Clinical Research jobs in County Cork

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.

Summary:

The Analytical Sciences department . is seeking a skilled Analytical Biochemist and/or Biologist at the Research Associate level to join a team focused on supporting gene therapy & enzyme replacement therapy. The successful candidate will be a self-motivated, independent and critical thinker who has experience of working in a multi-disciplinary and fast paced environment, and solid communication skills. The candidate will execute a wide variety of analytical methods and assays for the characterization of therapeutic candidates in development with a particular focus on testing to support clinical and commercial process development teams.

Requirements

Responsibilities:

• Primary responsibility: Execute product testing to support Drug Substance and Drug Product process development teams
  
• Perform non-routine testing of in-process samples, and final product samples of key projects for the TDS processing team
  
• Conduct analytical tests using techniques such as HPLC, UPLC, CE, FTIR, and plate-based methods
  
• Document all test results accurately and in compliance with Good Laboratory Practices (GLP) and company SOPs.
  
• Collaborate with cross-functional teams including Drug Substance Technologies, Drug Product Device Technologies, Manufacturing, and Quality.
  
• Provide concise and quantitative analysis of data and interpretation of experimental results.
  
• Provide effective oral presentations at departmental meetings
  
• Report progress to the manager on a weekly basis on each program
  
• Write up experimental plans and results and share with collaborators and supervisor; present data proactively and regularly in group meetings.
  
• Catalogue data/reports electronically in an accessible manner for inspections

Required Skills:

• Strong understanding of GMP, GLP, and regulatory standards
  
• Familiar with protein chemistry/function and bioassays
  
• Experienced in cell culture techniques and protein expression/activity readout methods
  
• Excellent communication, collaboration and writing skills
  
• Proven data analysis, interpretation and scientific communication skills
  
• Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment

Desired Skills:

• Experience in method troubleshooting, qualification, and transfer
  
• Knowledge of biopharmaceutical development is a plus

Education:

• Research Associate 1: Bachelors degree in biological sciences and at least 2 years of relevant experience, or 1 year experience with Masters. Title will be commensurate with experience
  
• Research Associate 2: Bachelors degree in biological sciences and at least 3 years of relevant experience, or 2 year experience with Masters. Title will be commensurate with experience

Equipment:

• Operation of standard laboratory equipment for biochemistry and for cellular assays

Will report to the Sr. Manager Analytical Services.