A Technical Transfer Specialist is required for a biopharmaceutical company in West Dublin. This position fosters effective cross-functional working relationships with internal and external groups in operations, process development, analytical sciences, and quality assurance for the technology transfer of new and existing products and providing support for regulatory submissions related to commercial and clinical products manufactured at CMOs.
- The successful candidate will be responsible for technical oversight at Contract Manufacturing Organizations (CMOs) used by our client to produce commercial and clinical Drug Product (Biologics and Oral Solid Dosage).
- This position provides strong scientific leadership for all aspects of technology transfer, validation, process scale-up, inspection, process monitoring, and process troubleshooting for manufacturing activities.
- There is strong emphasis on continuous process improvement with this role.
Providing technical and scientific direction for technology transfer and validation of Drug Product at CMOs.
- Lead troubleshooting and root cause analysis activities using best in class problem solving for critical issues at Drug Product CMOs.
- Ensure that all processes are appropriately validated and approved for manufacturing and partner with regulatory and quality assurance colleagues to ensure that processes are maintained in a validated and compliant state throughout their lifecycle.
- Provide guidance to process validation program for Drug Product manufacturing processes at CMOs.
- Provide technical input to process development for defining the critical process parameters of new processes.
- Oversee process monitoring and statistical analysis of commercial external manufacturing activities (continued process verification).
- Support the generation and review of CMC sections of the BLA and other technical documents for regulatory agency submission for commercial CMO sites.
- Provide significant technical depth to support continuous process improvement to maximize yield and lower cost of goods (CoGs).
- Provide technical direction for the identification and implementation of process optimization initiatives as well as efficiency and capacity improvements at CMOs.
- Communicate operational status of CMOs regularly to management, as required, at the appropriate level of detail.
- Communications will be both written documents, and in formal and informal oral presentations.
- Up to 20% international travel may be required.
Qualifications & Experience:
- Minimum undergraduate degree in a scientific discipline (Chemistry, Biochemistry, Pharmacy), Engineering (Chemical, Mechanical) or related field.
- An advanced degree (MS, PhD) is desirable.
- Minimum of 5 years’ experience in a technical or manufacturing role in the pharmaceutical industry with a major focus on Drug Product development and / or manufacturing.
- High level of technical expertise in pharmaceutical manufacturing across multiple technology and processing areas (oral solid dose, aseptic / parenteral filling).
- Comprehensive understanding of cGMP requirements for clinical and commercial manufacturing.
- Broad experience of technology transfer and process validation management and continuous improvement
- Strong communication skills enabling him/her to influence both internal and external partners.
- Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
- Lean six sigma experience is preferred.
- Knowledge of Quality by Design (QbD) principles, including the use of multivariate data analysis and/or first-principles process modeling in conjunction with predefined multivariate operating ranges (“Design Spaces”) in a commercial manufacturing setting.
- Knowledge of basic statistical principles and exposure to statistical software packages (e.g., Minitab, JMP).
- Exposure to/experience of Project Management principles and tools.
- Exposure to/experience of MS Project or other project management software.
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