Maintain an overview of fermentation process performance through data trending and front-line support of commercial manufacturing operations.
Use scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes are capable and operating in a state of control, and identify opportunities for process improvements.
Participate in product and process-related technical investigations and root-cause analyses of process deviations, complaints, and OOS/OOE events.
Work with cross-functional manufacturing and quality teams in the execution of technical protocols, development activities, and scale-up/technology transfer programs.
Develop/execute projects to address process issues and deliver on improvement opportunities.
Participate in resolution of technical and compliance issues, technical answers to QA, internal inspection bodies, and to Health Authorities.
Author of and assist in preparation and critical review of technical documents, APRs/RQRs, risk assessments, PFD's, batch records, SOPs, protocols, and reports.
Demonstrate strict adherence to cGMP standards and company policy and procedures.
Maintain a "Safety First, Quality Always" mindset.
Support other operational programs and initiatives as required.
MSc. in Engineering, Bio/Pharma Technology, Chemistry, Microbiology, or similar scientific degree desired.
Bachelor's level degree with equivalent work experience will also be considered.
Minimum of 3-5 years' experience in the pharma/biotech industry, with emphasis on the fermentation processes - cell and viral culture experience a plus.
Proven understanding of biopharmaceutical production processes.
Demonstrated knowledge and experience with operations in a commercial cGMP manufacturing facility.
Proven success in working within multi-disciplinary project teams with excellent communication, problem-solving, and critical-thinking skills.
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