Bioprocess Engineer / Manufacturing Specialist
A leading and global biotechnology company is currently recruiting a Bioprocess Engineer/ Manufacturing Specialist to join their team in Germany. This is an excellent opportunity to work for a company that is dedicated to leveraging its current technology and expertise to develop innovative treatment options for patients.
- Working closely with the Director of Manufacturing to support the tech transfer and scale-up of the company's manufacturing process including Up-Stream-Process (USP), Down-Stream-Process (DSP) as well as final formulation and fill.
- Overseeing and managing the tech transfer and scale up operations at the Contract Manufacturing Organisation (CMO).
- Supporting national and international projects under consideration of local laws, international guidelines (ICH) and applicable SOPs.
- Planning and implementing scale-up from 200L to 2000L for USP, DSP as well as final formulation and fill.
- Supporting and managing the planning of Process Characterisation and Process Validation activities.
- Assisting in the qualification of suitable vendors in conjunction with Quality Assurance, if applicable.
- Writing/reviewing of GMP documentation (SOP, batch records, deviation, change control, out of specification, qualification and validation documents, risk analysis, etc.)
- Writing/reviewing of reports, batch summary reports, process validation reports.
- Participating in management reviews of process performance, product quality and the quality management system.
- Contributing to CMC core documents (e.g. IMPD, IND)
- Assisting with regulatory submission preparations.
- Providing requested input on forecast of annual budgets.
- Providing requested input to Product Development Plans and Portfolio Review.
- Actively participate in internal and external project teams.
- Representing the Company at external conferences and meetings.
Skills and Requirements:
- Post graduate 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 (e.g. 2000L).
- Understanding of QC techniques applicable for biologics.
- Background in Process Characterisation and Process Validation to support BLA / MAA
- Experience of writing and or review of GxP documents (including SOP's, qualification/validation plans/reports, batch records).
- In-depth working knowledge of EU GMP.
- Experience of equipment and method qualification / validation.
- Experience of working in or liaison with a Contract Manufacturing Organisation.
- Experience in manufacturing recombinant protein / antibody / fusion protein.
- Background in CHO cell manufacturing.
- Experience in viral safety evaluation.
- Experience in scale-down models.
- Knowledge of US GM.P
- Good working knowledge of using Microsoft office programs
- Multifunctional interesting tasks in the emerging field of immune therapeutics.
- Highly motivated and energetic international team.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Antoine Mortiaux at firstname.lastname@example.org or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.