Senior BioProcess Engineer

MaverickX • Austin, TX

13d • Onsite

About The Position

The Senior BioProcess Engineer will be a member of the 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.

Requirements

• PhD degree with 4-6 years of Biologics Process Development, Engineering or Manufacturing experience (OR)
• MS degree with 6-8 years of Biologics Process Development, Engineering or Manufacturing experience.
• In addition, 2+ years of supervisory experience, managing small teams and/or leadership experience leading teams, projects, programs or directing the allocation of resources within Process Development and Manufacturing teams.

Nice To Haves

• MS or PhD degree in Biochemistry, Microbiology, Biochemical or Chemical Engineering, or in a technological field.
• 10+ years of experience in Biotechnology/ Biopharmaceutical process development or pilot-scale/ commercial manufacturing.
• Demonstrated ability in providing engineering expertise to cross-functional teams, manufacturing, quality and supply chain to advance complex projects to completion and to interface on technical problem resolution.
• Strong background and understanding of microbial physiology/ fermentation, downstream processing, small-scale process development to scale-up for pilot-scale and commercial manufacturing.
• Manufacturing documentation (SOPs and Production Batch Records) preparation experience.
• Process data compilation and analysis, interpretation and experimental plans to support Project plans, and make presentations to cross-functional teams and senior management team.
• Strong interpersonal, verbal and written communication skills.
• Be a team player with strong analytical, and leadership skills.
• Be able to work independently and supervise/mentor junior team members.

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.

Benefits

• Premium health insurance: With medical, dental, and optical options, we offer some of the best coverage on the market
• Continuing education: We take employee development seriously and strive to unlock our team's full potential through continuous learning initiatives

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree