API Tech Transfer Manager, SME
|Job Title:||API Tech Transfer Manager, SME|
|Contact Name:||Larry O’Leary|
|Job Published:||10 months ago|
Our client is a major multinational pharmaceutical company based in Dublin now seek a Tech Transfer Manager / Subject Matter Expert with technical expertise in the areas of API, Intermediate and Starting Material production.
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 US and Europe.
Ideal candidate will have strong communication and negotiation skills, with proven ability to translate technical issues into business impact and relevant solutions.
The API Manager role requires demonstrated significant experience of manufacturing processes relating to the manufacture of small molecule API and corresponding intermediate materials.
Key responsibilities for API Tech Transfer Manager, SME:
- 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.
Person Spec for API Tech Transfer Manager, SME:
- BSc in Chemistry or Chemical Engineering or Process Engineering. Ideally PhD in Organic Chemistry.
- 8 plus years' relevant industrial experience.
- Demonstrated project management and technical leadership capability.
- Subject Matter Expert in relevant API chemistry, process development, process management and troubleshooting, 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
- Experience as the technical lead on API Technical Transfer projects
20% of international travel associated with this role.
Please contact; 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. https://www.rftgroup.ie/
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