Job Description:

• 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.

Job Requirements:

Education

• 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.

Experience

• 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.