MSAT Engineer III

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

PRINCIPAL RESPONSIBILITIES:

• Serve as MSAT representative on client project teams.
• Actively support/lead process optimization and implementation of strategies for improving Upstream unit operations throughout the product lifecycle.
• Support/Lead resolution of deviations, investigations, and process issues.
• Network with Process Development, Manufacturing, and Quality team members to ensure reliable state to process control and drive continuous improvements.
• Participate/lead in review and analysis of manufacturing campaign data trending, and present daily progress, as well as end of campaign summary updates.
• Support/ lead emergent events response for on-floor manufacturing issues.
• Generate and maintain documents related to GMP Manufacturing executions, product impact assessments, and campaign summary reports.
• Define and provide user requirements for process equipment associated with multiple facilities for the manufacture of biologic Bulk Drug Substance(s).
• Provide technical leadership to Manufacturing and other departments associated with GMP operations.
• Serve as the process Subject Matter Expert; provide input when troubleshooting processes on the manufacturing floor and during post-operational investigations
• Participate in the project team meetings, decisions, and creation of milestones representing MSAT.
• Prepare and present data associated with manufacturing processes to internal and external clients.
• Maintenance of Process Control Strategy
• Process training, as needed, in adherence to company policies and quality requirements.

KNOWLEDGE, SKILLS & ABILITIES:

• Working knowledge of Upstream unit operations.
• Well-experienced with operations of single-use technologies and aseptic processing.
• Must be self-motivated, organized and proactive.
• Demonstrated ability to interface/communicate extensively with internal and external clients.
• Ability to coordinate multi-departmental tasks and deliverables (interaction with Manufacturing, Process Development, Engineering, QA, QC, etc.).
• Proven experience successfully managing multiple projects simultaneously.
• Demonstrated ability to build effective working relationships across departments (Manufacturing, QA, Process Development, Project Management and Business Development) to support processes and products.
• Demonstrated experience leading troubleshooting efforts.
• Ability to provide technical training to others on GMP manufacturing operations.
• Strong communication skills necessary to interact with internal stakeholders.
• Strong presentation skills.

EDUCATION/EXPERIENCE:

• Degree in an Engineering or Science-related field with minimum of 2 years working with biotechnology cell culture experience, preferably in clinical/commercial GMP manufacturing.
• Minimum of 2 years of experience bringing biotechnology equipment and processes from design through GMP operational readiness.
• Must have experience with and demonstrated understanding of Good Manufacturing Practices (GMP) and applicable regulations (e.g., ICH Q7A, 21 CFR Part 211, etc.).
• Must have experience writing, reviewing and approving GMP documentation.

COMPENSATION:

$83,920 - $115,930

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. 

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.