Senior Manufacturing Bioprocess Associate
Senior Manufacturing Bioprocess Associate
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
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:
The client facility is a premier stateoftheart facility that enables and advances our best work. By integrating leadingedge technology with a dynamic activitybased workspace the facility will support seamless connection and collaboration within and across teams and functions. Client site will provide Biologics Drug Substance manufacturing for Clinical Supply Registration & Commercial Launch. The client 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 Senior Manufacturing Bioprocess Associate to provide operational support for manufacturing operations of the Late Stage and Launch Pipeline products at our new state of the art single use biotechnology facility.The Senior Manufacturing Bioprocess Associate will support endto end production operations for both Fed Batch and Continuous Manufacturing.
Requirements
Primary activities/responsibilities:
- Operate equipment according to electronic batch records sampling plans and standard operating procedures.
- Work as part of a dedicated process team where flexibility and teamwork are a key requirement.
- Ability to solve problems with a desire to continuously learn improve and develop.
- 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.
Education and Skills Required:
- Level 7 qualification in a science or engineering discipline desired.
- A level 6 with a minimum of 3 years experience in a GMP Manufacturing requirement shall be deemed equivalent
- Competent in troubleshooting and show practical problemsolving capabilities.
- 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.
- Proficiency in various SingleUse technologies in a manufacturing environment
Preferred Experience and Skills:
- Commissioning and Qualification experience
- Understanding of Upstream and Downstream Unit Operations for mAb manufacturing
- Understanding of both continuous and batch fed manufacturing processes
Reports to:Drug Substance Process Operations Manager
Level 7 qualification in a science or engineering discipline desired. A level 6 with a minimum of 3+ years experience in a GMP Manufacturing requirement shall be deemed equivalent Competent in troubleshooting and show practical problem-solving capabilities. 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.
Education
Level 7 qualification in a science or engineering discipline desired. A level 6 with a minimum of 3+ years experience in a GMP Manufacturing requirement shall be deemed equivalent Competent in troubleshooting and show practical problem-solving capabilities. 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.
Employment Type
Full Time
