Job Details

Job Description

One of our large pharmaceutical clients is actively hiring for a Technical Transfer Lead, specializing in drug product sterile filling, supporting the external manufacturing team. This person will support tech transfers for vaccine and biologic drug products, specifically a liquid drug product tech transfer, with travel required three weeks per month onsite at the CMO on the west coast. The travel will start in September / October; until then, the role is remote.

The candidate will support sterile drug product technical transfers by authoring technical documentation and facilitating development studies through protocol creation, execution, sample submission, data analysis, and reporting. Support may also be needed for routine commercial drug production activities such as change controls and data analysis. Responsibilities include taking process designs, authoring protocols, executing studies (e.g., mixing, fill line, engineering batches), and being hands-on with manufacturing and sample submission. Data analysis and report authoring will also be required. The role involves working with Microsoft Office and JMP for statistical analysis and participating in the transfer of sterile drug products for commercialization, including manufacturing at larger scales, stability testing, and final container transfer under aseptic conditions.

Qualifications

• 4+ years' experience leading drug product technical transfers
• B.A./B.S. in Mechanical Engineering, Biomedical Engineering, Industrial and Systems Engineering, or related fields
• Experience in sterile drug product technical transfers, with a strong preference for sterile filling (Aseptic)
• Involvement in sterile manufacturing processes
• Technical writing and change control experience

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Contract
• Job function: Engineering and Administrative
• Industry: Pharmaceutical Manufacturing