Research Associate Upstream Process Development

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.

Perform & document scientific experiments in
collaboration with cross-functional stakeholders as part of the BCoE or Site
strategy, and/or in support commercial & clinical product portfolio. 12 Month of Contract with possibility of an extension.

Responsibilities:

Laboratory /Project work:

• Under close supervision of scientists, project and
  functional leads executes defined procedures to support BCoE studies and
  investigation activities with lab scale upstream processes in the multi-product
  lab.
  
• Learns core scientific techniques quickly and
  demonstrates understanding of core scientific principles and protocols
  (including batch, fed-batch and perfusion processes).
  
• Identifies routine experimental issues and follows SOPs
  and BPDs to resolve them.
  
• Produces accurate, reproducible data entries and
  maintains laboratory quality through adherence to safety and SOPs.
  
• Perform daily mammalian cell culture expansion and
  bioreactor monitoring, including bioreactor sampling and in-process analysis
  utilizing standard bioprocess analytical equipment.
  
• Understanding of microbial cell expansion and
  fermentation process execution is desirable.
  
• Understanding of downstream purification process is
  desirable.
  
  

Requirements

General:

• Execute and complete projects with supervision.
  
• Generate, review and share raw data with peers and
  project leads.
  
• Maintain up-to-date documentation of laboratory work
  carried out including documentation storage and archiving in accordance with
  GLP.
  
• Support maintenance of lab instructions, BPDs, SOPs,
  templates.
  
• Support maintenance and calibration of lab equipment with
  accompanying documentation.
  
• Contribute to the evaluation of new equipment.
  
• Be a team player with excellent communication skills.
  
• Play an active role in maintaining and enhancing the
  safety of the workplace and the laboratories.
  
• Comply with applicable GxP regulations, SOPs, HSE, &
  other guidelines in the laboratory as applicable.
  
• May be required to work periodically out of normal
  business hours.
  

Scope:

• Quantify the scope or impact of the job in terms of
  revenue, expenses, capital investment, headcount, etc
  

Key Performance Metrics:

• Adherence to project plans & deliverables
  
• Adherence to applicable GxP and EHS requirements
  
• Technical reports executed on time and on quality
  
• Efficient technical exchange with Project leads
  

Education:

• State both the minimum and the preferred educational
  attainment (or equivalent experience), and describe essential and desired
  subject matter, certifications, special training, etc.
  
• Bachelor’s degree or higher in Science or Engineering
  

Experience:

• State both the minimum and the preferred number of years
  of relevant experience, and describe the essential functions of the job
  
• A minimum of 1 year experience in the pharmaceutical
  industry or equivalent strong laboratory experience.
  
• Working knowledge of pharmaceutical regulatory
  requirements appropriate to level and understanding of the cGMP manufacturing
  process for Biologics.