MSAT Engineer I/II

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.

We have an opportunity for an MSAT Engineer I/II to join the Manufacturing Science and Technology (MSAT) team at AGC Biologics in Boulder, CO. This position requires technical problem-solving and inter-departmental collaboration. Responsibilities will be varied, requiring time management skills and ability to deliver against fluid timelines. This role is responsible for 24/7 production support when manufacturing operations are in progress including direct Person in Plant and customer support.  Other responsibilities include technology transfer support, new proposal support, quality systems support and data collection, trending, and analysis support.

PRINCIPAL RESPONSIBILITIES

• Serve as main MSAT production support when 24/7 production support when manufacturing operations are in progress including direct Person in Plant and customer support.
• Participate as an MSAT representative on client project teams and internal project teams.
• Provide subject matter expertise for deviations, investigations, and process issues and troubleshooting.
• Perform root cause investigation, Product Impact Assessments (PIA) and CAPA.
• Network with Engineering, Manufacturing, Quality and other site team members to drive continuous improvements and to ensure reliable process control.
• Participate in review and analysis of manufacturing campaign data trending.
• Participate as an MSAT representative during technology transfer of a new process or product.
• Participate as an MSAT representative and provide subject matter expertise during new proposal phase.
• Generate and maintain documents related to GMP production, including Master Production Records (MPR), sample plans, dispensing and kitting plans, and campaign summary reports.
• Prepare and present data associated with manufacturing processes to internal and external clients.
• Support department change record assessments.
• Support development of user requirements for process equipment associated with the manufacture of biologic Bulk Drug Substance(s).
• Support execution of Continuous Process Validation (CPV) plans for commercial products.
• Participate on site critical cross functional projects and teams in support of risk identification and mitigation and continuous improvement.
• Support cross functional teams for impact and criticality assessments surrounding alarms, components and instruments.
• Support for process validation preparation, execution, and reporting.
• Drafting and Maintenance of Process Overview Training content.

KNOWLEDGE, SKILLS & ABILITIES:

• Working knowledge of Downstream unit operations, including Chromatography, UF/DF, Single-Pass TFF, Depth Filtration, Viral Inactivation, Viral Filtration, column packing, depth filtration, formulation, and bulk fill.
• Must be self-motivated, organized and proactive.
• Ability to build effective working relationships across departments (Manufacturing, QA, Process Development, Project Management and Business Development) to support processes and products.
• Strong interpersonal and communication skills necessary to interact with internal and external stakeholders.
• Strong critical thinking, problem solving, decision-making and data analysis skills.

EDUCATION/EXPERIENCE:

• BS in Chemical engineering / Biochemical engineering / Biology or other science related discipline preferred.  Equivalent education and experience may substitute for stated requirements.
• Level I:  Entry level – 1 year of experience from the pharmaceutical industry or similar working in a cGMP environment.
• Level II:  2 or more years’ relevant experience from the pharmaceutical industry or similar working in a cGMP environment.
• Advantage with primary biotechnology recovery and purification experience, specifically in technology transfer/process development/manufacturing experience.
• Advantage with direct experience in CDMO environment.

COMPENSATION

MSAT Engineer I-$66,960 - $92,070

MSAT Engineer II- $74,960 - $103,070

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.