Senior Manufacturing Engineering Director
23 hours ago
Vitalbio seeks an exceptional leader to spearhead the development and implementation of cutting-edge manufacturing processes. As Senior Manufacturing Engineering Director, you will be responsible for leading a high-performing team in establishing and maintaining cGMP compliant manufacturing processes, ensuring seamless technology transfer, and driving process improvements.
About the Role:
- Provide strategic leadership to the Manufacturing Process Development team, fostering a culture of innovation and excellence.
- Collaborate with cross-functional leaders to develop and execute strategies for product development, design transfer, and production scale-up.
- Lead the development and implementation of lean and Six Sigma methodologies to drive efficiency and quality improvements.
- Manage communication of requirements, scope, and hand-offs for various transfer activities, ensuring effective collaboration across teams.
- Establish timelines and milestones for manufacturing process development activities, ensuring alignment with the overall development schedule.
- Identify technical and schedule risks, and implement effective countermeasures to mitigate their impact.
Requirements:
- Bachelor's Degree in a relevant field (e.g., Mechanical Engineering, Chemical Engineering).
- 10+ years of industry experience in introducing new products and processes into manufacturing, with specialized knowledge and experience in cGMP manufacturing in the IVD space.
- Demonstrated ability to plan and execute tech transfer, process development, and scale-up of new technologies and processes effectively for combination products for Diagnostics.
- Familiarity with global IVD regulations related to the manufacture of instruments, reagents, and consumables for IVDs, validation/qualification requirements, and recordkeeping.
- Excellent communication skills, attention to detail, and strong organizational skills.
- Proven ability to build effective teams and participate in multi-disciplinary teams.
What We Offer:
- A competitive compensation package, estimated at $120,000 - $180,000 per annum, commensurate with experience.
- A collaborative environment with a high-performing team dedicated to innovation and excellence.
- An opportunity to shape the future of medical diagnostics and make a meaningful impact on global healthcare.
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