Bioprocessing Engineer II

4 weeks ago

Norwood Young America, Minnesota, United States Moderna Full time
Role Summary

The DNA and Chemistry Manufacturing Sciences & Technology (MS&T) team at Moderna is responsible for ensuring the robust technology transfer and technical support of our plasmid and custom nucleotide platforms in clinical and commercial drug substance cGMP manufacturing.

As a Bioprocessing Engineer II in MS&T, you will partner with stakeholders in Process Development, Manufacturing Operations, Regulatory and Quality to ensure all aspects of technology transfer and technical support are successfully executed.

You will provide engineering support for process equipment used at Moderna's Norwood cGMP manufacturing facilities.

Key Responsibilities
  • Follow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
  • Practice and promote safe work habits and adhere to safety procedures and guidelines.
  • Execute tasks precisely as defined in internal guiding documents, including standard operating procedures (SOPs) and work instructions.
  • Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
  • Utilize the manufacturing support systems and equipment as required, including SAP, VEEVA, Delta V, Syncade, LIMS, and CMMS.
  • Support technology transfer projects, including coordination of process information exchange, documentation of process parameters, and tracking process performance.
  • Independently provide basic technical support of cGMP manufacturing, including authoring of simple technology transfer documents, change control, manufacturing investigations, and helping validation activities.
  • Analyze manufacturing performance through data review and analyses. Establish and maintain data repositories.
  • Collaborate with process development on studies to determine root cause for basic deviations.
  • Lead a cross-functional team for moderately complex troubleshooting and operational improvements to manufacturing equipment.
  • Lead design and engineering of basic disposable systems used in bioprocessing, including aseptic bioprocessing bags and tubing manifolds. Execute basic studies to demonstrate equipment fit and process performance.
  • Author and execute protocols supporting process characterization and equipment scale up in cGMP Manufacturing.
Requirements
  • Bachelor's Degree in a STEM field or related field.
  • 3-5 years of industry experience or Master's Degree with 1-2 years of industry experience.
  • Working understanding of GMP regulations.
  • Process development or operational experience in bioprocessing unit operations, such as fermentation, enzymatic reaction, chromatography, or tangential flow filtration.
  • Knowledge of data management and statistical analysis.
  • Excellent judgment and ability to communicate manufacturing issues in a scientifically sound way.
  • Excellent communication skills, verbal and written.
  • Ability to manage projects and adapt in a fast-paced environment.
  • Ability to collaborate in a dynamic, cross-functional environment.
About Moderna

Moderna is a leading biotechnology company that is pioneering the use of mRNA technology to develop novel therapeutics and vaccines.

We are committed to advancing the field of mRNA technology and improving the lives of patients worldwide.

Our team is passionate about innovation and collaboration, and we are seeking talented individuals who share our vision and values.

Moderna is an equal opportunity employer and welcomes applications from diverse candidates.

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