Scientist I - Bio Process Purification Development

Responsibilities

• Develop, optimize, and scale up purification processes for monoclonal antibodies, multi-specifics, antibody-like molecules, and other complex biologic candidates across early- and late-stage drug substance process development; independently design and execute experiments, interpret results, and recommend next steps.
• Support transfer of purification processes to GMP manufacturing sites for clinical material production, including preparation of technical documentation.
• Evaluate novel, advanced bioprocess technologies that are in line with the group's strategy.
• Plan and execute laboratory and scale-up activities efficiently, collaborating within the team and cross-functionally to meet project timelines and goals.
• Work with contract laboratories to plan and execute assigned viral clearance studies, interpret results, and contribute to technical documentation.
• Author technical reports and maintain complete, traceable experimental and batch records, including instrument and analytical data, in approved electronic systems; document results at execution and follow established procedures and timelines.
• Prepare and deliver technical presentations and group-meeting updates; critically evaluate experimental results, communicate recommendations, and promptly document and communicate significant deviations or unexpected results.
• Follow applicable laboratory and scale-up facility safety procedures and standard operating procedures (SOPs), complete required training before performing assigned activities, and contribute to laboratory readiness through equipment maintenance, cleanliness, and inventory management.

Qualifications

• Bachelor's degree with 5+ years of relevant industry experience or Master's degree with typically 2+ years of relevant industry experience (in Chemical Engineering, Biochemistry, Chemistry, or a closely related field, preferred).
• Must have protein purification experience including chromatography separations and filtration operations.
• Excellent attention to detail; ability to follow written experimental protocols and safety procedures and maintain accurate, complete, and traceable written records.
• Demonstrated ability to independently design, execute, and interpret critical experiments to answer scientific questions, troubleshoot purification operations, and recommend next steps.
• Demonstrated ability to learn, understand and master new experimental techniques.
• Able to work collaboratively within and outside of the group.
• Able to author technical reports and presentations.
• Has understanding of biochemistry and bioprocess engineering concepts.
• Strong planning and analytical skills, including the ability to critically evaluate experimental results and identify, document, and communicate significant deviations or unexpected results.
• Experience with AKTA chromatographic instruments (such as AKTA Avant, AKTA Purifier, AKTA Pure or similar).
• Demonstrated scientific writing skills and strong verbal communication skills including scientific data presentations.
• Proficiency with Microsoft Office and the ability to learn new software applications for experimental documentation, data analysis, and reporting.

Preferred

• Has hands on experience with executing antibody or antibody-like molecule purification techniques including resin chromatography (affinity, CEX, AEX, MMC), depth filtration, virus filtration, membrane chromatography, and TFF operations.
• Has hands on experience with monoclonal antibody or antibody-like molecule purification at GMP, pilot and/or laboratory scale.
• Understanding of analytical techniques, such as HPLC, LAL, and ELISA.
• Has hands on experience with high-throughput technologies and automation.