Intern, Process Development

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.

JOB SUMMARY

We have an opportunity for an Intern to join AGC Biologics. This position requires technical problem-solving and inter-departmental collaboration and will be responsible for assisting with the transfer and implementation of new technologies and systems to support GMP operations.

ESSENTIAL JOB DUTIES/RESPONSIBILITIES

• Lead special projects as assigned focused on improved technology manufacturing reliability documentation workflows and/or data analysis.

• Support Staff Scientists/Engineers on project teams as needed to deliver on implementation of new equipment and technologies.

• Actively support process optimization and implementation of strategies for improving Upstream/Downstream unit operations throughout the product lifecycle.

• Monitor ongoing processing leading troubleshooting efforts as required collection and analysis of run data.

• Network with various departments as required to ensure project deliverables meet the needs of all stakeholders across the organization.

• Participate in the review and analysis of manufacturing campaign data trending and present daily progress as well as end-of-campaign summary updates.

• Support emergent events response for on-floor manufacturing issues.

• Generate and maintain documents related to GMP Manufacturing executions product impact assessments and campaign summary reports.

• Participate in the project team meetings decisions and creation of milestones representing your assigned department.

• May prepare and present data associated with manufacturing processes to internal and external clients.

SKILLS

• Working knowledge of biologics manufacturing unit operations such as Cell Culture Fermentation Viral Inactivation Chromatography Viral Filtration and Tangential Flow Filtration.

• Working knowledge of current Good Manufacturing Practices (cGMPs).

• Conceptual understanding of single-use technologies and aseptic processing.

• Understanding of Equipment onboarding and Life Cycle Management in a GMP setting is a plus.

• 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 Business Development etc.) to support processes and products.

• Demonstrated experience leading troubleshooting efforts.

QUALIFICATIONS

Required:

• Actively working towards a degree in a related engineering and/or scientific discipline.

• Completed a minimum of 2 years of undergraduate coursework.

• Concurrent coursework in related areas such as process control microbiology biochemistry bioprocess design bioreactors/bioseparations statistical data analysis etc.

• Fundamental understanding of Good Manufacturing Practices (GMP) and applicable regulations (e.g. ICH Q7A 21 CFR Part 211 etc.).

• Must have strong technical writing and data presentation skills.

COMPENSATION

$27 an hour

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 2500 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.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.