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: 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.
Requirements Reporting 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 group Working flexibility to support weekend work if required Support 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 memos Have 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 experience Minimum 2-3 years working in a biological, or vaccine clinical or commercial manufacturing Experience in cell culture process development and bioreactor operation Experience in downstream process development Experience in bioprocess development, biopharmaceutical production, and/or biological process validation experience with successful tracking record.
Biological production process validation experience will be an advantage Have knowledge and understanding of biopharmaceutical cGMP quality systems and operation Must have good interpersonal skills and the ability to communicate well with internal and external customers Have excellent written skill for validation study protocol, validation report, investigation/deviation report, SOP, and MBR Have excellent oral presentation skill for internal and external meeting Detail-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 validation Experience 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 Requirements Masters or Bachelor's degree in Biology, Biotechnology, Microbiology, Chemistry or Pharmaceutical Engineering or related Science or Engineering major or equivalent experience Minimum 2-3 years working in a biological, or vaccine clinical or commercial manufacturing Experience in cell culture process development and bioreactor operation