Bioprocess Associate
Bioprocess Associate
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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 cloudbased 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 likeminded 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 diversecultural work setting.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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 multiproduct mode which requires flexibility to adjust as the pipeline of clinical and commercial biologicsbased 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 endto 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 multidisciplined 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 crossfunctional 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
Level 6 qualification in a science or engineering discipline desired. 2+ years experience in a GMP Manufacturing requirement shall be deemed equivalent Understanding of Upstream and Downstream Unit Operations for mAb manufacturing
Education
Level 6 qualification in a science or engineering discipline desired. 2+ years experience in a GMP Manufacturing requirement shall be deemed equivalent Understanding of Upstream and Downstream Unit Operations for mAb manufacturing
Employment Type
Full Time
