Sr. Engineer, MSAT Downstream

Avid Bioservices • Tustin, CA

4d • $97,000 - $124,000

About The Position

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: Join our dynamic team as a Sr. Engineer , MSAT Downstream where you'll play a pivotal role in transforming and implementing cutting-edge Downstream processes within our Manufacturing division. As the linchpin for both clients and internal teams, you'll provide unparalleled technical support, leveraging your robust leadership abilities and deep knowledge of scaling processes, Downstream manufacturing equipment, and aseptic techniques. You won't just be setting the stage for operational success; you'll be actively mentoring other Downstream Engineers, leading technical project discussions with confidence and autonomy. In this role, you'll also spearhead process enhancements, optimizing efficiency and minimizing risk, propelling our operations to new heights of excellence. Be a part of a team where your expertise is not just valued, it's instrumental. Develop and maintain positive relationships with clients and internal teams (PD, MFG, QA, Validations, IT, Computerized Systems/Automation, etc.). Independently oversee projects from start to finish as the technical Subject Matter Expert (SME) with minimal supervision. Mentor MSAT Downstream Engineers/Associate Engineers using strong leadership skills. Communicate with clients about process status and collaborate to resolve on-floor issues. Lead process tech transfers, troubleshoot issues, and implement process improvements with technical expertise. Author Manufacturing Batch Production Records, Technical Reports, SOPs, User Requirement Specifications, Design Specifications, and Process Validation Protocols. Conduct scale-up assessments and equipment/facility fit and gap analyses for new or modified processes. Develop New Product Introduction protocols and Technical Risk Assessments, focusing on process monitoring and improvement. Provide technical training to Manufacturing Downstream Operators. Assist in CAPA investigations and recommend dispositions. Author or review Change Control projects and oversee their implementation. Conduct systematic investigations of root causes, problems, or identified risks. Research and identify new materials and/or equipment for continuous improvement. Evaluate the impacts of process, material, and equipment changes on product quality. Prepare and report analyses of proposed changes based on sound scientific and engineering principles. Perform statistical analysis of data for conclusions and recommendations. Other duties may be assigned.

Requirements

• B.S./M.S. in scientific or engineering (chemical or biomedical) discipline
• 4+ years in Downstream biologic manufacturing or process development, or at least 2 years in Downstream MSAT.
• Experience in quality assurance is highly beneficial.
• Extensive knowledge and hands-on experience in depth filtration, affinity purification, ion exchange, hydrophobic interaction chromatography, viral inactivation and filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills.
• Proficiency in operating downstream process equipment, including AKTA ready column chromatography skids, large-scale filtration skids, and Unicorn software.
• Proven ability to analyze and solve complex manufacturing and production issues using scientific principles.
• Experienced in technical transfer, scale-up, and mass transfer of Downstream processes.
• Skilled in generating and reviewing batch production records, technical risk assessments, and technical protocols/studies.
• Customer service experience, demonstrated through escorting persons in plant (PIP) or previous work roles.
• Solid understanding of cGMPs or equivalent regulatory standards.
• Strong decision-making skills for resolving or escalating production floor deviations and issues.
• Excellent communication skills, both written and verbal.
• Proficiency in time management, multitasking, and project oversight.
• Demonstrated leadership abilities.

Nice To Haves

• Familiarity with JMP statistical software is preferred.

Responsibilities

• Develop and maintain positive relationships with clients and internal teams (PD, MFG, QA, Validations, IT, Computerized Systems/Automation, etc.).
• Independently oversee projects from start to finish as the technical Subject Matter Expert (SME) with minimal supervision.
• Mentor MSAT Downstream Engineers/Associate Engineers using strong leadership skills.
• Communicate with clients about process status and collaborate to resolve on-floor issues.
• Lead process tech transfers, troubleshoot issues, and implement process improvements with technical expertise.
• Author Manufacturing Batch Production Records, Technical Reports, SOPs, User Requirement Specifications, Design Specifications, and Process Validation Protocols.
• Conduct scale-up assessments and equipment/facility fit and gap analyses for new or modified processes.
• Develop New Product Introduction protocols and Technical Risk Assessments, focusing on process monitoring and improvement.
• Provide technical training to Manufacturing Downstream Operators.
• Assist in CAPA investigations and recommend dispositions.
• Author or review Change Control projects and oversee their implementation.
• Conduct systematic investigations of root causes, problems, or identified risks.
• Research and identify new materials and/or equipment for continuous improvement.
• Evaluate the impacts of process, material, and equipment changes on product quality.
• Prepare and report analyses of proposed changes based on sound scientific and engineering principles.
• Perform statistical analysis of data for conclusions and recommendations.
• Other duties may be assigned.

Benefits

• We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
• Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level