Process Development Group Lead - Gene Therapy

Job Description - Process Development Group Lead, Gene Therapy

• Responsible for operations and delivery of the Gene Therapy process development projects
• Coordinate/plan/execute the delivery of process development for gene therapy programs.
• Act as an upstream / downstream Subject Matter Expert (SME) in the organisation.
• Writing / adapting all relevant process development documents (e.g., process descriptions, protocols, reports).
• Responsible for completing technology transfers into GMP operations.
• Ability to identify and escalate issues as they occur, troubleshoot issues through technical expertise, and report accordingly with all relevant information.
• Manage a team of process development Team leads, including recruitment, training and coaching of the team.
• Technical and project-specific support to address regulatory and other key stake holder queries
• Actively evaluate and introduce, innovative and state of art technology with an aim to enhance overall technical capabilities of the Process Development team.
• Establish and implement stage appropriate compliance practices with aim to ensure data integrity and adherence to ALCOA requirements
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Education:

• Master's degree or PhD in related field.
• Ph.D. (or equivalent degree) and 9+ years of relevant post-doctoral employment experience, or
• Master's Degree (or equivalent degree) and 12+ years of relevant employment experience

Experience:

• Sound knowledge of process engineering and biotechnological processes & viral vector technology.
• Prior experience in industry, especially in mammalian cell culture and upstream process (bioreactors) development is strongly preferred
• Strong technical understanding and practical experience of product and process development with application of Quality by design strategy
• Experience with viral vectors would be advantageous
• Excellent problem-solving skills
• Excellent communication skills to communicate across multiple functional areas