Research Associate

Job Description

About PSC Biotech

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 points which includes the opportunity to work with the most talented cohort of like hearted 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 through 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

• Perform & document scientific experiments in collaboration with cross functional stakeholders as part of the BCoE or Site strategy, and/or in support of commercial & clinical product portfolio.

Requirements Responsibilities Laboratory / Project Work

• Executes defined procedures independently to support BCoE studies and investigative activities with lab scale upstream processes in the multi product lab.
• In addition to quick learning of core scientific techniques, principles and protocols, owns small project portions reliable execution and able to summarise findings.
• Understanding the principles of aseptic operation and experience working in biosafety cabinets.
• Experience in daily operations with microbial cell culture (E. coli), including cell thawing and cell banking, seed train expansion, etc.
• Experience in fermentation process, including fermenter inoculation, daily monitoring, sampling and in process analysis utilizing standard bioprocess analytical equipment.
• Basic understanding of mammalian cell expansion and its difference in comparison to microbial operations.
• Experience in processing of inclusion bodies is desirable.
• Produces accurate, reproducible data entries and maintains laboratory quality through adherence to safety and SOPs and able to troubleshoot common problems with guidance.
• Expands technical toolkit by adapting and troubleshooting process steps or assays, applies appropriate methods and interprets basic data trends.
• Updates and refines SOP/BPD documentation.
• Assists in drafting concise technical summaries.
• Understanding of fed batch and perfusion bioprocesses is desirable.
• Experience in depth filtration and ultrafiltration is desirable.
• Understanding of downstream purification process is desirable.

General

• Execute and complete projects independently.
• Generate and review data, make data analysis.
• Maintain up to date documentation of laboratory work carried out including documentation storage and archiving in accordance with GLP.
• Support updates of lab instructions, BPDs, SOPs, templates.
• Support maintenance and calibration of lab equipment with accompanying documentation.
• Contribute to the evaluation of new equipment. Be a teamplayer with excellent communication skills.
• Play an active role in maintaining and enhancing the safety of the workplace and the laboratories.
• Comply with applicable GxP regulations, SOPs, HSE, & other guidelines in the laboratory as applicable.
• May be required to work periodically out of normal business hours, including weekends.

Key Performance Metrics

• Adherence to project plans & deliverables
• Adherence to applicable GxP and EHS requirements
• Technical reports executed on time and on quality
• Efficient technical exchange with Project leads

Education

• Bachelor's degree or higher in Science or Engineering

Experience

• A minimum of 1 year experience in the pharmaceutical industry or equivalent strong laboratory experience.
• Working knowledge of pharmaceutical regulatory requirements appropriate to level and understanding of the cGMP manufacturing process for Biologics.