Specialist II, BTS

Requirements

• Good interpersonal, collaborative, and verbal/written communication skills, well organized, and able to work independently and make decisions in a team environment.
• Good conceptual, analytical, problem-solving, and critical thinking skills.
• Self-motivated and value-driven.
• Quality management and GMP knowledge in the biopharmaceutical industry (preferred).
• English Language skills, verbal and written (preferred).
• Required Skills:
• Preferred Skills:
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Additional Information

Job Description Position Overview - Basic Functions & Responsibilities Responsible for directing technology development, process development, and process improvement of the Large Molecule (LM) vaccine portfolio for all species. Activities are carried out in local projects with high complexity covering the discovery, pre-development, and development phase as well as transfer from R&D to Manufacturing, licensing, and implementation . Independently setting up and executing a project, focusing on processes for the development of new products, improvement of existing products, or solving problems in the production of existing products. Works together with Quality departments, Manufacturing LM site, R&D species teams, Discovery & Technology, Product stewards, Regulatory Affairs, Procurement, Supply Chain, and Network strategy to achieve our company AH business goals. Fulfilling research project management skills, research design, reporting, and presenting project (progress) reports. Interacting closely with fellow scientists within and other departments Primary Activities (Technical & General) Leads or co-leads at least a minimum of 2 projects at any given time, including the pre-development, pilot scale-up, transfer & commercialization, and provides technical support on the site. Is responsible for independent planning and executing a project/experiment. Can provide coordinating and substantive guidance on projects. Ensure regular, adequate, and complete reporting of the research carried out. Drives research on all used platform technology (e.g., bioreactor technology, RB, egg-based, RP, and Perfusion, formulations, emulsion, and Freeze-drying technology, etc.). This comprises the development of serum-free media, in vitro test development, improved downstream processes, new hardware for USP and DSP, single-use component technology, etc. Executes and owns regulatory documents such as study reports, OOP, batch records, SOPs, and MMIs for new drug applications, production departments, and Quality. Leads or members of transfer teams responsible for the transfer of production processes from site to site, and R&D to Manufacturing. Conducts literature study in connection with current or future projects. Communication and exchange of know-how between global BTS departments and Global R&D and Manufacturing to benefit from synergies and optimize utilization of knowledge and technology. Operational responsibility for the development of improved processes (upstream and downstream) and resolving manufacturing and supply issues of our vaccine portfolio according to the needs of Manufacturing. Co-leads or supports major Method development projects with a high degree of independence, in cooperation with R&D and Quality partners as appropriate Drives identification, feasibility assessment, and supports implementation of new technologies in cooperation with R&D and Quality partners Performs co-development/Single POC activities with a high degree of independence Minimum requirements Master's degree or above in a relevant field (e.g., Biology, Virology, Veterinary sciences, Biotechnology, Bacteriology, Bio-Engineering, and Molecular biology, etc.) with a minimum of 3 years of work experience in research institutes, universities, or the biopharmaceutical industry involving LM process development, assay development, method validation, technology transferring, etc. Practical knowledge and hands-on expertise regarding LM upstream process technology for biopharmaceuticals at laboratory and manufacturing scale, e.g., cell/viral culture, bioreactor, filtration, and/or purification process. Familiar with aseptic biopharmaceutical manufacturing process technologies, including any pilot scale, scale up/down, Design of Experiments (DoE), and statistical analysis to support the decision-making. Well-versed with good documentation practice and technical writing.

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