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Job Function:
Project/Program Management Group
Job Sub Function:
Project/Program Management
Job Category:
Professional
All Job Posting Locations:
Ghent, East Flanders, Belgium
Job Description:
The Technical Owner serves as part of the Global Technical Team, reporting to the Global Process Owner within the Advanced Therapies Manufacturing Science and Technology Organization. They are the single point of contact at the manufacturing site for the technical team, responsible for driving implementation of key initiatives related to the product technical roadmap and lifecycle management plan for the Advanced Therapies Supply Chain portfolio of products. Example focus areas include projects that will drive reliability, innovation and sustainability in our processes and plants, both internally and externally. Cross-functional partnership with R&D, Quality, and Regulatory will be required to ensure processes meet the needs of today and tomorrow.
ESSENTIAL FUNCTIONS:
- Partner cross-functionally with the Value Chain Team (VCT), owning the coordination of all technical activities.
- Contribute to the development of the long-term supply strategy including scenario development and E2E impact analysis
- Lead the development of technical, quality, & compliance risk assessments/mitigation strategies and possible business continuity plans
- Collaborate with R&D, site functions and finance to identify COGS improvement opportunities (COGS optimization process)
- Lead improvement/innovation opportunities, to build project business cases and to prioritize projects (product related)
- Proactively monitor technical process and product performance to detect trends and develop mitigation plans
- Democratize process information across sites
- Author “why” modules and train operations/quality on scientific basis of the process
- Support failure investigations (escalation of quality or compliance events)
- Execute or follow-up on execution of technical projects
- Present to health authorities during inspections
- Develop validation approaches and technical strategy for implementation of key initiatives
- Maintain a robust technical support network related to lifecycle management, new technologies, automation, comparability, change management and tech transfers for product
- Identify and oversee implementation (in partnership with R&D) of lifecycle management, new technology and automation projects at the manufacturing sites to improve robustness, scalability and cost/cycle time/quality performance for approved products
- Partner cross-functionally and champion to develop strategies for comparability exercises to enable change implementation
- Ensure technical and manufacturing product requirements are addressed throughout lifecycle of new solutions
- Author and review technical reports, source documentation and filing sections to support product lifecycle and regulatory submissions
- Apply the science-based risk approach and regulatory intelligence
- Manage a multi-disciplinary team of technical experts across technical/operations/quality functions at the manufacturing site
- Create, maintain, and upgrade product technical knowledge as an element of the value chain knowledge infrastructure
- Perform internal and external benchmarking activities
- Reviews technical product & process risk profiles and criticality analysis
- This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.
AUTONOMY AND COMPLEXITY:
- Represent the area for site wide/global projects as required.
- Lead troubleshooting of routine manufacturing processes.
- Endlessly curious, seeking to understand the “why” behind complex scientific topics
- Develop, lead and influence implementation of innovative solutions to ensure competitiveness, product quality and process capability improvements
- Can-do mentality, agility & high flexibility able to work with stretched goals and deadlines
EXPERIENCE
- Hands-on experience in Manufacturing Operation and/or R&D in a biopharmaceutical manufacturing setting (i.e.. cell/gene therapy products, vaccines, or any other advanced therapy products)
- Experience leading the coordination of tech transfer activities and technical services for cell/gene therapies
- Expert knowledge of cell and gene manufacturing processes
- Expert knowledge of GMP/quality considerations for commercial manufacturing
- Expert knowledge of evolving ATMP health authority expectations/regulations
- Expert knowledge of data analytics/sciences and process automation
EDUCATION AND EXPERIENCE:
- University/Bachelors Degree in Science/Engineering or Equivalent with 8-10 Years Biotech/ Pharmaceutical experience or equivalent industry experience
OR
- Masters/PhD degree in Engineering, with 4-6 years Biotech/ Pharmaceutical experience or equivalent industry experience
OTHER SKILLS, ABILITIES OR QUALIFICATIONS:
- Works in an international environment across different time zones
- Travel: up to 20% - project dependent
- Knowledge of Data Analytics/Statistical Analysis Tools
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