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:As a process scientist in vaccine manufacturing MSAT lab
your primary role will be to provide process support to upstream and downstream
lab scale experiment planning and execution.RequirementsReporting to: Superior positions：This
role will be reporting to the Technical Lead of the MSAT.Subordinate positions：Individual Contributor
position Responsibilities:Lead and support upstream and downstream related studies
at small scale in MSAT lab.Strong background in setting up cell culture seed train,
bioreactors setup and running process smoothly.Strong background in TFF, clarification, filtration and
dilution of drug substance. Write reports to a high standard and present data within
the groupWorking flexibility to support weekend work if requiredSupport manufacturing to perform any study required
during, engineering, validation or clinical batches.This role will support satellite runs of vaccine process
to ensure the efficient and consistent production of vaccines.The ideal candidate will possess a deep understanding the
drug substance process as well as a passion for problem-solving and process
improvements in a GLP environment. Ensure a high standard of record keeping and
documentation of experiments and investigations.Support in drafting SOP, protocols, MBRs and other
technical documents and revision of documents including technical memosHave in depth knowledge of vaccine drug substance process
and understand the basis of specification and critical attributes.Participate in manufacturing investigations with
cross-functional teams to ensure that detailed root cause analysis is completed
and appropriate CAPAs are implemented.This role will partner with the MSAT team and DS
Technical team to provide comprehensive technical leadership to DS
manufacturing. Support equipment qualification deliverables during
execution of project phase including equipment Commissioning &
Qualification, IOQ. Work closely with manufacturing, and quality teams to
ensure smooth and robust process. Identify and implement projects to continuously improve
the compliance and manufacturing capabilities within the DS MSAT lab area Qualification & Skills, Experience required:Masters or Bachelor’s degree in Biology, Biotechnology,
Microbiology, Chemistry or Pharmaceutical Engineering or related Science or
Engineering major or equivalent experienceMinimum 2-3 years working in a biological, or vaccine
clinical or commercial manufacturingExperience in cell culture process development and
bioreactor operationExperience in downstream process developmentExperience in bioprocess development, biopharmaceutical
production, and/or biological process validation experience with successful
tracking record.Biological production process validation experience will
be an advantageHave knowledge and understanding of biopharmaceutical
cGMP quality systems and operationMust have good interpersonal skills and the ability to
communicate well with internal and external customersHave excellent written skill for validation study
protocol, validation report, investigation/deviation report, SOP, and MBRHave excellent oral presentation skill for internal and
external meetingDetail-oriented organizational skill to track and
maintain project activities Experience in troubleshooting and investigating critical
deviation, performing risk analysis on production process, coordinating
technical transfer, and executing process validationExperience in drug substance manufacturing that include
cell culture, biologics purification etc.Hands-on experience in Upstream cell culture and
bioreactor process,Downstream clarification and purification process and Drug
substance manufacturing support. #LI-AP1