Associate Director, Immunoassay (Brisbane)

Resolian Bioanalytics; Brisbane; Sur place; AUD 180 000 - 240 000; Plein temps

Résumé du poste

Resolian Bioanalytics in Brisbane, Australia, seeks a scientific leader to drive the immunoassay function, setting strategy for PK, ADA, NAb and biomarker assay development and validation in line with regulatory guidance. You will own data quality and project delivery, lead a team of scientists, expand capabilities, and represent the function externally at client meetings and scientific forums.

The role requires translating scientific insights into competitive proposals, managing deviations, and

Qualifications

• Ph.D. with 7+ years in a CRO bioanalytical lab, expert in immunoassay development and validation.
• Proven experience leading and developing a team of scientists.
• Regulatory knowledge: GLP, GCP, GCLP, 21 CFR Part 11, bioanalytical validation guidance.
• Ability to set scientific strategy and own data quality in a regulated environment.
• Experience leading deviation investigations and client audits/regulatory inspections.
• Strong communication, presentation, and client-facing skills; cross-functional collaboration.

Responsabilités

• Set scientific direction and strategy for immunoassay development and validation.
• Own scientific quality and delivery of projects, ensure methods fit for purpose.
• Lead and manage a team of scientists and support career progression.
• Represent immunoassay externally with clients and at scientific meetings.
• Review and approve methods, validation plans, data, and reports.
• Drive business growth as scientific lead in client discussions and bid defense meetings.

Connaissances

Scientific leadership

Team leadership

Client-facing communication

Regulatory knowledge

Formation

Ph.D.

Description du poste

Provide scientific leadership for the immunoassay function, setting the strategy and technical direction for PK, ADA, neutralizing antibody and biomarker assay development and validation in accordance with applicable regulatory guidance. Act as the scientific authority and owner of data quality and project delivery, lead and develop a team of scientists, expand laboratory capabilities and capacity, and drive business development through scientific leadership of RFP review and client engagement. This is a key role in the succession planning for the site as the group grows.

Key Responsibilities:

Set the scientific direction and strategy for immunoassay (PK, ADA, NAb and biomarker) development and validation, defining technical standards, platform choices and the capability roadmap in line with applicable regulatory guidance and client needs

Own the scientific quality and delivery of development and validation projects, critically reviewing data and assay performance to ensure methods are fit for purpose and projects meet quality standards, regulatory expectations and client timelines

Serve as the scientific authority for complex assay development, validation and sample analysis challenges across methods and platforms, providing expert troubleshooting and hands-on technical input where needed

Lead and manage a team of scientists, setting objectives, managing performance, supporting professional development and career progression, and contributing to recruitment and succession planning

Build scientific capability by developing and delivering practical and theoretical training in assay development, validation, troubleshooting and data interpretation, and by mentoring scientists as future technical leaders

Represent the immunoassay function externally with clients and at scientific meetings.

Review and approve methods, validation plans, data and reports, ensuring scientific integrity, data quality and compliance with applicable regulations and SOPs

Lead scientific investigations into deviations and assay failures, determining root cause and corrective and preventive actions, and act as the scientific representative for immunoassay during client audits and regulatory inspections

Evaluate, select and implement new technologies, platforms and assay approaches to expand immunoassay capabilities and meet evolving client and regulatory needs

Partner with site leadership to plan resources, laboratory capacity, workflows and equipment investment, prioritizing workload across projects to meet business and client demand

Lead the scientific review of requests for proposals (RFPs), determining feasibility, assay strategy, scope, resources and timelines to deliver scientifically sound, competitive proposals

Drive business growth as the scientific lead in client discussions and bid defense meetings

Requirements

Required Qualifications:

Ph.D. with 7+ years relevant working experience in a CRO bioanalytical lab, with demonstrated scientific expertise in immunoassay (PK, ADA, NAb and biomarker) development and validation

Proven experience leading, managing and developing a team of scientists, including performance management and mentoring future technical leaders

Expert knowledge and understanding of regulatory requirements and guidance (GLP, GCP, GCLP, 21 CFR Part 11, and current bioanalytical method validation guidance) and their application to assay strategy and study conduct

Demonstrated ability to set scientific strategy, make sound technical decisions and take ownership of data quality and project delivery in a regulated environment

Experience leading deviation investigations and representing the laboratory scientifically to clients during client audits and regulatory inspections

Excellent communication, presentation and client-facing skills, with the ability to influence stakeholders at all levels, collaborate across functions and represent the company externally as a scientific leader