MUST BE ON-SITE in ROCHESTER, MN - RELOCATION OFFERED
*Must be eligible to work in the US
Sr/Process Development Engineer/Scientist
About the Company:
This position is for an engineer/scientist focused on pharmaceutical/biologics manufacturing located in Minnesota. This position will support process development and early clinical manufacturing. This is a hands-on role to support both current and future development and manufacturing of cutting-edge biopharmaceutical products.
Must Have Late Stage/Commercial experience (they will be entering Phase 3 next year), Validation/Characterization
Nice to Have: Formulation and Fluid Mixing experience
No direct reports to start, may grow into a supervisor/manager later on
Lead for process and equipment validation activities for GMP manufacturing PPQ/pre-commercial activities.
Support process and new product development activities and transfer to the manufacturing area.
Troubleshoot manufacturing processes and propose solutions.
Identify opportunities to improve process efficiency and work with the development team to determine the best plan of actions for implementation.
Develop expertise in specific areas of manufacturing (SME).
Work with technical drawings, spec sheets, and requirements to complete tasks.
Construct and perform DOE studies and use CpK/PpK analysis to track process success.
Tech transfer of new and updated processes to CMOs including training of operators to new processes.
Executing batches following cGMP and GDP principles (as needed).
Writing and reviewing documents including necessary FDA compliant work instructions/batch records/forms/SOPs.
Routinely participating in new procedure planning and implementation into the manufacturing area.
Assist with performing routine maintenance of production equipment and production suites.
Deviation identification, support investigations and CAPA support.
Preferred requirements:
Master's degree or BS
10+ years of experience in a manufacturing/process development environment.
LEAN, Six-Sigma, or other efficiency program experience.
Experience manufacturing in a pharmaceutical environment.
Experience leading a team.
Direct Supervisor/Management experience a plus.
Experience with pharmaceutical product purification and single use systems.
Pay range and compensation package:
Pay range or salary or compensation
Equal Opportunity Statement:
Include a statement on commitment to diversity and inclusivity.