MS&T Scientist (Upstream)
MS&T Scientist (Upstream)
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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 cloudbased 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 likeminded 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 diversecultural work setting.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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:
- This role is part of the Manufacturing Science and Technology (MS&T) hub at our stateoftheart singleusemultiproduct facility.
- 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 scaledown model establishment in upstream/downstream 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 upstream activities (USP) for scaledown model establishments satellite runs and investigation/improvement studies in the MS&T lab (i.e. vial thaws shake flask passaging benchtop bioreactor operations including inoculation sampling feeding and harvest)
- Support the transfer of new products (NPI) into the MS&T laboratory.
- Provide upstream specialist support to the site and the network for nonroutine analysis and troubleshooting.
- Experimental design execution data analysis and interpretation through DOEs.
- 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 MS&T lab team 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 upstream 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 problemsolving 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:
- Bachelor of Science degree qualification with minimum 5 years of experience Master of Science degree qualification with minimum of 3 years experience or PhD degree qualification (scientific discipline in biotechnology biochemistry pharmacy process engineering or equivalent).
- Technical expertise with biologics drug substance upstream and downstream operations analytical testing process development and tech transfer.
- Proven ability to work as part of a team but also on own initiative as well.
- Ability to think logically and be proactive under pressure.
- Effective communicator and deep technical expertise in science.
- Proven ability around working cross functionally focusing on meeting and tracking to schedules and embracing an interdependent work culture.
- Experience working in a GMP / regulated environment is desirable.
- Organisation Skills Ability to manage multiple priorities and know when to escalate issues for resolution.
Other Job Requirements:
- This role is a site and labbased role.
- Rotational: 1 weekend per month Saturday and Sunday days
Bachelor of Science degree qualification with minimum 5 years of experience, Master of Science degree qualification with minimum of 3 years experience, or PhD degree qualification (scientific discipline in biotechnology, biochemistry, pharmacy, process engineering or equivalent). Technical expertise with biologics drug substance upstream and downstream operations, analytical testing, process development and tech transfer. Rotational: 1 weekend per month - Saturday and Sunday days
Education
Bachelor of Science degree qualification with minimum 5 years of experience, Master of Science degree qualification with minimum of 3 years experience, or PhD degree qualification (scientific discipline in biotechnology, biochemistry, pharmacy, process engineering or equivalent). Technical expertise with biologics drug substance upstream and downstream operations, analytical testing, process development and tech transfer. Rotational: 1 weekend per month - Saturday and Sunday days
Employment Type
Full Time
