Senior Process Engineer

Senior Process Engineer

Are you eager to lead innovation in stem cell manufacturing? Are you experienced with stem cells, and scalable bioreactor based manufacturing processes? As a Senior Process Engineer at Cellistic, you’ll play a key role in developing and optimizing GMP-compliant processes for cutting-edge stem cell therapies.

Cellistic is growing, and we’re looking for passionate team members who believe in the power of engineered cells as medicines, challenge the status quo, and thrive on bringing novel ideas to life.

The position

As a Senior Process Engineer, you will drive the development of a novel allogeneic chimeric antigen receptor T (CAR T) cell manufacturing process. The Senior Process Engineer will serve as the process subject matter expert, lead development, and coordinate the integration of multiple unit operations. In this role you will focus on the scale-up (and automation) of bio-processes for manufacturing products from pluripotent stem cells to CAR-T cells.  The candidate will lead a multidisciplinary project team to execute the development plan, and support the technology transfer to GMP manufacturing team. This role will collaborate closely with multiple cross-functional teams including Analytical Development, Research, Supply Chain. 

As a major part of the job responsibility includes hands-on processes development, the preferred candidate is a highly motivated researcher with desire to work in a laboratory-focused role. 

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.
• Responsible to 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.
• Ability to manage various 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
• Must have 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 required from a small-scale cell culture process development perspective
• 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

Since we are working in an international environment, proficiency in English, both written and spoken, is a prerequisite.

As a person, you are open-minded and a good communicator by nature. You have a high level of energy that drives you and inspires your colleagues. You thrive in a changing and dynamic work environment, and in a job that requires you to be flexible, take initiatives and think out of the box when challenges occur. You are a true team-player who enjoys working in close collaboration with colleagues in and out of the laboratory.

Interested?

Send your motivation letter with curriculum vitae to: careers@cellistic.com