Process Scientist

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Dundalk
• State/Province Louth
• Country Ireland

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 points 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 to 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 through 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.

Role Description:

• An amazing opportunity has arisen for a Process Scientist. You will play an important role within our vaccine manufacturing MSAT lab, primarily providing process support to upstream and downstream lab scale experiment planning and execution.
• Lead and support upstream and downstream related studies at small scale in MSAT lab.
• Strong background in setting up cell culture seed train, bioreactors setup and running process smoothly.
• Strong background in TFF, clarification, filtration and dilution of drug substance.
• Strong understanding of upstream and/or downstream process development.
• Strong understanding of upstream and/or downstream scaledown model.
• Write reports to a high standard and present data within the group.
• Person will be flexible to support some of the weekend work.
• Working flexibility to support weekend work if required.
• Support manufacturing to perform any study required during engineering, validation or clinical batches.
• This role will support satellite runs of vaccine processes to ensure the efficient and consistent production of vaccines.
• The ideal candidate will possess a deep understanding of the drug substance process as well as a passion for problem solving and process improvements in a GLP environment.
• Ensure a high standard of record keeping and documentation of experiments and investigations.
• Support in drafting SOP, protocols, MBRs and other technical documents and revision of documents including technical memo.
• Have in depth knowledge of vaccine drug substance process and understand the basis of specification and critical attributes.
• This role will partner with the MSAT team and DSTechnical team to provide comprehensive technical leadership to DS manufacturing.
• Identify and implement projects to continuously improve the compliance and manufacturing capabilities within the DS MSAT lab area.

Requirements

Experience, Knowledge & Skills:

• Experience in cell culture process development and bioreactor operation.
• Experience in bioprocess development, biopharmaceutical production, and/or biological process validation experience with successful tracking record.
• Biological production process validation experience will be an advantage.
• Have knowledge and understanding of biopharmaceutical CGMP quality systems and operation will be an advantage.
• Have excellent oral presentation skill for internal and external meeting.
• Detail oriented organizational skill to track and maintain project activities.
• Experience in troubleshooting and investigating critical deviation, performing risk analysis on production process, coordinating technical transfer, and executing process validation.

Qualifications & Education:

• Masters or Bachelor's degree in Biology, Biotechnology, Microbiology, Chemistry or Pharmaceutical Engineering or related Science or Engineering major or equivalent experience.
• Minimum 2-3 years working in a biological, or vaccine clinical or commercial manufacturing.