MS&T Senior Engineer

Medicago: A history of innovation and perseverance

We started our journey with one objective: to help protect human life and today, we are a global leader in developing and producing plant-based vaccines and therapeutics.

Your role: 

Under the supervision of the Principal Engineer Formulation and Filling of Manufacturing Science and Technology, the incumbent will be involved in the industrialization and optimization of the formulation and filling of vaccine candidates as well as the technical transfer to CMOs. The incumbent will also participate and assist the Principal Engineer in technical investigation on drug product manufacturing and stage 3 validation of the drug product processes.

What your days would look like: 

• Act as SME for formulation and filling activities
• Contribute to design and execution of process troubleshooting, scale-up, and optimization experiments using small-scale production and lab processes. Working in collaboration with SMEs from R&D, Quality, Operations, Validation and external partner to support technology transfer of drug product processes to external manufacturing sites and product licensure
• Interface extensively in a matrixed environment with process and analytical development teams for process investigation support, assess new analytical technologies, support on-going process characterization and post-approval changes
• Author technical documents for development, manufacturing, validation, technology transfer, and process optimization/improvement activities
• Work with CMOs and data scientists to collect, analyze, and report data to support process monitoring and trending activities, including trend analysis, to assess process performance and ensure a state of process control
• Use scientific and statistical knowledge to analyze data to identify root causes of production and process events, support development and CMO manufacturing, and drive continuous improvement activities
• Perform technology transfer activities including coordination and review of process information and documentation from development and CMO manufacturing groups (protocols, reports, batch records and standard operating procedures)
• Contribute to validation, annual product review, and product quality review activities
• Assist with regulatory submission as needed; support investigation as needed
• Serve as Manufacturing / Technical point of contact on specific workstreams/sub-projects, attending teleconferences with CMOs and internal teams

Required profile: 

• Degree in an engineering or scientific discipline with experience in biopharmaceutical Manufacturing Science & Technology / Manufacturing / Process Engineering
• B.S. with 7 years of industrial experience
• Prior experience in Protein Drug Product industrial formulation 
• Strong knowledge of biologics drug product manufacturing operations and equipment (sterile filtration, formulation, sterile filling), with prior experience in Manufacturing, Technical Operations or manufacturing Science and Technology
• Experience with regulatory filings and submissions
• Effective communication skills and the ability to write detailed technical reports
• Strong French communication skills; functional English communication skills

Medicago is changing the game!

Our Vision: Medicago envisions a world that is prepared to face any disease

Our Mission: To create and deliver effective responses to new global health challenges.

Our mission is driven by the values of innovation, integrity, collaboration, adaptability, and ownership. These values reflect the spirit and culture that inspire Medicago’s people.

As a pioneer in transient expression and plant-based manufacturing, Medicago has always sought a more effective way to improve human health. With nearly 20 years of experience and wisdom behind us, we are poised to revolutionize the traditional approach to vaccines and therapeutics.

It is important that you are legally entitled to work in the US or Canada at the time the job offer is made to you. You may be asked to provide proof of eligibility.

#LI-IB1

#indhi