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Scientist, Upstream Process Development - Biologics

Waltham, Massachusetts
Job Type
14 Jul 2022

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.

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Position Summary & Role:

  • Function as a key member of the Upstream Process Development group in Waltham, MA

  • Assist in building out and leading upstream operation of the Pilot 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 upstream bioprocesses for RESILIENCE Biologics partners and drive development and implementation of innovative internal technology platforms

Job Responsibilities:

  • Execute upstream technology strategies in various platforms including shake flasks, WAVE rockers, AMBR250, ERBI, bench-top bioreactors, 50L - 200L SUB Bioreactors

  • Support development and implementation of PAT control strategies such as RAMAN, NIRRIN, and Biocapacitance

  • Support continuous processing technology development

  • Assist in building out and leading upstream operation of the Pilot lab to enable Tox Lot production

  • Optimize monoclonal antibodies and other recombinant proteins for their fit within Resilience s mAb Platform Process

  • Develop processes for proteins that fall outside the Resilience s mAb Platform Process

  • Serve as upstream 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

Experience, Education & Qualifications :

  • Master s with 2-4 years or bachelor s with 6+ years of relevant experience in Biologics upstream process development

  • Strong understanding of the development and scale up of batch, fed-batch, and perfusion bioprocesses.

  • Experience with tech transfer of upstream processes

  • 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

  • Excellent data analysis and data management skills

Preferred Experience:

  • Experience with AMBR250 and Sartorius bioreactors

  • Experience with SIMCA (or equivalent) software, PLS, OPLS, PCA, MVDA statistical analysis

  • Strong knowledge of single use technologies

  • Experience with RAMAN spectroscopy

  • Able to apply 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

  • Intellectually 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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  • Job Reference: 658138778-2
  • Date Posted: 14 July 2022
  • Recruiter: Resilience
  • Location: Waltham, Massachusetts
  • Salary: On Application
  • Sector: Science & Technology
  • Job Type: Permanent