Senior Director Global Bioanalytical Sciences - Jobs in Victoria

Job Description

Senior Director Global Bioanalytical Sciences Position PurposeThe Senior Director, Global Bioanalytical Sciences (GBS) is responsible for analytical development for recombinant proteins, monoclonal antibodies and Viral vectors in CSL #39;s R amp;D portfolio from preclinical development through to expand for commercial manufacture and BLA/MAA submission, across CSL #39;s Australian and German sites.You #39;ll be responsible for analytical method development and validation, product characterization, comparability, analytics to support process development, assay transfer and analytical strategy for regulatory submissions, and GMP release testing for Phase 1 and 2 clinical trial material.You will manage a global department of about 70 scientists and managers, associated budgets and capital projects across the CSL Germany (Marburg) and Australian (Melbourne) sites. Your role is strategic, important in developing wider Biopharmaceutical Product Development strategy following developments in regulatory guidance, technological advancement, best practice definition and agreement on mid- to long-term R amp;D goals.Responsibilities:

• You promote bioanalytical expertise for recombinant protein product development in CSL Innovation Australia and CSL Behring Innovation (Marburg).
• Lead bioanalytical development in the wider context of product development including:
• You align policy with developments in regulatory guidance e.g. ICHQ2A/Q2B/Q5E/Q8/9/10/11 and FDA/EMA guidance on process validation.
• You define best practice in bioprocess development e.g. application of DOE methods, use of numerical risk assessments, application of principles of Quality by Design (QbD), implementation of high throughput approaches and technologies.
• With the Biopharmaceutical Product Development (BPD) leadership team, develop and implement mid to long term strategic goals for the department, including:
• Develop, review, maintain a long-term strategy for BPD, to ensure the organisation can meet future portfolio demand e.g. from a maturing pipeline.
• Ensure CSL bioanalytical development practices compare well with the industry benchmark.
• Map skills, resources, and capital requirements to our needs, ensuring readiness for portfolio developments.
• Manage the analytical outsourcing strategy
• Inspire creativity
• Provide leadership of GBS departmental operations, facilities, resources and staff, including:
• Manage, motivate and develop bioanalytical talent at all levels.
• Preparation and assessment of performance goals.
• You manage main departmental activities and operational expenses
• Ensure data integrity and scientific rigour for bioanalytical activities; maintain proficiency in DOE and statistical methods.
• Embed analytical Quality by Design (AQbD) principles into analytical development practices.
• Ensure compliance to GMP requirements for Phase 1 and 2 clinical trial material release testing.
• Ensure staff are trained in all technology required to maintain scientific excellence in the field.
• Ensuring all facilities and equipment are maintained in a state of operations fitness for purpose and compliance
• Identify advances in technology and equipment in relevant fields, implementation of such within CSL and definition of best practise.
• Ensure compliance of departmental practices with CSL policies, AQIS and HSE requirements.

Qualifications:

• Post graduate qualifications in relevant branch of biological science or engineering. At least 10 years #39; experience in related bioanalytical development activities.
• Expertise in protein chemistry and analytical method development.
• Create a strategic vision for bioanalytical development in the wider context of drug development.
• Outward looking; able to represent Biopharmaceutical Product Development beyond the bioanalytical science area.
• Influential in interactions with main business contacts (internal and external).
• Able to communicate goals, motivate teams, develop talent.
• You are esults driven; able to delivery to target and organise teams to do so.
• Excellent oral communication skills.
• Excellent written skills; able to coach others to produce documentation meeting required standards.
• Knowledge of wider drug development and regulatory requirements.
• Knowledge of early and late-stage process development, product characterisation, assay transfer and validation, GMP and quality management systems (QMS).
• Skills in data analysis, interpretation, statistical methods and problem solving.

Our BenefitsWe encourage you to make your well-being a priority. It #39;s important and so are you. Learn more about how we care at CSL.About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversityamp; Inclusion at CSL.Do work that matters at CSL Behring! Create a job alert and receive personalised job recommendations straight to your inbox.