Our client, a drug development company in biologics, now seeks a Project Manager to provide technical oversight on manufacturing processes for an externally manufactured product, ensuring drug development is on track and executed to client companies requirements to meet NDA filing.
The successful candidate will provide process management oversight of all aspects of scale-up during drug development process to commercial manufacturing, including; development processes, validation, execution and documentation.
This role requires proven technical competence, soft-skills and project management / reporting duties, working with a number of stakeholders throughout project lifecycle.
Note: This project will require the incumbent to work in Germany for 6 month period and then work in Dublin for a further 6 months, with some intermittent travel to Europe.
Responsibilities of Project Manager, Drug Development:
- Oversight of technical transfers to contract manufacturing organizations. This includes Technical Transfers of products from Development, internal sites and from CMO to CMO.
- Oversight of process capability analysis to assess process robustness. Identifying and executing process robustness improvement projects, where required.
- Supporting CMO/vendor selection – preparation of technical information packages, participation in due diligence and site assessments, technical evaluation of RFIs and RFPs.
- Providing technical guidance in the understanding of root causes for out of trend or out of specification results or deviations for manufacturing processes.
- Driving the use of strategies, resources and processes (OPEX etc.) to improve processing efficiency and to ensure optimised technical support for manufacturing, technical transfer and scale-up of processes to commercial scale.
- Provide technical expertise for change management, investigation CAPA identification and related activities at contractor.
- Bachelor’s Degree Process Engineering, Chemical Engineering or BSc in Chemistry or similar discipline. Ideally Masters or PhD qualification.
- Experience as the technical lead on new product development, scale-up, technical transfer projects into commercial manufacturing cGMP.
- Subject Matter Expert in process development, process management and troubleshooting, process robustness improvement through to commercial manufacture cGMP.
- Demonstrated capability in the use of standard tools for root cause analysis.
- Confident management of internal and external stakeholder relationships.
- Strong communication and negotiation and influencing skills are required.
- Experience in regulatory filings, e.g. NDA filing and associated documentation requirements to FDA regulations.
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie