The Product Transfer Scientist will combine knowledge of chemistry, basic real-time PCR and a technical understanding of Cepheid chemistry and oligonucleotide manufacturing to play a key role in product sustaining and support within the Product Transfer group. This person will be the technical partner to the development and manufacturing teams throughout the life cycle of products. The Product Transfer Scientist represents Manufacturing/Operations in the cross-functional core teams for process validation requirements of new or optimized products/processes.
Identify and implement critical process parameters and apply process improvement tools including statistical process control charts, process capability studies, design of experiments and control plans. Contribute to root cause failure investigations and link with statistical process control program. Evaluate and recommend corrective actions in conjunction with Development and Manufacturing. Daily interaction and heavy engagement with Development, Manufacturing and other functions within Cepheid is expected for this role.
- Actively participate in the product development process as a representative of Product Transfer and Manufacturing for process validation and ensure compatibility with current and future manufacturing processes and capabilities.
- Lead, coordinate, or participate in operations-related activities required for the transfer of new products to routine production:
- Process validation
- Test method validation
- Process development/optimization
- Production scale-up
- Develop process validation plans, train personnel on validation requirements, investigate/track and document protocol deviations and nonconformances.
- Write, review, and approve the following: Process validation plans and reports, device master records, FMECA and reports, production procedures, DIRs and associated reports.
- Design process control plans, trend and maintain production process trending data to support maintenance of the validated state and continuous improvement efforts of the company.
- Coordination of multidisciplinary teams is often required.
- Provide coordination of Operation activities needed to support projects when required.
- Actively participate in risk assessments during the product development process and changes to production.
- As required, management of projects may be necessary. Project planning and timeline management.
- Bachelor's degree in Chemistry or related discipline.
- A minimum of 5-8 years of direct related experience in biotechnology, medical device or pharmaceuticals in a highly regulated environment.
- At least 5 years working in a cGMP environment applying ISO13485, ISO14971 and QSR regulations to the design control process.
- Strong proficiency in Word, Excel, PowerPoint, MS Project, Visio, statistical analysis (Minitab) and database (SQL) usage.
- Solid understanding in statistical process control techniques (DOE, process capability studies and control charts) and at least 3 years of experience implementing those techniques, control plans and production trending.
- Project coordination and organizational skills: ability to plan, prioritize, lead projects and drive projects to plan.
- Proven track record of successful project leadership and cross-functional project management in a regulated industry.
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