- Marburg an der Lahn
With operations in 35+ nations and ~ 20,000 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.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
For our Recombinant Product Development department we are looking for a
Senior Scientist Process Development (m/f/x)** - R-100931**
(fulltime / permanent)
Be part of our dedicated downstream development team and bring your passion to proactively drive:
- The development of state of the art protein purification processes in accordance with the requirements for Good Scientific Practice (GSP) and considering Good Manufacturing Practice (GMP) requirements.
- The scaling up of new processes.
- The transfer of newly developed processes to the next stage of development.
- The manufacture of material for non-clinical evaluation.
- Development and completion of documentation relating to the development of downstream purification processes or technical equipment to the relevant quality and regulatory standards.
- Supervision of Scientists and Lab Technicians
Main Responsibilities and Accountabilities
- Plan, perform, evaluate and document downstream protein purification experiments according to current scientific rationale and regulatory / internal guidelines and quality standards.
- Ensure accurate and precise data acquisition, collation and analyses for all protein purification activities using statistical tools such as DoE concepts and risk-based approaches such as QbD concepts.
- Develop and maintain facilities, laboratories and equipment to the required quality standards (as appropriate for GSP).
- Demonstrate excellent verbal and presentation skills (meetings and seminars) for communication of technical knowledge and information in accordance with core project and business objectives.
- Summarize experimental results or methods in reports, SOPs or other documents, in general In English.
- Actively seek new opportunities and manage establishment of new technology and new systems for the purification of recombinant therapeutic proteins
- Responsible for being the technical lead in operational and organizational collaborations with other departments and external partners
- Candidate must be a strong team player openly sharing expertise with other stakeholders in a global environment
- Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
- Resource planning and management of a small downstream development team by development and training of team members
- Usually M.Sc. in e.g. Biology, Biochemistry or similar; Phd of advantage
- Experience in project work and validation
- Experience with regulatory processes in the pharmaceutical industry
- Specialist knowledge in relevant analytical methods
- English Level 2
- 1-3 years of professional experience
EmployeeWorker Sub Type:
Regular Full time