Senior Engineer, Device Technology

Coherus Biosciences   •  

Redwood City, CA

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 50 days ago

Position Summary:

Developing and commercializing drug-device combination products and providing lifecycle manufacturing support.

Essential Duties and Job Functions:

  • Drug-device combination product development and commercialization
    • Work with device development organizations to ensure device development activities including design development, verification, validation, risk management, process validation, and human factors studies are executed per device regulations and industry standards
    • Work closely with drug product process development teams to ensure that filling and stoppering process capabilities are taken into consideration in device design and prefilled syringes are consistently manufactured to meet device design requirements
    • Lead device assembly equipment selection, qualification and process validation
    • Support drug-device combination product regulatory submissions
    • Act as a subject matter expert during regulatory agency interactions and partner audits
    • Oversee CMOs to ensure successful clinical and commercial GMP production of drug-device combination products
    • Provide technical support to resolve manufacturing deviations, conduct complaint investigations, implement corrective actions, review ongoing process monitoring and process improvements
    • Support quality in device stability planning
    • Manage projects from inception to commercialization
    • Travel as required to suppliers and manufacturing sites located around the world
    • Coordinate and attend kick-off meetings with CMOs and device organizations
    • Provide on-site support for trouble shooting and investigations

Knowledge, Experience and Skills:

  • Requires a BS/MSdegree in engineering or a related scientific field
  • 8-12 years of relevant experience industry experience in delivery device design & development and clinical/commercial manufacturing
  • Must have experience developing drug-device combination products
  • Prior experience and deep knowledge of a cGMP related industry is required, within the Biopharmaceutical or Pharmaceutical industry
  • Must have knowledge of applicable Quality and Regulatory guidelines
  • Must have experience with guiding GMP investigations at contract vendors
  • Must work well in cross-functional teams and be able to communicate effectively with external partners, peers, and senior management
  • Prior experience managing third party relationships
  • Must have strong negotiating and interpersonal skills, and the ability to clearly present recommendations
  • Excellent decision-making, leadership, interpersonal, written and verbal communication skills
  • Must have strong computer skills, including all MS Office applications
  • Must have experience with industry standard design and development tools (CAD, math modeling, tolerance analysis, and statistical software)