Process Engineer: Scale-Up & GMP Manufacturing

Socket.dev; Comfrey (MN); On-site; USD 80,000 - 92,000; Full time

Job summary

Lifecore Biomedical, LLC. in Minnesota is hiring a Process Engineer to participate in the development of manufacturing processes from benchtop to commercial scale.

You will support transfer of benchtop scale processes, assist scale-up to pilot and commercial production, and perform pre-GMP and GMP batches for clinical projects. Strong data analysis and DOE experience are valued.

Excellent hands-on lab skills and ability to communicate with clients and internal teams are essential.

Qualifications

• BS in Chemistry, Biochemistry, or Chemical Engineering.
• 2-5 years biotechnology or pharmaceutical related process development and/or manufacturing experience.
• Experience in the processes or methods used in the biotechnology or pharmaceutical industry.
• FDA regulated industry experience.

Responsibilities

• Support transfer of benchtop scale processes from customer sites to Lifecore.
• Support scale up of benchtop processes to pilot and commercial scale.
• Manufacturing pre-GMP and GMP batches for clinical phase projects.
• Communicate critical project information to clients and internal project team members through meetings and written correspondence.
• Evaluate manufacturing process design and performance using design of experiments (DOE) and statistical analysis.
• Lead analysis of process improvements to commercial products.
• Perform critical analysis of data using detailed observations and independent interpretation of results.

Skills

Lab skills

Process development

FDA compliance

Education

BS in Chemistry/Biochemistry/Engineering

Job description

Lifecore Biomedical, LLC. in Minnesota is hiring a Process Engineer to participate in the development of manufacturing processes from benchtop to commercial scale.

You will support transfer of benchtop scale processes, assist scale-up to pilot and commercial production, and perform pre-GMP and GMP batches for clinical projects. Strong data analysis and DOE experience are valued.

Excellent hands-on lab skills and ability to communicate with clients and internal teams are essential.