ProClinical is currently seeking a Head of Bioprocessing role for a global biopharmaceutical company with extensive experience in drug development. The Head of Bioprocessing position will be responsible for leading development and characterization of upstream processes for production of therapeutic proteins, mammalian monoclonal antibody production, microbial fusion protein production is a plus. Provide subject matter expert leadership in cell culture and fermentation process design and scale up, especially in single use technology. Knowledgeable in purification process. Leading company effort to establish and operate a mammalian cell culture pilot facility
- Provide functional leadership to establish phase I-III clinical production processes, including oversight of process transfer, scale-up, validation and product/process comparability. Responsible for hiring and managing an upstream team of scientists and engineers.
- Act as principal technical representative on the technology transfer teams and product development project team for specific products. Responsible for managing the relationship between R&D or third-party clients.
- Design and implement rigorous upstream process and product development strategy for the group, utilizing DOE and other process design elements aligning with a QbD approach.
- Plans, assigns, directs and evaluates the work of technical staff assigned to the project and ensures the project schedule and cost target are met through proactive identification of risks and managing cross-functional issues to resolution.
- Prepare project update presentations for senior management; direct the preparation of development reports and sections for regulatory submissions.
- Contribute to evaluations of potential fit of prospective new products from a technical and cost perspective
Skills and Requirements:
- PhD degree in an applicable scientific discipline such as biochemistry, microbiology, chemical engineering or related discipline.
- Minimum required applicable experience is 7-10 years for a PhD with 5 years' experience in a management role. Oversea experience is a plus.
- Demonstrated expertise with a range of laboratory techniques associated with clarification, cell culture, cell line development
- A broad range of experience with mammalian products
- Ability to define problems, collect and analyze data, and draw conclusions
- Good written and oral communication skills
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 call Vincent Ng on +65 6499 7148 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.