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:This role will be part of Manufacturing Self Directed
work team/ Hub in our new state of the art single use multi-product biotech
facility. The organisational structure at the site will be based on
self-directed work teams (SDWT) where decisions will be made at the level where
the data exists.The BTA is responsible for all procedures and processes
associated with the manufacture of Drug Substance at manufacturing facility, at
the highest standards of Safety, Quality and Compliance.The BTA will be responsible for undertaking manufacturing
operations involved in the production of biologic drug substance on their
designated shift. Key responsibilities include the execution of an automated
recipe using paperless technology in order to progress the drug substance
through inoculation and cell culturing activities, leading to filtration and
purification of the product in a state of the art single use technology based
facility. The incumbent will be involved in setting up the single use equipment
between runs, carrying out the production process according to world class GMP
and EHS principles. The BTA will also be involved in driving to optimise and
improve the processing activities through use of standard work and lean
processing techniques while supporting operations team to consistently deliver
on specific Key Performance Indicators (KPIs). At all times this role is
focused on delivery to the patient through living the culture including a
commitment to safety, focusing on right first time in everything we do and a
concentrating on the engagement and development of self and peers.This role is a site based role.This role will involve working shift, on a 24/7 basis.RequirementsResponsibilities:Participate in internal audit programs and risk
assessment compliance activity.implemented.Coach shift teams related to RFT documentation.Lead by example through coaching and mentoring on Production systems skill transfer.Coach CAPAs, Change actions/ SOP updates, training module
development/revision related to cell areaUtilise real-time data analytics for making decisions on
the value stream improvement intiatives.Troubleshoot and resolved issues and delaysLeads and participates in investigations arising from
manufacturing documentation aspects when required.Promote EHS leadership behaviours and engages employees
at all levels on EHS issues.Promote an environment where everyone speaks up for our
culture of safety and looks out for one another.Confirms that all activities have been correctly
completed by the end of shift such as Real-time batch record/ SAP Comet review
and elogs review.Be a visible leader of safety initiatives and stay
actively involved in safety forums.Act as a Cell Lead and be responsible for a unit
operation.Any other duties as and when assigned by the Manager. Skills & Education:Ability to interact with multiple stakeholders across
numerous departments.Excellent communication skills.Ability to manage multiple priorities and know when to
escalate issues for resolution.Excellent trouble shooting skills as well as an ability
to coach and mentor self-directed teams through complex problem solving.Level 7 qualification in a science or engineering
discipline, or Level 6 with a minimum of 1-3 years’ experience in a GMP
regulated Manufacturing environment.Experience of Upstream/ Downstream Processing.Experience in a highly regulated pharmaceutical
manufacturing environment would be desirable.Proven record of accomplishments in a regulated industry.Start-up experience in a large scale commercial drug
substance facility, or similar.#LI-AP1