Description
Janssen Biologics B.V. is recruiting for a MSAT Engineering Fellow to be located in Sassenheim, the Netherlands.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity to be part of the team!
The Technical Process Owner serves as part of the Global Technical Team, reporting to the Global Head, LCM within the Advanced Therapies Manufacturing Science and Technology Organization. They are the single point of contact across the network of manufacturing sites 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.
Responsibilities:
- Serve as technical owner the Lentivirus network.
- Proactively monitor technical processes and product performance to detect trends and develop mitigation plans.
- Partner cross-functionally with the Value Chain Team (VCT), own the coordination of all technical activities for Lentivirus.
- Contribute to the development of the long-term supply strategy including scenario development and E2E impact analysis.
- Lead a multi-disciplinary team of technical experts across technical/operations/quality functions at the manufacturing site.
- Oversite of manufacturing investigation teams,
- Lead development of technical, quality, & compliance risk assessments/mitigation strategies and possible business continuity plans.
- In partnership with R&D, identify and oversee implementation of lifecycle management, new technology and automation projects at the manufacturing sites to improve process robustness and reduce COGS.
- Democratize process information across sites
Create/maintain modules to train operations/quality on scientific basis of the process.
- Oversite of investigation team and proactively identify and lead improvement/innovation opportunities
- Apply the science-based risk approach and regulatory intelligence to identify projects, benchmark against internal and external processes.
- Build business cases and prioritize product related projects across a network of manufacturing sites.
- Drive execution of technical projects, work across functions to development implementation strategy, including comparability and change control.
- Author/review technical reports, source documentation and filing sections to support product lifecycle and regulatory submissions
- Create, maintain, and upgrade product technical knowledge as an element of the value chain knowledge infrastructure
- Perform internal and external benchmarking activities
- 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
Qualifications
Experience
- Hands-on experience in Manufacturing Operation and/or R&D in a biopharmaceutical manufacturing setting (ie. 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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