Director Of Process Engineering

Director of Process Engineering

List Biotherapeutics intends to be the market leader and premier CDMO to bring Live Biotherapeutics to market as we harness bacterial science to make the biggest impact possible and to help our customers create a healthier world.

We are seeking anexperiencedindividual to serve as Director level in Process Engineering.This role is part of the project team for a new company implementing a greenfield site to construct a bulk biological drug substance manufacturing plant intended for phase 3 and commercial level of live biotherapeutic products (LBP).The position requires seasoned experience supporting at-scale manufacturing processes (upstream and downstream) and technology transfer for microbial based systems.

This role is critical to successful execution of the project with solid leadership skills and ability for a forward-thinking. This role requires in-depth knowledge for microbial manufacturing processes and job skills based on the good understanding of regulatory compliance requirements, or any other manufacturing plant-based work.

Primary activities

• Provide input and review for development of URS for process equipment.
• Lead or participate the strategy development for process qualification and execution.
• Closely work with development group for technology transfer and scale up of customer products.
• Lead and collaborate to develop and buildprocess understanding and expertise for microbial based fermentation and the relevant downstream steps.
• As technical subject matter expert,interface with external clients for manufacturing projects.
• Develop initial stage of process and production control strategy over basis and detail design of facility and continue to update the strategy in preparation of regulatory approval and routine operations.
• Closely collaborate in evaluation for design of production equipment, performing technical review, participating vendor selection, and oversight of installation and qualification (FAT, SAT).
• Lead to develop strategy for bioburden control and implement the procedures in collaboration with external partners.
• Directly and indirectly work with internal and external stakeholders to lead technical discussionin designing and developing of manufacturing area and process trains for new site.
• Lead trouble-shooting of all manufacturing matters.

·Lead the department in the improvement of practices and procedures related to product and process quality, cost, and schedule adherence.

• Proactively analyze project risk and take prevent measures for prevention or resolution.
• Reporting to project lead, ensure close collaboration and suitable coordination of project activities across various stakeholders and parties
• Build basic document management system to support Good Engineering Practices at beginning and to be eventually evolved to GMP level.

Skill

• Strong demonstrated interpersonal, communication, negotiation, and persuasion skills.
• Teamwork in a diverse, collaborative, collegial culture
• Must have experience for supervision or management of production team to support routine commercial operations.
• BS in Biotechnology areawith 12 years’ experience in the biological manufacturing industry, particularly in process of microbial fermentation, recovery and purification.
• Eager to build from scratch with entrepreneurial spirit.
• Excellent in time management and problem solving.
• Working knowledge of manufacturing and design control principles and practices in the biopharma industry.
• Ability to build a culture of continuous improvement and model lean leadership principles
• Must be conversant with US FDA requirements governingmanufacturing operations for biological drug substance.
• Must have significant experience in process development, technology transfer or large-scale manufacturing process including fermentation, centrifugation, filtration, and lyophilization for biological drug substances.

• Biotechnology

Full-time