Senior Process Engineer

We’re looking for a highly motivated Senior Process Engineer to take on an important role in our dynamic and dedicated Process Development team. Reporting to the Head of Process Development, you will work on developing an aseptic manufacturing workflow for our bioprinted tissue therapeutics. You’ll be joining a company committed to developing regenerative medicines that deliver life-changing, functional cures for patients living with serious diseases.
Responsibilities
Leading the conceptualization, design, implementation and characterization of complex fluidic systems, bioreactor scaling strategies, and automated cell processing workflows (wash, concentrate, harvest) to reduce process risk and improve robustness.
Working with Process Development, Bioengineering, Engineering and Manufacturing to ensure seamless technical integration of the cell therapy process into the final device platform, focusing on closed-system design and single-use technologies.
Leading process risk assessments (e.g., FMEA, PHA) for both the cell manufacturing process and its interaction with the medical device component.
Developing mathematical models and implementing approaches such as DOE (Design of Experiments) to help define critical process parameters (CPPs) and critical quality attributes (CQAs).
Supporting technology transfer to Manufacturing including support for process qualification as well as assisting in early phase clinical manufacturing as needed.
Providing technical support for troubleshooting and participating in out-of specification and root cause analysis during manufacturing deviations or process improvements.
Working with our Quality team to define the validation strategies for sterilization, biocompatibility, and extractables/leachables (E&L) as well as providing the technical backbone for regulatory filings (CTA/IND).
Identifying gaps in current cell therapy manufacturing and developing patentable technologies to improve yield, purity, and scalability.
While an individual contributor role, you will mentor others and foster a culture of technical excellence and rigorous data-driven decision-making.
Qualifications
Education +

Experience:

M.S. or Ph.D. in Chemical Engineering, Bioengineering, Biomedical Engineering, or a related life science field with 6-8+ years of relevant industry experience, in cell therapy, bioprocess development, or biologics manufacturing.
Process Development & Characterization

Experience:

Strong hands-on background in the development, characterization, and optimization of biomanufacturing processes is required, preferably within cell therapy.
Process Engineering and Characterization:
Expertise in the design, implementation, and characterization of complex fluidic systems, including automated cell processing workflows (e.g., wash, concentrate, harvest). Proven ability to develop mathematical models and apply statistical methods (such as Design of Experiments, or DOE) for process characterization and defining Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
Bioreactors:

Experience with bioreactor systems and scaling strategies is desirable.
GMP & GDP Knowledge:
Thorough knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Familiarity with regulatory requirements for cell therapy products (e.g., providing technical content for CTA/IND filings).
Medical Device Knowledge:
Direct experience operating within a Design Control framework (e.g., FDA 21 CFR Part 820) for medical devices, specifically related to process inputs/outputs and risk management is desirable.
Technology Transfer:
Experience supporting technology transfer from Process Development to Manufacturing, including process qualification and validation activities (e.g., sterilization, E&L).
Analytical and Communication

Skills:

Strong analytical, problem-solving, and data-driven decision-making skills. Excellent written and verbal communication skills, including the ability to present complex data and mentor junior team members.
The hiring range for this role is $124,737 – $131,689, annually. Our ranges are based on market data. Offered salaries will be based on a combination of…