Scientific Leader (Associate Director Level), Upstream Process Development
Location: Pennsylvania
My client is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market.
This is a highly experienced Chemistry, Manufacturing and Controls (CMC) organization accountable for delivering robust, cost effective and competitive products and manufacturing processes spanning the full life-cycle of asset development from Discovery through commercialization. These activities are delivered through state-of-the art internal facilities as well as strategic external partners. Collectively, the team is accountable for CMC activities encompassing cell line development, cell culture/ microbial fermentation, purification development, and drug product/ device development
Within this team, the Microbial and Cell Culture Development department is responsible for the development of cell culture processes for the manufacture of assets. The Department is also responsible for the scale-up and tech transfer of the processes to manufacturing facilities all over the world.
In this role, the candidate will lead a team of 4-6 scientists responsible for developing late stage cell culture processes for manufacturing biopharmaceuticals using mammalian expression systems. This team is involved in the scale-up and technology transfer of manufacturing processes for the production of Phase-3 clinical supplies and commercial-scale protein production. You and your team will also be responsible for authoring and reviewing technical reports, protocols, technology transfer documents, and CMC sections in regulatory filings. In addition, you and your team will lead and participate in on-going technology development efforts within the Department. These include the development of proprietary cell culture media and feed, improving the efficiency and productivity of our platform processes, and the application of PAT for cell culture processes.
Responsibilities:
- Manage and provide development opportunities for of a small team of junior scientists
- Represent the department on project teams
- Lead and participate in ongoing platform development initiatives including the development of perfusion/continuous upstream processes and technology development efforts
- Participate in strategic planning for the direction of the department and the CMC organization
Qualifications:
- PhD or equivalent experience in Chemical/Biochemical Engineering or related Biological Science with 7+ years of industrial experience in the Biotech industry
- Experience in developing cell culture processes for biopharmaceutical production with exposure to cGMP requirements
- Experience in technology transfer to manufacturing sites
- Hands-on experience with process scale-up/process characterization
- Experience in authoring CMC sections for regulatory filings
- 4+ years of supervisory experience leading technical teams
Preferred Qualifications:
- Familiarity with current QbD approaches and Control Strategy Development
- Very good understanding of small-scale model qualification and challenges faced during scale-up
- 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, capacitance probes, and in-line UV measurements
- Demonstrated mastery of handling large sets of data, including statistical analysis using software packages such as JMP/SIMCA/etc.
- A thorough knowledge of the workings of large scale bio-reactors, especially aspects concerning mass transfer and mixing times
