MS&T Scientist Specialist

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 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 MS&T Scientist Specialist is responsible for contributing to the overall running of the MS&T Bioprocess Laboratory and working across site as part of a diverse and interdisciplinary team to build capability and knowledge in the manufacture of biologics . Key responsibilities of the MS&T Scientist include the planning and execution of scale-down model establishment, analytical testing, satellite and improvement studies in the MS&T Bioprocess Lab, and the provision of technical expertise and leadership to support successful new  product introduction.

Requirements

Responsibilities :

• Plan and execute analytical testing to support USP-DSP scale-down model establishments, satellite runs and investigation / improvement studies in the MS&T lab
• Plan and execute   DSP laboratory studies (i.e. chromatography runs, filter assessments)
• Support the transfer of analytical methods into the MS&T laboratory.
• Provide specialist analytical support to the site and the network for non-routine analysis and troubleshooting.
• Experimental design, execution, data analysis and interpretation.
• Author and review standard operating procedures and technical reports
• Supporting multidisciplinary teams (MS&T, quality, analytics, regulatory) for process improvement and troubleshooting.
• Assuring effective application of Lean SixSigma and Change Management tools in the Analytical Sciences group by :
• Securing continuity of an appropriate level of knowledge.
• Facilitating problem solving & risk assessment (FMEA) projects / meeting.
• Making problems visible and striving for continuous improvement.
• Serving as an analytical specialist during internal audits and external inspections / audits.
• Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.
• Ability to lead and coach others to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
• Excellent trouble shooting and problem-solving skills as well as influencing, collaboration skills and teamworking ability to represent MS&T on global and interdisciplinary teams.
• Complete product robustness monitoring in partnership with global technical teams and provide leadership for investigations.
• Demonstrate “safety first, quality always” mindset in all responsibilities.

Educational and Experience Requirements :

Other Job Requirements :

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Requirements

Plan and execute analytical testing to support USP-DSP scale-down model establishments, satellite runs and investigation / improvement studies in the MS&T lab Plan and execute DSP laboratory studies (i.e. chromatography runs, filter assessments) Support the transfer of analytical methods into the MS&T laboratory. Provide specialist analytical support to the site and the network for non-routine analysis and troubleshooting. Experimental design, execution, data analysis and interpretation.