Principal Bioprocess Engineer - 19917

Principal Bioprocess Engineer- Simply Biotech

OVERVIEW

Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.

Immediate opening for a Principal Bioprocess Engineer with a biopharmaceutical company in San Diego, CA who possesses:

• Ph.D. with 6+ years of industry experience within bioprocess development
• Extensive experience with cell culturing tech transfers at a pilot scale
• Extensive experience with cell culturing/fermentation scale up to at least the 1,000 L scale

Email resumes to odrow@simplybiotech.com or call 858.866.8676

FULL DESCRIPTION: The core responsibility of this position is to set technical direction and manage execution of Pilotscale cell-culture process development and further scale-up efforts towards manufacturing. This role will focus on understanding the key technologies, raw materials, and process needs to effectively scale the bioprocess towards manufacturing. Candidates must be highly skilled in Pilotscale, bioreactor operation, process scale-up strategies and design of experiments, statistical analysis, and communication of results. This position will require significant subject matter expertise and hands-on laboratory work and the ability to lead team members and coordinate with external suppliers. This position reports directly to the Director, Bioprocess Development.

The selected candidate will be responsible for:

• Lead execution of development and optimization of pilot-scale cell culture.
• Design and implement cell culture scale-up strategies, spanning from pilot-scale working when required, with external service providers (such as CROs or CDMOs), to achieve critical company goals and technological benchmarks. This would include leading small and effective teams on critical process development and technology transfer projects with internal and external teams and when required, perform on-site visits with external collaborators.
• Work cross-functionally with R&D, Engineering, Quality, and Operations to successfully transfer SOPs and related documents that meet target specifications.
• Evaluate new and existing bioprocess technologies, methods, and equipment wit emphasis on scale-up and optimization of cell culture, media preparation and cell recovery.
• Serve as technical lead in discussions with service providers on conceptualization, design and construction of large-scale bioreactors and other upstream process equipment.
• Develop specifications, procedures, and testing protocols as required for bioprocess development and validation and assist in their execution.
• Facilitate industrial scale milestones that resonate with the quality standards set by the leadership and advocate for process enhancements at industrial collaborators aligning with functionality goals and overarching objectives.
• Preparation of invention disclosures and other IP documentation as required.
• Collaborate, when required, with suppliers and vendors to effectively source materials and services.
• Some weekend work may be required.

The selected candidate will also possess:

• A history of innovation, creativity, and collaborations with mammalian cell culture and/or food fermentations.
• Hands-on experience and mechanical aptitude for troubleshooting and maintaining bioreactor hardware and SCADA systems including defining and understanding automation requirements to work closely with team members and service providers to design, implement and update automation code in bioprocess equipment.
• Experience working in a GMP environment (and related processes and documentation) is preferred.

Salary Range: $150k-170k/yr
For immediate and confidential consideration, please email your resume to odrow@simplybiotech.com or call 858.866.8676. More information can be found at www.simplybiotech.com