Senior BioProcess Engineer

Austin, TX Bioprocess Technical Operations / On-site

The Company

MaverickX is revitalizing critical resource extraction with precision biologics. We are a team of scientists, engineers, and business operators who are bringing cutting-edge biotechnology products to the world’s most critical industries.

The Role

The Senior BioProcess Engineer will be a member of BioProcess Technical Operations team at MaverickX. This position will be responsible for the technical hands-on oversight of product development activities associated with process development including fermentation, downstream processing, analytical methods development, and scaling up bench scale processes to pilot scale production for field trials, as well as assist with commercial manufacturing. The BioProcess team will be responsible for pilot scale production runs for feasibility field trials to be conducted by MaverickX customers or partners, and technology transfer to commercial manufacturing site(s) to support customers or partners commercial application requirements. This job includes the buildout and management of a new Pilot-scale manufacturing facility at Pleasanton, TX (near San Antonio, TX) or near Austin, TX R&D/ Headquarters facility, and also assist in planning for commercial scale manufacturing facility.

Responsibilities

• Lead in-house process development, assist with the design and procurement/ assembly of pilot-scale (100-1000L) fermentation equipment and development of the production process for the manufacturing of material for initial feasibility field trials.
• Assist with the selection of equipment and design of the intermediate scale (5-10KL) facility for the supply of material for field trials.
• Assist with the selection of equipment and design of the commercial scale (10-50KL) facility for the commercial manufacturing of material to support various applications.
• Collaborate closely with discovery research team for the process development of unique/diverse microorganisms producing novel products for new applications.
• Lead troubleshooting and root cause analysis of upstream and downstream process challenges and implement effective process improvements.
• Knowledge of data analysis software for upstream and downstream process data.
• Experience with deviation investigations, CAPA, and change control.
• Lead/ represent cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives.
• Help to build out high performing team and provide innovative strategies to maximize team engagement and ensure team reaches full potential to deliver products in a timely fashion.
• Collaborate with Quality Department to ensure rigorous safety and quality requirements are met for both local and national regulatory agencies.

Qualifications

PhD degree with 4-6 years of Biologics Process Development, Engineering or Manufacturing experience (OR) MS degree with 6+ years experience in Biotechnology/Biopharmaceutical process development or pilot-scale/commercial manufacturing. Supervisory experience managing small teams or leading projects/programs within Process Development and Manufacturing teams. Strong interpersonal verbal & written communication skills; ability to work independently; supervise/mentor junior team members. Experience preparing SOPs & Production Batch Records documentation. Innovative strategies to maximize team engagement & ensure timely delivery of products. Collaborate cross-functionally including discovery research & Quality Department teams. Knowledge & hands-on experience in fermentation & downstream processing techniques. Analytical methods development & scaling up bench scale processes to pilot scale production. Troubleshooting & root cause analysis skills related to upstream/downstream processes. Experience using data analysis software related to bioprocess data compilation & interpretation. Experience conducting deviation investigations including CAPA & change control procedures. Technology transfer knowledge from pilot scale to commercial manufacturing sites.