Scientist I/II Downstream Process Development

Company: Ensoma
Location: Boston
Posted on: April 1, 2025

Job Description:

Position: Scientist I/II Downstream Process DevelopmentLocation: Boston, MAJob Id: TBD# of Openings: 1Scientist I/II Downstream Process DevelopmentWe are seeking a highly skilled and motivated Downstream Process Development Scientist to join our team. In this role, you will be responsible for the development and optimization of downstream processes to ensure the successful production of biologics at scale. This position requires hands-on expertise in process development, scale-up, and tech transfer to commercial production environments.Responsibilities:

• Develop and optimize downstream purification processes for biologic products, ensuring the processes are scalable and reproducible.
• Lead process development activities for large-scale production runs, ensuring timelines and quality standards are met.
• Design, execute, and analyze experiments to improve process efficiency and product yield.
• Manage tech transfers of developed processes from R&D to pilot and commercial scale manufacturing.
• Work closely with cross-functional teams (e.g., upstream process development, quality control, and manufacturing) to ensure smooth integration of processes.
• Provide technical leadership during troubleshooting, root cause analysis, and continuous improvement initiatives.
• Prepare and review technical documentation, including protocols, reports, and regulatory submissions.
• Support compliance with cGMP, regulatory requirements, and internal policies during all stages of process development and tech transfer.
• Ensure seamless communication with team members to ensure alignment on project milestones and deliverables.Education/Required qualifications:
  • PhD degree in Chemical Engineering, Biotechnology, or related discipline with 0-2 years of relevant experience or Master's degree with 5-7 years of relevant experience.
  • Hands-on experience with downstream unit operations (clarification, chromatography separations, filtrations, ultracentrifugation).
  • Experience using the Unicron software as part of the AKTA chromatography system.
  • Excellent verbal and written communication skills.
  • Ability to handle multiple tasks and adapt to changing priorities.Preferred qualifications:
    • Experience/knowledge on viral vectors process development.
    • Experience with Design of Experiment (DoE) approaches and application to process optimization.
    • Knowledge of cGMP, FDA, and USP guidelines practices is preferred.About Ensoma:Ensoma is a place where you can ask the big questions. We look at gene therapy today and ask: What if we could eliminate the patient burden? What if we could treat diseases that affect millions? What if we could treat people anywhere around the world?Ensoma was founded to answer these questions. Our platform is the most advanced in vivo hematopoietic stem cell (HSC) engineering technology. It combines an off-the-shelf, in vivo delivery system with an advanced gene engineering toolkit. Through its HSC engineering platform, Ensoma can selectively and durably modify any cells of the entire hematopoietic system to treat diseases with unprecedented versatility - all with a one-time therapy. We believe the future of medicine lies within us - and this bigger, bolder vision for gene therapy needs incredible people to make it a reality.For our team, realizing this vision is personal. Founded and guided by leaders drawn from the top of the cell, gene therapy, and gene editing field, we feel an urgency and passion for our work driven by its potential global impact.A meeting at Ensoma is a space where curiosity, trust, authenticity, problem-solving, and professional development are celebrated. A career at Ensoma is an opportunity to be part of the team building the future of medicine.Ensoma is supported by top-tier investors, strategic partners, and a passionate team committed to a bold global vision for genomic medicines. Ensoma is headquartered in Boston, Massachusetts. For more information, please visit .
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Keywords: Ensoma, Boston , Scientist I/II Downstream Process Development, Other , Boston, Massachusetts