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 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: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.RequirementsResponsibilities:Plan and execute analytical testing to support USP-DSP
scale-down model establishments, satellite runs and investigation/improvement
studies in the MS&T labPlan 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 reportsSupporting 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: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 lab-based role. #LI-KV1