Process Scientist

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.

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 scale
  down model
  
• Write reports to a high standard and present data within
  the group
  
• Person will be flexible to support for 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 process
  to ensure the efficient and consistent production of vaccines.
  
• The ideal candidate will possess a deep understanding 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 DS
  Technical team to provide comprehensive technical leadership to DS
  manufacturing. 
  
• Support equipment qualification deliverables during
  execution of project phase including equipment Commissioning &
  Qualification, IOQ.
  
• 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 downstream process development
  
• 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
  

• This is a 11 Month Maternity Cover role