An emerging, international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases are looking for a Manufacturing Manager to join the business. With operations based in Australia, USA, Germany and France, the business is dedicated to bringing innovative treatment options to market for patients.
As a result of continuous progress in their projects, they want to expand the team and therefore seek a Bioprocess Engineer / Manufacturing Specialist. You will work closely with the Manufacturing team and help support the tech transfer and scale up of the manufacturing process including USP and DSP ,as well as final formulation and fill. Your responsibility includes to oversight and manage the tech transfer and scale up operations at the Contract Manufacturing Organization (CMO). This implies the supporting of national and international projects under consideration of local laws, international guidelines (ICH) and applicable SOPs.
Job description:
- Planning and implementing scale-up of manufacturing processes of biologics for USP, DSP as well as final formulation and fill
- Support and manage the planning of Process Characterization and Process Validation activities
- Assist in the qualification of suitable vendors in conjunction with Quality Assurance, if applicable
- Writing / review of GMP documentation (SOP, batch records, deviation, change control, out of specification, qualification and validation documents, risk analysis, etc.)
- Writing / review of reports, batch summary reports, process validation reports
- Participate in management reviews of process performance, product quality and the quality management system
- Contribute to CMC core documents (e.g. IMPD, IND)
- Assist with regulatory submission preparations
- Provide requested input on forecast of annual budgets
- Provide requested input to Product Development Plans and Portfolio Review
- Actively participate in internal and external project teams
- Represent the Company at external conferences and meetings
Skills/Experiences/Qualifications:
Essential:
- Master's degree in natural / life sciences / engineering background
- At least 5 years of experience in an industrial GMP manufacturing / clean room environment preferably with biologics
- Experience of tech transfer of processes and scale-up to commercial scale
- Understanding of QC techniques applicable for biologics
- Background in Process Characterization and Process Validation to support BLA / MAA
- In depth working knowledge of EU GMP
- Experience of working in or liaison with a Contract Manufacturing Organization
- Experience in manufacturing recombinant protein / antibody / fusion protein
- Background in CHO cell manufacturing
- Experience in viral safety evaluation
- Fluent English