We have an opportunity available for a CMC (Chemistry, Manufacturing, Control) Site Lead to join our R&D team in Melbourne, Australia. In this senior leadership role, you will be accountable for the designated site and global CMC activities. Reporting into the Senior Director CMC Lead PPD, you will manage the local CMC team as well as act as the CMC lead on designated projects.
The CMC Lead role will be responsible for project-specific CMC teams accountable for CSL plasma product development (PPD) projects. Your primary responsibility and accountability is to define and deliver contemporary CMC packages during clinical development, market authorization, and Life Cycle Management (LCM). During early clinical development, you will define the clinical material manufacturing plan and ensure clinical supply.
To accomplish these objectives, you will provide direction, technical expertise, coordination and oversight of cross-functional, global and local CMC Delivery teams.
As a leader, you will ensure appropriate and continuous communication with Research, Development, Operations and global CMC groups relating to topics interfacing with CMC and associated activities.
- Ph.D., Masters, or BSc (or equivalent) in Biochemistry, Biology, Engineering or related field.
- Minimum 10 years of experience in pharmaceutical industry with emphasis on CMC package delivery, product development, manufacturing, process design / implementation, technology transfer and process validation.
- Demonstrated experience in project management and or leadership by influence preferred.
- Advanced knowledge of biological manufacturing processes and advanced CMC/QbD requirements for plasma derived or biotechnology therapies is preferred along with technical and regulatory writing experience.
- Previous experience working across sites and as part of international teams is highly desirable.
- External recognition as a scientific expert in the field of CMC/QbD or similar is preferred.
- Written and verbal fluency in English is required, fluency in Mandarin is highly desirable
- Demonstrated ability to work effectively with and help others on interdisciplinary teams to accomplish objectives.
- Due to the global nature of this position, a willingness to adopt flexible working hours and travel is expected.
With operations in 35+ nations and ~ 25,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
Applications must address the selection criteria above and include a current CV and covering letter.
Employment screening, including criminal history, medical assessment, confirmation of experience and stated qualifications and other relevant checks form part of the candidate suitability