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: 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.
Requirements Responsibilities: 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 processes Employ 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 goals Ability 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 Transfer Familiarity 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 execution Competent 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 Requirements 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 Transfer Familiarity 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 execution