Senior Immunoassay Strategy Lead (PK/ADA & Biomarkers)

Resolian Bioanalytics; Brisbane; On-site; AUD 180,000 - 240,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Scientific leadership

Team leadership

Client-facing communication

Regulatory knowledge

Education

Ph.D.

Job description

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