Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
Effectively demonstrates behaviors and performance characteristics as described in our core values
Demonstrates full understanding of regulatory requirements (GLP, GCP, GMP, EPA, OECD, CLIA, 21CFR Part 11) and apply as required by operational area
Demonstrates effective communication skills through both informal and formal discussions with peers, supervisor, internal teams, across the organization, and externally with Regulators and Sponsors
Maintain and demonstrate critical thinking, troubleshooting and time management skills aligned with the needs of the operational area
Ensures that operational area is clean and inspection ready at all times
Independently and efficiently execute the completion of laboratory investigations, assay and equipment troubleshooting, and quality observations.
Effectively act as a technical resource for troubleshooting activities
Independently and accurately prepare reagents, standards and control samples
Independently and accurately perform laboratory support functions such as labeling, monitoring expiration dates, and solution preparation
Independently and accurately execute routine sample analysis studies with increased throughput and workload
Independently operate and maintain analytical instruments as required by operational area
Independently and accurately perform data analysis in appropriate software for a majority of analytical platforms




Demonstrates a complete understanding of what constitutes a passing or failed run
Demonstrated ability to independently recognize method and/or data issues, communicate them to management, and propose solutions to minimize study impact
Independently and accurately executes method validation and qualification projects with increased workload as required by operational area
Independently designs and accurately executes complex method development projects as required by operational area
Independently prepare accurate summaries of method development data
Demonstrates a complete understanding of compliance and regulations by independently and accurately writing both study and non-study deviations
Independently and effectively function as a liaison, maintaining timely and frequent communication with the Sponsor as required by operational area
Actively communicate and collaborate across operational areas in order to adhere to timelines and produce quality data
Independently ensure the scientific integrity of studies as required by operational area
Maintains an awareness of team workload and routinely provides support to other staff members
Independently and effectively review laboratory documents and notebooks (e.g., plans, experiment/sample runs, validation files,



reports, chromatograms, instrument logs, etc.) for compliance to SOPs and applicable regulations as required by operational area.
Independently and accurately review system audit trails as required by operational area as needed
Effectively lead internal process improvements, presentations and harmonization efforts
Actively looks for suitable opportunities to publish or present work, both internally and externally
Effectively assist in the training of recent staff members for all functions as required by operational area as needed
Effectively assists in the review of proposals and highlights any concerns to Management and/or Business Development as required by operational area as needed
Requirements
Ph.D. degree with at least 3 years or M.Sc.
degree with at least 5 years of working experience in immunology, biochemistry or analytical chemistry (especially in quantitative immunoassay) or an equivalent combination of education, training, and experience as deemed appropriate by management
Technic expertise in using ELISA or MSD platform to develop and validate methods for pharmacokinetic studies and anti-drug antibody studies
Family with ICH M10 guidance is a plus
Thorough understanding of the requirements and applicability of GLP, GCP and 21 CFR Part 11.
Ability to work effectively in a team and independently
Excellent communication skills (writing and speaking).
Knowledge and understanding of the pharmaceutical industry; CRO working experience is desirable
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📌 Sr. Scientist I Immunoassay (Brisbane)
🏢 Resolian Bioanalytics
📍 Brisbane