API Manufacturing Process Specialist
Our client is a major multinational pharmaceutical manufacturer based in Dublin now have a permanent role for an API Specialist.
This permanent role will provide technical support on manufacturing processes relating to Manufacture and oversight for a portfolio of these externally manufactured products, ensuring consistent security of supply across CMOs in Europe.
Scope of API Manufacturing Process Specialist:
The API Specialist role requires demonstrated significant experience of manufacturing processes relating to the manufacture of small molecule API and corresponding intermediate materials.
Key responsibilities include:
- Provision of ongoing technical support and oversight for a portfolio of externally manufactured APIs, Intermediates and Starting Materials, ensuring consistent security of supply.
- Driving process capability analysis to assess process robustness. Identifying and executing process robustness improvement projects, where required. Using this information and knowledge to contribute to comprehensive and accurate annual product and annual contractor reviews.
- Supporting CMO/vendor selection ? preparation of technical information packages, participation in due diligence and site assessments, technical evaluation of RFIs and RFPs.
- Managing technical transfers to contract manufacturing organizations.
- Technical oversight and direction for process validation
- Providing technical guidance in the understanding of root causes for out of trend or out of specification results or deviations for API or intermediate 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 support for change management, investigation CAPA identification and related activities at contractor site.
BEng in Chemical or Process Engineering, BSc in Chemistry or similar. Ideally PhD in Organic Chemistry.
3+ relevant industrial experience.
Demonstrated project management and technical leadership capability.
Subject Matter Expert in relevant API chemistry, process development, process management and trouble shooting, process robustness improvement.
Understanding of process, engineering, analytical and regulatory aspects.
Hands-on process management experience of all aspects of small molecule API commercial manufacturing processes
Understanding of statistical process analysis and control methods. Experience in using Statistical software packages.
Confident management of internal and external stakeholder relationships
Strong communication and negotiation skills are required for this position as well as the ability to translate technical issues into business impact and relevant solutions.
Experience as the technical lead on API Technical Transfer projects.
Please phone Larry on +353 1-2302400 / firstname.lastname@example.org
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