Purpose
The Contract Testing Laboratory (CTL) contract worker will collaborate with CROs and CTLs to support the delivery of pipeline molecules. The CTL team develops the external sourcing strategy for commercial and development portfolios related to outsourced contract testing laboratories. As part of the External Supply organisation, the CTL team is responsible for executing laboratory testing activities within its defined scope.
Responsibilities
* 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.
* 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 optimisation opportunities (timeline, budget, technical execution), prioritisation of a rolling portfolio of projects
* Ensure that designated 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
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 organizations
* 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