Process Engineer MS&T -Drug Product

Duties and Responsibilities

• Responsible for end-to-end technical support of gene therapy product manufacturing (Drug Product Fill Finish), at CMOs.
• Works cross functionally with Process Development, CMO, Quality Assurance, Quality Control, Supply Chain, and Validation departments to effectively transfer, implement and maintain processes at multiple facilities.
• Works closely with the CMO to provide on-the-floor technical oversight through each product campaign startup as well as in response to any process/equipment troubleshooting requirements related to DP Fill Finish.
• Collects and trends process data, performs process capability assessments, and identifies areas for continuous improvement related to DP Fill Finish.
• Authors and/or reviews technical reports, process tech transfer summary reports, risk assessments, master batch records, equipment user requirement specifications, and protocols in support of tech transfer, cGMP activities and regulatory filings.
• Provides technical support for investigations and lends expertise in problem solving activities on existing production activities, determining root cause and corrective actions.
• Leads/supports process improvement projects, including new technologies for DP Fill Finish.
• Offers subject matter expertise as a reviewer of project plans, technical reports/studies related to process understanding, regulatory submissions, and Validation protocols at CMO for DP Fill Finish.

Education and Experience

• B.Sc or M.Sc in Chemical Engineering, Bioengineering, Biotechnology or another relevant engineering / scientific qualification.
• Level will be determined based on education and experience.
• 3-4 years of experience in a biopharmaceutical manufacturing setting where the individual has implemented process changes/optimization, technology transfer, and manufacturing support.
• Experience in process development and/or process scale-up studies of Drug Product Fill Finish operations is a plus.
• Experience summarizing and presenting data, statistical analysis, and authoring technical reports.
• Strong computer skills with Microsoft Office, data trending/management software (Excel and Jmp), and the ability to quickly learn new applications.

Desired Key Competencies

• Strong technical and scientific knowledge of drug product manufacturing operations.
• Experience with manufacture of viral vectors and/or viral vaccines is a plus.
• Critical thinking and strong problem-solving skills with quantitative and analytical mind-set.
• Self-organizer, meticulous hands-on habits, keen attention to detail.
• Perform other responsibilities to support the needs of the department, as assigned.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Experience with JMP statistical software.
• Knowledge and experience in Operational Excellence (OE) methodologies is a plus.
• Maintains a high degree of ethical standard and trustworthiness.
• Exhibits and open mindset when approaching challenges and conflict.
• Demonstrates the ability to mentor and coach team members in all areas of expertise.