Scientist Downstream Process Development - Biologics

Profile

**MEMBERS ONLY**SIGN UP NOW***. (**MEMBERS ONLY**SIGN UP NOW***. 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. **MEMBERS ONLY**SIGN UP NOW***. 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, **MEMBERS ONLY**SIGN UP NOW***. frees partners to focus on the discoveries that improve patients’ lives.

For more information, visit ****target=_blank rel=no-follow>****Summary & Role:

**MEMBERS ONLY**SIGN UP NOW***. 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 **MEMBERS ONLY**SIGN UP NOW***. 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 **MEMBERS ONLY**SIGN UP NOW***.’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 **MEMBERS ONLY**SIGN UP NOW***.’s Platform Processes
• Assess and optimize monoclonal antibodies and other recombinant proteins for their fit within **MEMBERS ONLY**SIGN UP NOW***.’s mAb Platform Process
• Develop modified or unique processes for proteins that fall outside the **MEMBERS ONLY**SIGN UP NOW***.’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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