Scientist I/II Downstream Process Development

Ensoma; Chicago (IL); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is looking for a motivated Downstream Process Development Scientist to join their team. This role focuses on the development and optimization of downstream processes critical for the successful production of biologics at scale. The ideal candidate will possess hands-on expertise in process development, scale-up, and tech transfer to commercial production environments. You will collaborate with cross-functional teams, lead process development activities, and ensure compliance with regulatory standards. If you are passionate about advancing biopharmaceutical manufacturing and thrive in a dynamic environment, this opportunity is perfect for you.

Qualifications

• PhD or Master's degree with relevant experience in process development.
• Hands-on experience with downstream unit operations is essential.

Responsibilities

• Develop and optimize downstream purification processes for biologics.
• Lead large-scale production runs and ensure quality standards are met.
• Manage tech transfers from R&D to commercial scale manufacturing.

Skills

Downstream Process Development

Process Optimization

Technical Leadership

Communication Skills

Troubleshooting

Adaptability

Education

PhD in Chemical Engineering

Master’s degree in Biotechnology

Tools

Unicron software

AKTA chromatography system

Job description

Position: Scientist I/II Downstream Process Development

Location: Boston, MA

Job Id: TBD

# of Openings: 1

Scientist I/II Downstream Process Development

We 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.