MSAT Engineer II

Job Description

Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company’s innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care.

Initially developing a portfolio of human acellular vessels (HAVs), to target multiple vascular markets including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Humacyte is focused on the development of future markets such as pediatric heart surgery, delivery of cellular therapies, and multiple other novel cell and tissue systems.

We are looking for additional colleagues to continue to build our expanding team. Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self‑motivated, with solid communication skills, and demonstrate the ability to work in a team environment and lead other professionals and peers.

The MSAT Engineer – Analytics will support the development and execution of process analytics, process support, and control strategy activities with limited supervision and guidance. This role will be ~50% process analytics and 50% process engineering support. This role will collaborate effectively with personnel in Manufacturing, Engineering, Process Development, Quality Assurance, and Quality Control utilizing strong communication, and technical expertise to maintain and improve manufacturing operations.

Not Remote

• Provides advanced level support for execution and development of the manufacturing control strategy and Process Analytics program
• Acquires, analyses, and reports data trends using graphical and statistical methods and utilizes expertise to make recommendations to next level management based on data analysis
• Develops systems and processes for the acquisition and analysis of data trends from process, equipment, and raw materials.
• Applies statistical process control techniques to independently develop and implement (following appropriate change control) process specifications, parameters, operating ranges, and action limits.
• Supports the execution of commercial manufacturing campaigns
• Provides guidance to others on advanced and/or moderately complex theory and concepts behind the process including an understanding of the impact of any process changes or improvements, as well as the impact of any process deviations or drift
• Proactively identifies technical issues on bioprocessing equipment and recommends activities to resolve the issue. Implements procedures and activities to prevent the same issue from occurring.
• Authors standard operating procedures, reports, and protocols and solicit next level manager approval for final documents

• Advanced knowledge of statistical process control methods and data interpretation
• Knowledge of multivariate modeling techniques
• Familiarity with data engineering concept for collection, storage, and validation of data
• Demonstrated technical foundation of cell- and tissue- based products and a strong familiarity with GMP manufacturing
• Able to independently troubleshoot advanced or moderately complex bioprocess activities and perform typical and atypical bioprocess optimization studies
• Possesses advanced knowledge of the cell biological aspects of the process, as well as the engineering and mass-transfer aspects of the process
• Possesses understanding and demonstrated knowledge of equipment and procedures and identifies potential problem before they occur

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll‑up‑the‑sleeves attitude and optimistic outlook
• Strong ability to work in a fast‑paced team…