The Upstream Development Senior Manager plays a critical role in the development, technology transfer and streamlining of cell culture process to biologics as well as working directly with CMO's.
This position will be part lead a part technical with developing cell culture strategies and indulging in chemical development. They will also be supporting both early and late phase product development with scale up process mainly focusing on diseases in oncology and neurology.
In addition the senior manager will lead technology innovation and implementation efforts as well as support CMC regulatory approaches and industry initiatives in areas of expertise. The individual will also serve as lead in preparation of scientific publications in area of discipline or integrated disciplines as well as work in a multidisciplinary setting.
Functions:
- Guide the plan and oversee execution of analyses and scientific staff on the side of upstream interaction advancement
- From the early to late stages of the biopharmaceutical product lifecycle, use iterative experimental design methodologies to define cell culture and harvest operations
- Improve product and process knowledge, strategically include elements of Quality by Design as relevant to the development phase
- Support R&D programs, advocate for the implementation of new methodologies and technology, and ensure that best practices are followed
- In conjunction with R&D, Operations, Validation, and QA/QC teams, ensure the development and transfer of strong, scalable, well-characterized, and cost-effective upstream processes in alignment with project goals and schedules.
- Influence and steer project direction to promote product development goals with a high level of independence and attention to detail.
- For pilot plant and commercial campaigns, coordinate, prepare, and/or assist in the authoring, review, and approval of process development reports, technology transfer documents, raw material specifications, batch records, SOPs, and close-out reports
Requirements:
- Advanced understanding of protein expression systems, cell culture, and product harvesting techniques is required. Working understanding of PAT tools such as Raman spectroscopy and process intensification techniques is required
- Advanced analytical methods expertise and research skills to enable protein characterization and product quality assessment
- Experience with cGMP cell culture and equipment, such as large-scale bioreactors, mixing, and mass transfer
- Ability to excel in a "hands-on" environment
- Sets objectives and goals for direct subordinates; supervises, mentors, trains, and develops personnel.
