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CMC Technical Program Manager – Drug Product

Job Title: CMC Technical Program Manager – Drug Product
Contract Type: Permanent
Location: Dublin
Industry:
REF: 123441
Contact Name: John Reid
Contact Email: johnr@rftgroup.ie
Job Published: 7 months ago

Job Description

CMC Technical Program Manager – Drug Product
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
Requirements of the CMC Technical Program Manager – Drug Product
  • 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 / johnr@rftgroup.ie / 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.