Dynamic Analytical SME with extensive experience at Science Recruitment Group, excelling in method development and regulatory compliance. Proven track record in managing complex projects and driving continuous improvement. Adept at cross-functional collaboration and mentoring teams, ensuring quality and efficiency in laboratory operations. Strong analytical skills complemented by strategic thinking.
· Under little to no supervision coordinate, manage and execute technical activities internally and/or externally
for one or 2 assigned work packages to required quality, quantity, time and budget eg. DS/DP batch production, DS & DP process optimization, analytical method development & validation, stability program, route evaluation, form selection, material characterization.
· Design experiments/trials and studies
in accordance with Operating Model to support projects DS, DP or analytical development with little to no supervision.
· Analyse and interpret own data to influence decisions and next steps
. Collaborate & support laboratory technicians and scientists to deliver activities related to assigned work packages.
· Author quality protocols and reports according to data integrity requirements to support regulatory filings.
· Preparation of mock PAI and writing statement and mitigation plan in prevision of RTQ
· Support to VQL for analytical Dev.
· Support for investigation (internal and external)
· Contribute to the transfer of know how to other departments or external contractors, including troubleshooting and on-site training.
· Apply operating model to ensure the right things are done at right time relying on the strategy/guideline documents that will be embedded in the operating model.
· Openly collaborate with other SMEs to ensure technical activities requiring support from other teams or functions can be supported transversally and delivered to plans.
· Support DS, DP or analytical PL by providing resource and timelines for specific activities
.
· Openly communicate new risks, deviation from forecasted plans to DS, DP or analytical PL and sub-team members.
· Provide support related to area of expertise in audits and health authority’s inspection as required.
· Collate & support/mentor laboratory scientists in execution of experimental work
.
· Contribute to departmental goals & priorities in a collaborative manner.
· Contributes to departmental technical & scientific objectives as it relates to own area of expertise
· Maintain up-to-date knowledge of own area of expertise and participate in academic collaborations, scientific conferences and as a contributor to scientific publications, presentations and patents
Communicate address and solve problems within own area of expertise as they arise, identifying and implementing innovative solutions to resolve them.
Technical Project Management
Experimental Design and Data Analysis
Regulatory documentation and quality compliance
Cross-Functional Collaboration
White Belt Lean Basics