Overview
Senior Process Engineer at Cellistic, you’ll play a key role in developing and optimizing GMP-compliant processes for cutting-edge stem cell therapies.
Are you eager to lead innovation in stem cell manufacturing? Are you experienced with stem cells, and scalable bioreactor based manufacturing processes? This role focuses on the scale-up (and automation) of bio-processes for manufacturing products from pluripotent stem cells to CAR-T cells, and involves leading development and coordinating the integration of multiple unit operations.
Responsibilities
* Develop pioneer processes and introduce state-of-the-art technologies to manufacture iPSC-derived T-cells therapeutics.
* Evaluate and implement technology to enhance consistency, scalability and cGMP compliance of bio-processes for manufacturing iPSC-derived T-cell therapeutics.
* Leverage high throughput experimental designs and equipment (from deep well plates to small scale bioreactors) to optimize cellular differentiation and optimize for product quality.
* Develop scale-down models for process optimization studies.
* Evaluate and implement process analytic technologies (PAT) for improved monitoring and control of stem cell bio-processes.
* Plan technical work packages and deliver them according to quality and delivery targets, in alignment with the project manager.
* Write protocols, technical reports, and Standard Operating Procedures (SOPs).
* Participate in technology transfer of processes and equipment to the Manufacturing group.
* Collaborate with project teams to integrate processes.
* Manage multiple priorities in a fast-paced and growing environment.
* Document, share, present and communicate study results at meetings and in other formats.
Qualifications
* Ph.D. and 10+ years or MS and 15+ years of experience in bioengineering, chemical engineering, biology, biochemistry or related field.
* Industry and project management experience; direct, hands-on industrial upstream experience (ideally in gene and/or cell therapy process development).
* Strong industrial upstream processing knowledge for small-scale cell culture process development.
* Industrial experience with biologics, gene and/or cell therapy upstream process development including ownership of key process decisions. Prior experience with different modes of cultivation such as fed batch and perfusion (ATF, TFF) desired.
* Prior experience with primary cells, T or NK cell culture, stem cells (including hematopoietic stem cells), and/or stem cell differentiation desired.
* Strong organizational, troubleshooting and interpersonal skills along with excellent oral and written communication.
* Demonstrated ability to work in a fast-paced, collaborative, and matrixed organization environment.
* Ability to work a flexible schedule as weekend work is required.
* Proficiency in English, both written and spoken.
Application Process
Interested candidates should submit their resume and cover letter outlining qualifications and experience to careers@cellistic.com.
Cellistic is an equal opportunity employer committed to creating an inclusive environment for all employees.
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