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.