and lean processing techniques while supporting operations
    team to consistently deliver on specific Key Performance Indicators (KPIs). At
    all times, this role is focused on delivery to the patient through living the culture
    including a commitment to safety, focusing on right first time in everything we
    do and a concentrating on the engagement and development of self and peers.
  • The Manufacturing Biotech Associate will work in a
    manufacturing self -directed shift team to deliver batch operations
    successfully, identify and resolve issues in order to allow the site to deliver
    for our patients in a culture that supports Quality, EHS, Learning and Continuous
    improvement.

Shift Pattern: 24/7



Requirements

Responsibilities:

  • The production of biologic drug substance on their
    designated shift team and will be responsible for the preparation, operation
    and monitoring of equipment, use of business systems and carrying out tasks
    including but not limited to the cleaning, validation, in -process testing.
  • The progression of an automated recipe using paperless
    technology in order to generate the drug substance through inoculation and cell
    culturing activities directing to filtration and purification of the product.
  • Setting up the single use equipment between runs,
    carrying out the production process according to world class GMP and EHS standards
    and driving to optimise and improve the processing activities through use of
    standard work and lean processing techniques.
  • Focusing on delivery to the patient through living the culture
    including a commitment to safety, focusing on right first time in everything we
    do and concentrating on the engagement and development of self and peers.

 

Skills Required:

  • A science qualification in a technical, engineering or
    science -based discipline or equivalent.
  • 0 to 3 years’ experience in the biotechnology and/or
    pharmaceutical industry or equivalent.
  • Experience in a highly regulated pharmaceutical
    manufacturing environment
  • Good understanding in the production of biologic drug
    substance and experience an advantage.
  • Ability to work as part of a shift team and on own
    initiative in a constructive manner.
  • Ability to think logically and be proactive under
    pressure.
  • Flexible and self -motivated


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