Technical Operations Associate Director, Biologics
|Job Title:||Technical Operations Associate Director, Biologics|
|Contact Name:||Larry O’Leary|
|Job Published:||over 1 year ago|
Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research. This newly created role, Associate Director Technical Operations will join the Manufacturing Support team based in their Dublin office.
The successful candidate will provide scientific and technical leadership to our external commercial partners for large and/or small molecule DS/DP.
Responsibilities for Technical Operations Associate Director:
This position is responsible for providing strong scientific leadership for all aspects of technology transfer, process scale-up, process monitoring, and process troubleshooting to drug substance, drug product and finished product manufacturing activities for large and/or small molecules.
This responsibility includes all process validation activities.
Other responsibilities will include cross-functional team leadership and / or membership, authoring technical reports and supporting CMC aspects of regulatory dossiers.
The role will involve significant cross functional collaboration with other functions including R&D, external manufacturing and Quality, working towards existing and new product introduction and ensuring all processes are understood, robust, efficient and in control.
Requirements for Technical Operations Associate Director:
Bachelor?s degree in relevant scientific discipline. Advanced degree (MSc, PhD) desirable.
Proven project management skills for technical programs ideally complemented with Project Management qualification.
Experience of both small and/or large molecule technologies, with demonstrated technical expertise in process development and NPI.
Proven experience in process characterization and development to identify process boundaries and critical process parameters.
Demonstrated track record of training and coaching colleagues to improve overall team process knowledge.
Experience in defending processes, procedures and investigations during FDA/EMA inspections is desirable.
For further details, 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. / www.rftgroup.ie
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