BS in biology, cell biology, virology, biochemistry or related scientific discipline
Experience in production or process development for cell culture, vaccines or viral cell culture
Demonstrated experience in technology transfer, process validation, control strategy development for biopharm/vaccine processes.
Strong organisational and excellent interpersonal communication skills
Demonstrated effective technical writing skills
Demonstrable ability to work in multi-disciplinary, multi-cultural teams
Demonstrable ability to work independently.
Experience in recombinant viral vector production, gene therapy or cell therapy
Experience with establishment and oversight of GMP manufacturing in a late phase/commercial environment
Experience working with 3rd parties and developing/maintaining working relationships with these partners is critical
Experience of participating in risk assessments and development of product control strategy
Experience participating in investigations into quality incidents or deviations including root cause analysis, impact assessment and development of appropriate corrective and preventative actions
Experience generating reports supporting regulatory documentation
• Delivery of technology transfer to US manufacturing sites/CMOs
• Responsible for development of process validation master plans and protocols/reports
• Responsible for facilitating/conducting risk assessments to develop robust product control strategies for cell/gene therapy programs
• Responsible for management and successful closure of deviation investigations
• Responsible for supporting preparation of relevant sections of regulatory filings and responses to regulatory questions.
• Support capability build in other functional areas as needed
• Responsible for management of technical elements of the product lifecycle and continued process verification plans
• Responsible for successful interactions with contract manufacturing at third party sites. The role requires significant external engagement with 3rd parties (contractors, suppliers, academic and industry groups).
European and international travel will be required at times, as dictated by the project needs.
You may apply for this position online by selecting the Apply now button.
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