Sr. Process Engineer

Position Summary

AskBio is seeking a Sr. Process Engineer, Manufacturing Science and Technology (MSAT) to join our Process Engineering team and support current and future commercialization efforts. This position supports scale-up, technology transfer of AskBio's portfolio of gene therapy products into cGMP manufacturing for clinical production, process validation and commercial launch. The incumbent will onboard clinical programs into the MSAT laboratory, perform scale-up runs, and transfer programs to AskBio's contract manufacturing facility. Additionally, this position will be responsible for performing Phase III clinical enabling activities including scale-down model development, process characterization, and process control strategy definition to enable process performance qualification (PPQ) readiness for both drug substance and drug product manufacturing campaigns. This position is highly collaborative and will require internal and external team interactions to ensure successful process scale-up, technology transfers, and cGMP manufacturing operations to ensure continuity of supply while adhering to global regulations and standards. This role is based on-site at our RTP (Research Triangle Park) Headquarters in NC and reports to an Associate Director, MSAT.

Job Responsibilities

• Collaborate with cross-functional teams to transfer small-scale gene therapy processes from Process Development into the MSAT laboratory and subsequently perform scale-up and transfer to the cGMP manufacturing scale
• Design, execute, analyze and interpret process characterization experiments to generate robustness data and define the process control strategy for PPQ manufacturing campaigns
• Develop small-scale models that are predictive of the cGMP manufacturing scale
• Author technical protocols and reports to support experimental work and maintain clear, organized electronic laboratory notebooks
• Provide effective communication of experimental results in technical presentations with internal and external stakeholders
• Lead cross-functional investigations by contributing technical expertise to the root-cause analysis and using a data-driven approach for driving issue resolution
• Ensure the laboratory is clean, organized and maintained in an efficient working order, securing supplies and materials for experiments, and proper scheduling of laboratory work

Minimum Requirements

• Bachelor's Degree in a scientific discipline with 5+ years of relevant work experience in the biopharmaceutical industry OR Master's Degree in a scientific discipline with 3+ years of relevant work experience in the biopharmaceutical industry
• Hands-on upstream and/or downstream biomanufacturing laboratory experience
• Excellent written and verbal communication skills, with experience interacting with a range of internal and external stakeholder groups
• Proficiency in using Microsoft Office Suite (Word, Excel, PowerPoint)
• Highly motivated, organized, and disciplined, with a strong desire to contribute as part of a best-in-class, collaborative tech transfer team
• Adaptable and eager to learn, thriving in a fast-paced, highly interactive environment
• Genuinely interested in building proficiency in upstream and downstream biomanufacturing operations, including process scale-up, technology transfer, process characterization, and process control strategy development
• Continuous improvement-oriented, seeking opportunities to optimize process operations and performance through proactive problem solving
• Open to domestic and international travel up to approximately 10%, as needed

Preferred Education, Experience and Skills

• Prior upstream experience
• Prior experience supporting cGMP manufacturing operations, process characterization, and/or PPQ activities
• Knowledge of the Design of experiment (DOE) methodology with an ability to design, execute, and analyze experiments with minimal oversight
• JMP Statistical Software proficiency is highly preferred