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:MS&T Bioprocess lead supports the development of the
site, providing leadership and Drug Substance technical support, in the Process
Sciences Laboratory. Leads/participates in cross functional teams to deliver
all project and investigational activities on schedule. The successful
candidate will develop a talented team of Manufacturing Science &
Technology Scientists in delivery of new products for commercial operations.Hybrid model potentially 2 days remote working RequirementsResponsibilities:Reporting to the Manufacturing Science & Technology
Laboratory Lead, the responsibilities include, but are not limited to the
following:Manage, coach, and mentor the MS&T drug substance
team in performing advanced technical experiments. Inspire, reward and develop
individuals, helping them to reach their potential.Technical Lead for MS&T Process Sciences and the
site.To provide proactive, technical oversight of the
biologics inline & pipeline products.Lead technical assessments for process investigations,
risk assessments, evaluation of specifications and material qualification. Coach the team on development and execution of technical
studies, continuous improvement of existing biologics processes and for new
product launch.Complete experimental design, execution, data analysis
and interpretation for improvement programs.Oversight of the product robustness trends observed in
commercial operations and alignment with laboratory models, such as SIMCA for
multivariate data analyses.Lead and/or support deployment and use of various digital
tools at the facility: Leverage these tools to deliver business value through
predictive/proactive issue resolution, rapid investigation closure, improved
yield/throughput.Assist in the regulatory authoring and review of
technical documentation, technical report writing and global regulatory
submissions.Support creation of the laboratory budget and review
actual performance against forecast. Skills & Education Required:Ideally a Master’s in Biological Sciences/ Chemical
Engineering/ Biological Engineering/Chemistry.8+ years directly related working knowledge in academia,
pharmaceutical or biotechnology company – along with a working familiarity of
current regulatory requirements and current Good Manufacturing Practices.The successful candidate will also have demonstrated the
ability to deliver projects and programs, with a strong understanding of lean
and laboratory operations.Excellent oral and written communication skills, with the
ability to effectively articulate understanding of process science to drive
decision making, impact assessments, design of studies in a multi-disciplinary
team environment. #LI-PM3