Scientist, Upstream Process Development - Biologics
- Employer
- Resilience
- Location
- Waltham, MA
- Start date
- Sep 28, 2022
View more
- Discipline
- Engineering, Manufacturing & Production, Science/R&D, Biotechnology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown
Job Details
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:
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
Company
Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development. For more information, visit www.Resilience.com and follow us on Twitter @IncResilience
- Website
- http://www.resilience.com/
- Location
-
9310 Athena Circles
La Jolla
CA
92037
United States
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