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Bioprocess Associate

Bioprocess Associate

PSC Biotech LtdDunboyne, MH, ie
20 days ago
Job type
  • Quick Apply
Job description

Job Description

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
  • Requirements

    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.

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