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:An amazing opportunity has arisen for a Specialist,
within the Technology Transfer Delivery Team, at our new state of the art,
single use, multi-product facility.The Technology
Transfer Delivery group will work closely with external stakeholders as well as
internal partners such as Process Engineering, Quality, Operations, Process
Automation and Development to deliver seamless NPI to our multi-product
facility.The successful candidate would be a responsible for
supporting New Product Introduction, while also acting as a key contributor to
the evolving site tech transfer strategy. They will also act as a Change
Champion within the organization and site, to bring about new products,
digitization, and ways of working.RequirementsResponsibilities:Collaborate with stakeholders to execute the transfer
requirements of both late stage clinical and/or PPQ (Process Performance
Qualification) programs.Attend meetings with local and international groups to
coordinate and execute implementation tasks for new Drug Substance processes.Manage new program introduction schedule to ensure tasks
are executed on schedule and right-first-time.Collaborate with stakeholders to deliver GMP documents
related to TT, such as Risk assessments, change controls, batch records,
sampling plans, Bills of Material.Support development of process descriptions, process
models, facility fits, and other Tech Transfer-related documents for continuous
and fed-batch processesEmploy innovative and continuous improvement mindset to
identify and implement opportunities to enable product launch.Ensure the highest Quality, Compliance and Safety
standards and embody Safe by Choice – know and follow the Safety, Health and
Environment guidelines and work towards company safety and environmental goalsAbility 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 work with
global and interdisciplinary teams. Skills and Qualifications Required:Minimum of 3 years of work experience in the
pharmaceutical or biotech industry Bachelor’s degree in Engineering, Biotechnology,
Chemistry, or related field.Technical knowledge with Biologics drug substance
upstream and downstream operations or process development.Understanding of the principles and activities of New
Product Introduction NPI/Tech TransferFamiliarity with the use of Automation systems in a
manufacturing Process such as DeltaV, MES, eVal as well as business tools such
as Power Project and Power BI.Demonstrated experience in a GMP-regulated biological
drug substance manufacturing environment, ideally with experience of single-use
systems.Validation experience including validation documentation
generation and executionCompetent in analyzing complex situations and showing
practical problem-solving capabilities Ability to work as part of a team and on own initiative
in a constructive manner.#LI-KV1