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Job: Process Development Research Scientist / PD Engineer, Isolere Bio, Inc., Durham, NC

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General Information


Job title:
Process Development Research Scientist / PD Engineer
Job location:
Durham, NC  27701 United States
Requisition code:
Date posted:
09/29/2021
Compensation:
Salary is commensurate with experience and includes health care, retirement, and stock options plans as well as flexibility with working hours and PTO. Relocation assistance is available.
Job category:
Product Development
Engineering
Process Development
Research and Development
Materials Management
Manufacturing and Production
Employment type:
Full time

Job Description


Location: Chesterfield Building, 701 West Main Street, Durham, NC 27701 (https://goo.gl/maps/UhgTQ6YJTvdZvcB57)

Salary and Relocation Assistance: Salary is commensurate with experience and includes health care, retirement, and stock options plans as well as flexibility with working hours and PTO. Relocation assistance is available.

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 Process Development Scientist or Engineer 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 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 scale linearly and plug into existing downstream unit operations, such as tangential flow filtration (TFF). In this position, the candidate will work closely with Isolere’s management team, scientists, and technicians to develop robust, reliable, and scalable filtration processes that yield high quality biologic products. The candidate may be required to travel to end-user sites to assist the adoption of our technology. The ideal candidate has significant experience with filtration and chromatography, as well as DoE, technology transfer, scale up, and GMP. Downstream process development experience with viral vectors in an industry setting is a plus.

Travel Expectation: 10-20%

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.
» Evaluate key process parameters and optimize TFF process performance
» Perform proof of concept testing to evaluate Isolere’s next-generation manufacturing concepts
» Analyze process performance data and make suggestions for next steps
» Communicate results effectively to supervisor and produce slide decks that clearly communicate experimental design and key outcomes
» Help with general laboratory and equipment maintenance and upkeep

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.
MS + 1 years of experience, BS + 2 years of experience. Prior experience with tangential flow filtration and downstream process development is required and performance of these unit operations at large scale is preferred. Prior experience with downstream process development of viral vectors is preferred and additional experience with upstream processes is a plus.
Candidates should highlight how their interests align with Isolere’s technology and the company’s goal of developing innovative and more efficient ways to manufacture complex biologics. Candidates should also demonstrate their ability to solve problems independently, communicate effectively, handle multiple projects concurrently, and work with others on cross-disciplinary teams.

Job Requirements


Role Summary: Isolere Bio is seeking a Process Development Scientist or Engineer 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 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 scale linearly and plug into existing downstream unit operations, such as tangential flow filtration (TFF). In this position, the candidate will work closely with Isolere’s management team, scientists, and technicians to develop robust, reliable, and scalable filtration processes that yield high quality biologic products. The candidate may be required to travel to end-user sites to assist the adoption of our technology. The ideal candidate has significant experience with filtration and chromatography, as well as DoE, technology transfer, scale up, and GMP. Downstream process development experience with viral vectors in an industry setting is a plus.
Travel Expectation: 10-20%
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.
» Evaluate key process parameters and optimize TFF process performance
» Perform proof of concept testing to evaluate Isolere’s next-generation manufacturing concepts
» Analyze process performance data and make suggestions for next steps
» Communicate results effectively to supervisor and produce slide decks that clearly communicate experimental design and key outcomes
» Help with general laboratory and equipment maintenance and upkeep
(Job number: 4051476)
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