Process Development Manager, API pharma
|Job Title:||Process Development Manager, API pharma|
|Contact Name:||Larry O’Leary|
|Job Published:||over 2 years ago|
Our client, a major multinational pharmaceutical company, now have a permanent role for an API subject matter expert (SME) to manage commercial API supply across CMO network. This permanent role, based in Dublin.
The successful candidate will provide technical support on manufacturing processes relating to manufacture and oversight for a portfolio of these externally manufactured commercial APIs, ensuring consistent security of supply across CMOs mainly based in Europe.
Ideal candidate will be a SME in all aspects of commercial API Manufacture i.e. API chemistry, process development, process management and troubleshooting, process scale-up, process robustness improvement, tech transfer and manufacturing support.
Responsibilities of Process Development Manager, API pharma:
- 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 Process Development Manager, API pharma:
- BSc in Chemistry or Chemical Engineering or Process Engineering. Ideally PhD in Organic Chemistry.
- 8 years' experience in an API manufacturing or development environment, with proven experience of process, engineering, analytical and regulatory aspects in cGMP manufacturing.
- SME level knowledge of API manufacturing i.e. API chemistry, process development, process management and troubleshooting, process robustness improvement, quality systems, etc.
- Demonstrated project management and technical leadership capability.
- Experience as the technical lead on API Technical Transfer projects.
- Confident management of internal and external stakeholder relationships
- Strong communication and negotiation skills, excellence business acumen.
20% of international travel associated with this role.
Please contact; Larry on +353 1 2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. http://www.rftgroup.ie/
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