Would you like to work for one of the market leaders within the pharmaceutical sector? I have a fantastic exclusive opportunity with one of the market leaders looking for a Drug Product CMC Technical Manager.
The CMC Technical Program Manager – Drug Product will coordinate global technical (CMC) support activities for Biologic Drug Product registration and post-registration stages of the product lifecycle.
This role is a permanent role based in Dublin.
Responsibilities of CMC Technical Program Manager – Drug Product
- Coordinate global technical (CMC) support activities for Biologic Drug Product registration and post-registration stages of the product lifecycle.
- Troubleshooting, process improvement, cost reduction, capacity expansion, technical transfer and validation responsibilities.
- Work closely with Process Development, Supply Chain Operations, Quality Assurance and CMC-regulatory Affairs, while serving as a key point of technical contact between client and multiple contract service providers.
- Lead the development and successful implementation of new concepts, techniques, and standards.
- Serve as a key knowledge link between Process Development, Supply Chain Operations and other technical services groups.
- Providing technical support for quality systems governing GMP manufacturing (e.g., deviations, investigations, CAPA and change control), regulatory submissions, and facility inspections.
- Serve as technical review/approval for manufacturing related documents such as Change Notifications, APQR and MBR.
- Interact with and influence with external partners, e.g., CMOs and CRO
- At least 5 years of professional experience in a similar role in the field of Technical Operations, Process Management, Manufacturing within the pharmaceutical industry, preferably biotechnology
- Degree in technical / scientific education, pharma.
- Knowledge and experience relating to the application of Quality by Design principles and statistical analysis tools for evaluation of Drug Product manufacturing processes.
- Six Sigma and Statistical knowledge is an advantage.
- Broad knowledge and experience within the GMP environment, and regulatory affairs.
- Successful track record of change management projects and processes
- High level of customer orientation and organizational skills
- International background appreciated
In strict confidence please send an up to date CV and cover letter to John Reid at The RFT Group / email@example.com / on 01-2302400 / www.rftgroup.ie
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The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.