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Senior Manufacturing Engineer

4 months ago

San Diego, United States Tempo Therapeutics Full time

At Tempo Therapeutics, we are pioneering a new era in tissue engineering and regenerative medicine with our cutting edge Microporous-Annealed-Particle (MAP) technology platform. Our team is developing next generation biomaterials to build precision scaffolds for use in surgical reconstruction, organ regeneration, and even vaccine technology. Our mission is to harness the power of immunomodulation and use material science to transform the landscape of medical technology.


This is a unique opportunity to work in a fast-paced and challenging environment, while being an integral part of a team that is developing material science technology shaping the future of medicine. Our team is driven by the goal of changing patient lives for the better, and the successful candidate will share that driving force.


Job Summary:


The Senior Manufacturing Engineer works within Research & Development and is responsible for leading the development of manufacturing processes for medical devices to be transferred to CMO for manufacturing according to cGMP. Manages and executes process technology transfer, process validations from clinical to commercial production stages according to ISO standards and FDA regulations. Manages external vendors and service partners to ensure compliance, timelines, and budget are maintained. Supports development of innovative final product presentation solutions for delivery of novel biomaterial products.


Responsibilities:


Position will perform the following in a leading role:


Responsible for overseeing and optimizing the design and continuous improvement of manufacturing processes.


Design and implement process improvements to enhance product quality, yield, and efficiency.

Lead the process development team, providing support, oversight and training to manufacturing and lab personnel to ensure proper execution of manufacturing processes.


Management of oversite of terminal sterilization, and lyophilization.


  1. Oversite of aseptic filling process, support ongoing activities by assisting in troubleshooting mechanical/instrument problems, process issues and identifying improvements in operations to minimize interruptions, maximize utilization and supporting new and ongoing projects.
  2. Manage technology transfer activities to ensure smooth transfer of processes from development to CMO.
  3. Manage CMO’s to ensure compliance for clinical and commercial manufacturing programs.
  4. Develop process documentation such as standard operating procedures (SOPs), protocols and other similar GMP documents
  5. Develop and execute effective testing and method validation procedures for steps in the manufacturing process.
  6. Perform and manage facility qualification to evaluate and document the site, equipment and systems for suitability under GMP standards.


Support and contribute to the device master file (DMF) and design history file (DHF).


  1. Manage CMO’s to ensure compliance for clinical and commercial manufacturing programs.
  2. Perform vendor qualification and evaluation, and support vendor audits.
  3. Perform routine laboratory housekeeping, support inventory management, shipping, receiving, reconciliation activities.
  4. Other duties as assigned/needed
  5. Reports to Director of Research and Development


Qualifications:


Bachelor’s degree in chemical engineering, Biochemical Engineering, or a related field required.

5 - 10 years’ experience working within a manufacturing environment (cGMP of medical devices, biologics or pharmaceuticals) to support full product manufacturing lifecycle from pre-clinical, clinical, and commercial stages.


Extensive knowledge and experience in (must have):

  1. Experience with biomaterials
  2. Good manufacturing practices per 21 CFR 211
  3. Hands on bench work
  4. Process validation
  5. Experience interacting with the FDA to support inspections desired
  6. Manufacturing product lifecycle management
  7. Design controls via 21 CFR 820 and ISO 13485
  8. ISO 14971 Application of Risk Management
  9. Equipment validation
  10. MS Suite


Additional knowledge and experience in (pluses):


  1. Aseptic processing and validations
  2. Fill and finish
  3. Complex formulations
  4. Tangential flow filtration (flat sheet and hollow fiber)
  5. Sterile filtration