Job Description
Our client is a major multinational pharmaceutical manufacturer based in Dublin now have a permanent role for an API Manager, Process Manufacturing.
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.
Ideal candidate will have technical expertise in the areas of API, Intermediate and Starting Material production, Drug Product, Sterile Manufacturing, Packaging and Medical Devices for products manufactured in an external manufacturing environment.
Job Spec:
The API Manager role requires demonstrated significant experience of manufacturing processes relating to the manufacture of small molecule API and corresponding intermediate materials.
Responsibilities of API Process Manager:
? 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.
Requirements for API Process Manager:
? BSc in Chemistry or Chemical Engineering or Process Engineering. Ideally PhD in Organic Chemistry.
? 7+ relevant industrial experiences.
? Demonstrated project management and technical leadership capability.
? Subject Matter Expert in relevant API chemistry, process development, process management and trouble shooting, process robustness improvement.
? In-depth knowledge of pharmaceutical process scale-up, tech transfer and manufacturing support (change control, investigations, process optimisation). 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.
? Thorough knowledge and understanding of Regulatory requirements (cGMP, filing, EHS).
? 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 01-2302400 / larry@rftgroup.ie
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
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