Technology Transfer Specialist
Technology Transfer 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.
Overview:
- An amazing opportunity has arisen for a Specialist within the Technology Transfer Delivery Team at our new state of the art single use multiproduct 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 multiproduct 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 rightfirsttime.
- 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 Transferrelated documents for continuous and fedbatch 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 problemsolving 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 GMPregulated biological drug substance manufacturing environment ideally with experience of singleuse systems.
- Validation experience including validation documentation generation and
- Competent in analyzing complex situations and showing practical problemsolving capabilities
- Ability to work as part of a team and on own initiative in a constructive manner.
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
Education
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.
Employment Type
Full Time
