Tech Transfer Senior Specialist
Tech Transfer Senior Specialist
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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 cloudbased 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 likeminded 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 diversecultural work setting.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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.
An exciting opportunity has arisen for a Tech Transfer Sr. Specialist at facility. The Technology Transfer Senior Specialist will be a member of the Tech Transfer Delivery team reporting to the Technology Transfer Delivery Lead.
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.
Key Activities Within Role:
The Technology Transfer Specialist role will be a Change Champion within the organization and site to bring about new products digitization and ways of working.
Requirements
Primary Responsibilities:
- Collaborate with stakeholders to identify and execute the transfer requirements of programs. This may include late stage clinical and/or PPQ (Process Performance Qualification)
- Lead tier meetings to coordinate activities between local and international groups for implementation of new Drug Substance manufacturing processes
- Support development of process descriptions process models facility fits and other Tech Transferrelated documents for continuous and fedbatch processes
- Collaborate with stakeholders to deliver GMP documents related to TT such as: Risk assessments change controls and process design documents
- Improve local Tech Transfer procedures to streamline and standardize New Program Introduction ways of working while remaining compliant with the Quality Manual
- Assist in the development of future breakthrough business solutions to reduce overall effort / reduce risk to progress the team forward to oneclick tech transfer
- Embody Safe by Choice know and follow the Safety Health and Environment guidelines and work towards company safety and environmental goals
- Ensure the highest Quality Compliance and Safety standards.
Required Education Experience and Skills
- Minimum of 5 years of work experience in the pharmaceutical or biotech industry
- Bachelor s degree in: Biotechnology Engineering Chemistry or related field.
- Experience with project management with crossfunctional team members.
- Familiarity with upstream and/or downstream Unit Operations for mAb manufacturing
- Competent in analyzing complex situations and showing practical problemsolving capabilities
Preferred Experience and Skills:
- Minimum of 3 years of experience with quality management and compliance systems.
- Understanding of the general principles of New Product Introduction (Tech Transfer)
- Familiarity with the use of Automation systems in a manufacturing Process.
- Competency in the use of automated/digital systems such as DeltaV MES eVal
- Demonstrated experience in a GMPregulated biological drug substance manufacturing environment ideally with experience of singleuse systems.
- Validation experience including validation documentation generation and
- Familiarity with risk assessment processes
#LIPM3
Minimum of 5 years of work experience in the pharmaceutical or biotech industry Minimum of 3 years of experience with quality management and compliance systems. Understanding of the general principles of New Product Introduction (Tech Transfer) Bachelor s degree in: Biotechnology, Engineering, Chemistry, or related field.
Education
Minimum of 5 years of work experience in the pharmaceutical or biotech industry Minimum of 3 years of experience with quality management and compliance systems. Understanding of the general principles of New Product Introduction (Tech Transfer) Bachelor s degree in: Biotechnology, Engineering, Chemistry, or related field.
Employment Type
Full Time
