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Bioprocess Associate

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Job Description - Bioprocess Associate

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.

 

Overview:

Client will provide Biologics Drug Substance
manufacturing for Clinical Supply, Registration & Commercial Launch.  The facility is designed to be operated in a
multi -product mode which requires flexibility to adjust as the pipeline of
clinical and commercial biologics -based medicines demands change.

An amazing opportunity has arisen for a Manufacturing
Bioprocess Associate to provide operational support for manufacturing
operations of the client Late Stage and Launch Pipeline products at our new
state of the art single use biotechnology facility .    

The facility serves as a magnetic force that attracts,
recognizes, and integrates people of diverse backgrounds and perspectives.

 


Requirements

Role Functions:

  • The Manufacturing Bioprocess Associate will support
    end -to end production operations for both Fed Batch and Continuous
    Manufacturing.

Primary activities/responsibilities:

  • Operate equipment according to electronic batch records,sampling plans and standard
    operating procedures.

  • Work as part of a multi -disciplined, diverse and
    dedicated process team where flexibility and teamwork are an essential
    requirement 

  • Support weekend or out of hours work on select time
    frames to support manufacturing activities.

  • Conduct all work activities with a strict adherence to
    the safety and compliance culture on site

  • Support the Authoring of electronic batch records,
    sampling plans, work instructions and standard operating procedures.

 

Required Education, Experience and Skills:               

  • Level 6 qualification in a science or engineering
    discipline desired. 
  • 2+ years experience in a GMP Manufacturing requirement
    shall be deemed equivalent
  • Ability to work independently and within a
    cross -functional team.
  • Familiarity with contamination control and batch release
    requirements
  • Familiarity with Emerson DeltaV, Pas X, and the use of Automation in a
    manufacturing Process.  
  • Experience with various SingleUse technologies in a
    manufacturing environment

 

Preferred Experience and Skills:        

  • Understanding of Upstream and Downstream Unit Operations
    for mAb manufacturing

 

Reports to:Drug Substance Process Operations
Manager

#LI -PM3

 

 



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