Contract Development and Manufacturing Manager

Purpose

The ACDM, Contract Testing Laboratory (CTL) CW will work with CRO's/CTLs's to deliver on pipeline molecules. The CTL team in ACDM will develop the external sourcing strategy for commercial and development portfolio for external contract testing laboratory. The CTL team is part of the External Supply organisation is accountable for the execution of testing activities associated with the laboratory within scope.

Job Responsibilities include:

• 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, characterisation 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 Client'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), prioritisation 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 optimisation opportunities (timeline, budget, technical execution), prioritisation of a rolling portfolio of projects
• Supplier evaluation and selection
• This position will require occasional domestic and international travel

Basic Qualifications

• Master's Degree & 3 years of Scientific experience

OR

• Bachelor's Degree & 5 years of Scientific experience

Preferred Qualifications

• Advanced degree in engineering or the sciences.
• Experience in large molecule analytical development including method development, method qualifications/transfers/validations, release, stability and characterisation 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 organisations
• Strong understanding of cGMP, Regulatory/CMC, legal, Quality requirements and import/export policies
• Demonstrated understanding of drug development and commercialisation for synthetic and/or biologic therapeutics
• Experience as team member/leader of cross-functional and matrixed teams including effective writing, presentation, organisational and interpersonal skills to address a broad scope of audiences
• Proven business acumen, high level strategic thinking, and strong analytical skills with the ability to structure, pragmatically scope, and solve complex problems
• Demonstrated quantitative skills including experience in business process development, continuous improvement, operational excellence and performance management