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
* The Downstream Bioprocess Associate will play a key role in executing manufacturing operations for the production of biologic drug substances during assigned shifts. This position involves running automated recipes using paperless technology to guide the process from inoculation and cell culture through to filtration and purification, within a state-of-the-art facility utilizing single-use technologies.
* The incumbent will be responsible for setting up and operating single-use equipment between production runs, ensuring all processes are executed in compliance with world-class GMP (Good Manufacturing Practices) and EHS (Environment, Health & Safety) standards.
* In addition to core operational duties, the Downstream Bioprocess Associate will contribute to process optimization and continuous improvement initiatives, applying standard work and lean manufacturing principles to enhance efficiency and quality. The role also supports achieving team Key Performance Indicators (KPIs) and sustaining a culture of operational excellence.
* This is a shift role.
Responsibilities
* Support operations team in achieving Key Performance Indicators (KPIs) such as EHS metrics, Production Plan, OEE, compliance, and training.
* Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures (SOPs).
* Ensure all manufacturing documentation complies with Good Manufacturing Practices (GMP).
* Maintain and update SOPs/Work Instructions (WIs) to align with regulatory standards and Right First-Time principles.
* Participate in safety programs, report and discuss safety concerns, and promote a strong safety culture.
* Take part in shift handovers and tier meetings, escalating issues promptly and suggesting resolutions.
* Provide cross-functional support to maintenance, engineering, quality, and other departments as needed.
* Engage in inspections, GEMBA walks, and Go-See activities to identify process improvements.
* Utilize Lean and Six Sigma tools to drive continuous improvement, increase efficiency, and reduce waste.
* Contribute to problem-solving and root cause analysis activities, applying past experience to determine effective solutions.
* Maintain a high level of technical expertise and understanding of manufacturing processes and equipment through continuous learning.
* Liaise with cross-functional teams to align manufacturing plans with overall site schedule and production goals.
* Support and uphold EHS, GMP, and quality compliance at all times.
* Participate as a trained Emergency Response Team (ERT) member during emergencies.
* Mentor and train new team members on plant processes and safety practices.
* Assist in audits and respond confidently to auditor queries during inspections or walkdowns.
* Foster a collaborative and high-performance culture by recognizing and celebrating achievements.
* Develop and manage production schedules based on equipment capacity, material availability, staffing, and demand forecasts.
* Ensure production output, quality, and compliance meet organizational and regulatory expectations.
* Execute preparatory and finishing production tasks in accordance with plans and procedures.
* Operate independently under moderate supervision, demonstrating technical proficiency and accountability.
Experience & Skills Required
* 2 Years of Downstream processing experience.
* Experience with GLIMS, SAP, and DeltaV
* Preferred – operation of filtration, chromatography, and buffer preparation systems.
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