Title: Biochemical Process Engineer

Job Summary

Oversee the product of the device chemistry and spraying groups and ensure the process is being run according to the batch records and also expected to provide insights for process improvements activities as mandated by cGMP’s policies/procedures and Frontida’s quality standards. Assist operations and quality units as necessary.  Train operators as necessary

Responsibilities

Review protocols, manufacturing and validation batch records, ensure sampling and testing are completed as planned, executing manufacturing batch records and evaluate all in-process and analytical data.

Coordinate cleaning and manufacturing activities with the device chemistry and spraying groups and the Quality Unit.

Planning and managing the scheduling for the device chemistry and spraying groups to meet planned goals.

Coordinate and execute the manufacturing of batches associated with the device chemistry and spraying groups to ensure a quality and robust product.

Generate/review, as necessary, all pertinent documentation, procedures, batch history, and reports prior required.

Troubleshoot and provide assistance for Biodot Equipment as well as any problems that arise during the overall process.

Develop interdepartmental project plans, proactively identify resource and quality issues, facilitate communication across all functions that impact the timeline and assist management with potential problem analysis and solutions.

Work with the R&D Tech Transfer and Validation on the process improvements and validation activities.

As well as ensure that inventory of materials is accurate and being properly documented by working with the inventory team. Ensure daily use lab supplies are reordered on time as well.

Perform other duties as assigned

Qualifications

Master’s Degree (or higher) in Chemistry, Chemical Engineering, Biochemical Engineering, Biochemistry. Bachelor’s Degree will be considered with related experience

Knowledge and Skills

  • A minimum of 5 Years of cGMP Experience
  • Pharmaceutical Diagnostics and/or Biotechnology Experience
  • Understanding of Lateral Flow Assay Development
  • Familiarity with Immunochromatographic Assays
  • Supervisorial Experience, Equipment understanding is helpful, but not required
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