Scientist, Downstream Process Development - Biologics

Resilience (Resilience US, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients’ lives.

For more information, visit www.resilience.com.

Position Summary & Role:

RESILIENCE is seeking a talented Scientist I in Downstream Process Development for the Biologics Franchise who will:

• Function as a key member of the Downstream Process Development group located in Waltham, MA
• Assist in the build out and lead downstream operation of the Pilot scale lab to enable Tox Lot production
• Work collaboratively with other leaders throughout the network to advance objectives, priorities, and disruptive technologies
• Operate with the mission to transfer and develop robust, scalable, cost-effective therapeutic protein purification processes for RESILIENCE Biologics partners and drive development and implementation of innovative internal technology platforms

Job Responsibilities:

• Execute world-class downstream technology strategies from bioreactor recovery, affinity-column purification, impurity removal, viral inactivation and filtration, UF/DF, and sterile filtration.
• Assist in the build out of Resilience’s Pilot Scale Lab and play a lead role in scaling up developed processes from bench to pilot scale for Tox Lot generation
• Investigate the full design space to advance and develop new methods to purify recombinant proteins, and leverage any relevant methods or technologies towards improving Resilience’s Platform Processes
• Assess and optimize monoclonal antibodies and other recombinant proteins for their fit within Resilience’s mAb Platform Process
• Develop modified or unique processes for proteins that fall outside the Resilience’s mAb Platform Process
• Serve as downstream SME on cross functional project teams
• Assist with organizing and streamlining work activities, including:
  • Ensuring adequate and appropriate inventory of materials and supplies
  • Ensuring equipment is appropriately maintained and calibrated
  • Interacting with suppliers on design, procurement and testing of PD equipment
  • Ensuring documentation and data management practices are followed, reviewing documentation
• Support collaborations with partners, technology developers, and suppliers
• Mentor and assists junior scientists with day-to-day lab operations

Preferred Experience, Education & Qualifications:

• PhD with 0-2 years, Master’s with 2-4 years or Bachelor’s with 4-6 years of relevant experience in Biologics downstream process development
• Background in the development and scale up of various purification methods: column chromatography purification, nano filtration, depth filtration, UF/DF, sterile filtration,
• Understanding of recombinant protein downstream process development, scale up and technology transfer
• Experience with process characterization and Design of Experiments (DOE)
• Understanding of regulatory requirements and trends related to therapeutic protein process development
• Understanding of early and late-stage process development
• Excellent writing and verbal communication skills
• Applying scientific principles and concepts to potential innovative platforms and disruptive technologies
• Experience in customer-facing environment
• Strategic and innovative thinker; track record of fresh insightful thinking by developing creative approaches to processes and practices
• Track record of participating in teams that drive DS/CMC strategy for the development of therapeutic recombinant protein programs

Other Ideal Personal Characteristics:

• Hungry, humble, and a learning machine with an open, inquisitive mind with regard to the future of medicine and biomanufacturing
• Embodies grit, rigor, service, EQ+IQ, builder mentality, velocity, and ownership
• Smart, curious, flexible, able to contribute at a very high level, as well as possessing a hands-on manner, when necessary
• Collaborative style, with an ability to build consensus among both internal and external stakeholders

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