Job DescriptionAbout 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: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 Dunboyne, Ireland.
The client serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives.
Employees will feel not only that they belong in the Dunboyne, but that the facility belongs to and is shaped by them. This role will involve supporting manufacturing operations on a Shift Rotation basis.Reports to: Drug Substance Process Operations ManagerRequirementsResponsibilities:The Lead Manufacturing Bioprocess Associate will support end-to end production operations for both Fed Batch and Continuous Manufacturing.Lead/Guide team members to support on floor manufacturing of pipeline products on a shift rotationProvide guidance, coaching and mentoring to the rest of the production teamOperate 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 and take new perspectives on existing solutions 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.Lead, facilitate and participate daily in cross-functional teams to collaborative effectively to ensure compliance Education:Bachelor's degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering. Experience & Skills:5 years + Biotech Industry (bulk manufacturing of pharmaceutical or biological components)Competent in troubleshooting and show practical problem-solving capabilities.Ability to work independently and within a cross-functional team.Understanding of multi column chromatography conceptsFamiliarity 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 environmentProblem, Deviation, and Change Management experience Preferred Experience and Skills: Commissioning and Qualification experience Experience of Upstream and Downstream Unit Operations for mAb manufacturing with in depth knowledge of key unit operations.Understanding of both continuous and batch fed manufacturing processes Experience leading, presenting, or supporting Regulatory Inspections and Site Internal Audits Requirements5 years + Biotech Industry (bulk manufacturing of pharmaceutical or biological components) Competent in troubleshooting and show practical problem-solving capabilities.
Ability to work independently and within a cross-functional team.
Understanding of multi column chromatography concepts 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 Problem, Deviation, and Change Management experience