What are the responsibilities and job description for the Senior Process Development Engineer/Scientist position at The Steely Group?
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.
Salary : $100,000 - $125,000
