Director, Upstream Process Development
Ph.D. in Chemical/Biochemical Engineering or related Biological Sciences with:
7+ years of exceptional and visionary leadership with a focus on building strong and productive teams.
10+ yrs of industrial experience in the Pharmaceutical/Biotech industry.
Demonstrated experience in developing cell culture processes for the production of bio-pharmaceuticals.
A very good understanding of the cGMP requirements of manufacturing processes for biopharmaceuticals.
A good understanding of challenges faced during scale-up.
Experienced in technology transfer to manufacturing sites.
Hands-on experience with process scale-up/process characterization.
Experienced in authoring of CMC sections for regulatory filings, including BLAS/MAA.
Familiarity with current QbD approaches and Control Strategy Development.
Supervisory experience leading technical teams.
A thorough knowledge of the workings of large scale bio-reactors, especially aspects concerning mass transfer and mixing times
Good communication skills and ability to work in matrix teams.
Authoring and review of BLA & MAA drug substance modules
Detailed knowledge of Process Validation requirements.
Working knowledge of PAT tools such as Raman; NIR;
Demonstrated mastery of handling large sets of data including statistical analysis using software packages such as JMP; SIMCA, etc.
Detailed knowledge of multivariate analysis and DoE approaches.
The Director for Upstream Process Development will be a strong and visionary leader for a team of 10-12 exceptionally talent and experienced scientists and engineers. This team is responsible for developing late stage cell culture processes for the manufacture of biopharmaceuticals using mammalian expression systems. You will also lead a team of scientists and engineers involved in the scale-up and technology transfer of manufacturing processes to produce Phase-3 clinical supplies and commercial-scale protein production. You and the team will also be responsible for authoring and reviewing technical reports, protocols, technology transfer documents and CMC sections in regulatory filings. You will represent and be the voice of the department on project teams and is also expected to interact on a routine basis with colleagues in process development, analytical and commercial manufacturing as well as regulatory groups.
In addition, you and the team will lead and participate in on-going technology development efforts within the Department. These include developing of proprietary cell culture media and feed and PAT for cell culture processes.
You will participate in strategic planning for the direction of the Department and the BioPharm CMC organization. You will make presentations to senior management providing periodic progress updates on projects and proposals for new technology development initiatives. You will comply with all the requirements of GSK policy and be a model of ethics and integrity.
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