Director Scientific Operations

360biolabs is Australia's most comprehensive quality-accredited specialty laboratory services organisation. 360biolabs is a BioAgilytix company and part of a leading global contract research organisation (CRO) supporting the development of innovative new medicines in a quality-controlled environment. At 360biolabs, we develop and conduct pharmacokinetics (PK) and pharmacodynamic (PD) assays across a wide variety of therapeutic areas to ensure the success of our clients' clinical trials and preclinical studies.

Working at 360biolabs means working with the best people (and technology) in our field. With a genuine focus on development, you will have access to local and global opportunities. You will also have access to a diverse offering of wellbeing and connection initiatives which reflects that people are our priority.

The purpose of this role is to provide leadership, operational excellence and management of 360biolabs’ Scientific Operations function and ensure that the group supports pharmacokinetic and pharmacodynamic endpoints for clinical trials and preclinical studies as part of an integrated service adhering to best industry practice and all relevant regulatory guidelines. This role will also be required to coordinate diverse functions that support Scientific Operations processes within 360biolabs.

Key Responsibility Areas:
• The key responsibility areas (KRAs) are the major outputs for which the position is responsible and are not a comprehensive statement of all position activities.
Operational Excellence
• Collaborate well in a cross functional matrix environment and maintain high levels of communication with colleagues (local and global) and productive relationships with clients, CROs, collaborators and partners
• Coordinate multiple departments across the Scientific Operations functions, including key scientific disciplines and support functions
• Take a leadership role in the business’ operational excellence to drive greater efficiency, connectivity between teams and systems, and business workflows
Technical and Laboratory
• Take a leadership role in the coordination of method development, optimisation and validation of bioanalytical methods and assays for use in human and animal studies.
• Troubleshoot assays for research projects, preclinical studies and clinical trials in consultation with bioanalytical and clinical teams.
• Expand company’s range of bioanalytical services and maintain awareness of competitive landscape
• Maintain current knowledge to accurately interpret, consult, and train staff on applications, compliance trends and methodologies.
• Ensure EVP Scientific Operations is kept informed of progress and key risks to ensure timeframes and expectations are met.
Data Analysis and Reporting
• Take a leadership role in the preparing, maintaining and reviewing policies, SOPs, systems and procedures necessary to support bioanalytical instruments and assays to assure the quality and integrity of service offerings at 360biolabs
• Maintain records to levels consistent with relevant standards and industry expectations
• Perform data integrity reviews and provide clear interpretation of data to others
• Prepare and review, validation protocols, validation reports and study reports (as required)
• Perform data transfers and reconciliations as described in Data Transfer Agreements (as required)
• Produce and review reports and presentations for internal use and communication to clients and external bodies
Leadership
• Managerial oversight of multiple Scientific Operations teams including managing priorities, supervision, training and staff development, performance reviews, 1:1s and providing regular feedback
• Provide leadership to drive the work ethic and culture of the scientific group as a whole
• Proactively manage strategic relationships between internal resources and external entities such as vendors, clients and partner organizations
• Participate in defining milestones (Company, Group and Study) and ensure activities are aligned to deliver goals
• Collaborate with other functions and departments to ensure a unified approach to change management is supported
Client Interactions and Management
• Represent the company and the Scientific Operations group in interactions with clients from initial technical discussions through study initiation, execution and reporting
• Liaise with colleagues and client representatives to ensure study activities are delivered consistent with Work Orders and timelines
• Fulfill the role of Study Director (as required)
Safety
• Ensure the safe and efficient conduct of company activities
• Ensure compliance to relevant internal processes and statutory requirements
Accreditation
• Adhere to ISO/IEC 17025, OECD Principles of GLP, the 360biolabs’ Quality Management System, SOPs, and other requirements as per NATA Accreditation and regulatory guidelines.
• Maintain awareness of, and ensure compliance with, relevant International Standards and Guidelines
Professional Development
• Attend and actively participate in company meetings including project and client management, departmental and laboratory meetings where appropriate
• Participate in professional activities including attendance at conferences, training courses and seminars in the field of expertise
• Maintain awareness of new assay technologies and other developments relevant to assay validation and development and make recommendations for improvements

Key Selection Criteria:
• BSc in a Bioanalytical discipline (Essential)
• PhD in a Bioanalytical discipline or equivalent experience plus research or industry leadership experience (Essential)
Experience / Knowledge / Attributes
• Extensive experience in medical laboratory techniques (for example in a quality-controlled environment, preferably an accredited facility following ISO/IEC 17025 or similar) (Essential)
• Experience in assay validation and knowledge of ICH, FDA and EMA assay validation guidelines (Essential)
• Experience in method development and validation of bioanalytical methods for the detection and quantitation of compounds from various matrices (Essential)
• Experience in testing therapeutic drugs, immunotherapies and/or vaccines preferably in an industry or contract research environment. (Essential)
• Extensive experience and knowledge in a scientific discipline, including the practical execution of assay procedures and the analysis and interpretation of assay results (Essential)
• Extensive experience in leading and motivating a cross functional team (Essential)
• Excellent organisational and report writing skills (Essential)
• Experience with database computer software and file management (Essential)
• Ability to work as part of a team and collaborate with others (Essential)
• Excellent analytical, interpersonal, verbal and written communication skills (Essential)
• High motivation and enthusiasm for medical research, drug and vaccine development (Essential)

Apply now if you have what it takes to join our team!

360biolabs is a flexible, equal opportunity employer looking for committed and like-minded people to join us. Our culture is something we are very proud of, celebrating each individual and everything they bring to our team. We encourage applications from Aboriginal and Torres Strait Islander people, all members of the LGBTQIA+ community and people with a disability.

To express your interest in this position please submit a CV and cover letter. Applications only accepted from Australian / NZ residents with valid Australian work rights.

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