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 PropositionEmployees 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:By integrating leading-edge technology with a dynamic,
activity-based workspace, the facility will support seamless connection and
collaboration within and across teams and functions. Facility 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 Late Stage and Launch Pipeline products at our new state of
the art single use biotechnology facility in Ireland. This role will involve supporting manufacturing
operations on a Shift Rotation basis.Facility serves as a magnetic force that attracts,
recognizes, and integrates people of diverse backgrounds and perspectives.Reports to: Drug Substance Process Operations Manager RequirementsRole Functions:The Senior Manufacturing Bioprocess Associate will
support end-to end production operations for both Fed Batch and Continuous
Manufacturing.Support on floor manufacturing of pipeline productsOperate equipment according to electronic batch records, sampling plans and standard
operating procedures.Shift role 24/7 (Onsite)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. Conduct all work activities with a strict adherence to
the safety and compliance culture on siteSupport the Authoring of electronic batch records,
sampling plans, work instructions and standard operating procedures. Skills and 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 equivalentCompetent 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
requirementsFamiliarity 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:Commissioning and Qualification experience Understanding of Upstream and Downstream Unit Operations
for mAb manufacturingUnderstanding of both continuous and batch fed
manufacturing processes #LI-KV1