Contract Development & Manufacturing Manager (hybrid)
RK4894
Contract 12 months
Dublin



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



Duties:

• Laboratory Supplier relationship management, including development and reporting of metrics and monitoring performance to continuously improve efficiency and effectiveness of suppliers. Building and maintaining strong partnerships with all external laboratory functions to increase overall effectiveness and success of programs. Ability to operate in highly matrixed teams.
• Project management of a portfolio of cross-disciplinary external projects traversing the areas of Drug Product, Drug Substance, and Attribute Sciences. Primary focus will be to manage delivery of analytical work packages (method qualification, method transfer, release testing, stability testing, characterization sample management ) with external contract laboratories
• Actively participate in cross-functional teams with clear accountability for performance and ensure the quality, cost, and delivery of products from Amgen's Contract Testing Laboratory sites are consistently met, as well as lead issue resolution, problem solving and serve as an escalation agent.
• Responsible to ensure analytical escalations are captured and communicated accurately and timely
• Identification of project optimization opportunities (timeline, budget, technical execution), prioritization of a rolling portfolio of projects
• Ensure that designated ACDM lead programs meet compliance, speed, quality, and cost targets through strong scientific and technical understanding of the programs and drug product development.
• Identification of project optimization opportunities (timeline, budget, technical execution), prioritization of a rolling portfolio of projects
• Supplier evaluation and selection
• This position will require occasional domestic and international travel

• Bachelor’s or Master’s degree in Science, Engineering, Biotechnology, or related discipline.
• 5 years experience in large molecule analytical development including method development, method qualifications/transfers/validations, release, stability and characterization testing.
• Self-starter with a high-level of comfort with ambiguity and complexity and the ability to multi-task while consistently delivering quality results
• Experience interfacing with domestic and international CTL /CRO organizations
• Strong understanding of cGMP, Regulatory/CMC, legal, Quality requirements and import/export policies