Lead Engineer of Downstream Process Development

Company Description: Isolere’s mission is to contribute to global health care equality by improving the quality and lowering the cost of biotherapeutics and vaccines. To accomplish this goal, we are completely rethinking traditional purification processes by adapting the power of naturally evolved separations phenomena into scalable, transformative manufacturing technologies. Isolere is a startup organization poised for significant growth.   

Role Summary: Isolere Bio is seeking a Lead Engineer of Process Development to validate, optimize, and scale up our technology, which combines affinity with liquid-liquid phase separation. Isolere’s phase separating materials can be designed to have exquisite specificity for specific biologic targets, such as antibodies, viruses, nucleic acids, and even cells. The phase behavior can be precisely tuned to achieve user-triggered phase separation on demand at ambient temperature. We are developing these reagents to have compatibly and scalable plug into existing downstream unit operations, such as tangential flow filtration and countercurrent centrifugation. The Lead Engineer of Process Development will work closely with Isolere’s executives, scientists, and technicians to develop robust, reliable, and scalable processes that yield high quality biologic products. The ideal candidate has significant experience with filtration and chromatography, as well as DoE, technology transfer, and scale up. Downstream process development experience with viral vectors is a plus.  As a member of a small startup team, this role will require a significant amount of hands on benchwork for the first 9-12 months as we get this program up and running. However, the role also has tremendous potential for growth and development by building robust processes and a team from the ground up and managing a complex, evolving, and commercially translatable development program.

Role Responsibilities:

» Work with the CSO, CEO, and advisors to develop platform downstream processes that use Isolere’s novel phase separating materials to concentrate and purify diverse biologic targets (various viral vectors, antibodies, nucleic acids). This includes identifying key technical risks and establishing appropriate timelines for bringing a scalable, platform process to market.

» Prioritize key parameters and design experiments to fundamentally understand the impact of Isolere’s material and end users’ harvest material variability on overall process performance.

» Optimize key process parameters and demonstrate technology’s scalability.

» Execute detailed comparison of Isolere’s technology to industry standard methods.

» Willing to spend a significant amount of hands-on time in the laboratory developing processes for at least the first 9-12 months.

» Assist in executing experiments and managing timely delivery of milestones for collaborations and other agreements with partners. 

» Train and manage existing employees as well as new hires as the Isolere R&D team grows.

» Communicate experiments and results effectively to executives within Isolere Bio and with external strategic partners

» Work with Isolere executives to set strategic direction of the technology and interface with collaborators and strategic partners to advance the technology towards commercialization as appropriate.

Basic Qualifications: Candidates of various education levels are encouraged to apply, provided they have highly relevant experience and confidence in their ability to take on a challenging role that will require creative problem solving.

PhD + 2 years of experience, MS + 5 years of experience, BS + 7 years of experience. Prior experience with tangential flow filtration and downstream process development is required. Prior experience with downstream process development of viral vectors and upstream process development is preferred. Experience with large batch volume processing, technology transfer, modeling, and cGMP adherence is a plus.

Candidates should highlight how their interests align with Isolere’s goal of developing innovative and more efficient ways to manufacture complex biologics. The candidate should also demonstrate their ability to solve problems independently, communicate effectively, handle multiple projects concurrently, and work with others on cross-disciplinary teams.

To apply for this opportunity, click "apply" and include the following:

• In the subject line: “Last Name – Application for Lead Engineer of Downstream PD”
• Resume or CV
• Cover letter
• Three personal references from past positions of employ

Applications that fail to meet these requirements will not be considered.