13 August 2019
(Applications close – 25 August)
The Recombinant Product Development group within R&D of CSL Limited is seeking a Manager, Formulation Development to help develop the next generation of protein therapies to treat serious medical conditions. Based at our site in Parkville (Melbourne) you will join a global network of scientists and engineers working across world class facilities to develop and manufacture recombinant protein therapeutics for evaluation in clinical trials.
As a senior R&D leader you will be responsible for the supervision and management of scientists, and provide expertise to the activities needed for successful development of safe, stable and efficacious biopharmaceutical formulations for clinical trials. You will also support the scale-up and transfer of new products and process to the next stages of development and conduct stability trials. As a skilled people leader you will oversee the professional development of scientists within the department and ensure records and documents meet business, quality and regulatory requirements.
Key Responsibilities Include:
- Plan and lead development strategies and activities for concurrent projects with timelines spanning preliminary development through to late stage stability, product characterization and process qualification.
- Provide technical, quality, operational and training expertise across the formulation team for experimental and business activities needed to support non-clinical and clinical studies, and new product registrations.
- Mentor, coach and develop formulation scientists in the diversity of technical and business competencies needed to master formulation development of new biopharmaceutical drug products.
- Lead and/or participate in global cross-functional teams on development and technology transfers of new product formulations and processes across R&D and manufacturing facilities.
- Manage the timely and accurate completion of documentation to business, quality and regulatory expectations.
- Manage activities that maintain departmental facilities, laboratories and equipment to required quality standards.
- Keep abreast of emerging trends and innovations within the industry and maintain the department at the forefront of industry best practice.
- May be assigned as technical lead on projects under development and throughout all stages of the product lifecycle.
To be successful you must possess:
- A relevant Tertiary Science Qualification, with Honours, (e.g. Bachelor of Science, Pharmaceutical Sciences, Biochemistry or relevant branch of Chemistry) with at least 8 years of industry formulation development experience, or, relevant higher degree with at least 6 years of industry formulation development experience.
- Strong and broad-ranging technical knowledge and practical expertise across several areas of science (chemistry, biochemistry, protein chemistry, formulation sciences, analytics & testing) as appropriate for the development of new biopharmaceutical formulations.
- Strong understanding and experience of the requirements for development of protein-based drug formulations for non-clinical and clinical uses.
- Strong record of applied scientific achievement in the development and/or characterisation of formulated proteins using modern technologies.
- Practical expertise with contemporary quality improvement concepts & tools, including statistical techniques relating to experimental design, data analysis and data management.
- Strong people leadership, communication and project management skills.
- Sharp business acumen and proficient problem solving abilities.
- Proactive and positive behaviours conducive to the establishment of effective teams.
Applications must address selection criteria and include a current CV and cover letter. Manager, Formulation Development
Applications Close Sunday 25th August 2019
Employment screening, including criminal history, medical assessment, confirmation of experience and stated qualifications, Australian working rights and other relevant checks form part of the candidate suitability evaluation process