This individual will be responsible for complex programs related to viral vector production. They will support the group regarding upstream responsibilities.Essential Functions:
Required Education & Experience:
- Executes multi-faceted and sophisticated client and innovation programs.
- Quickly solves day-to-day experimental difficulties using established platform methodologies and problem-solving skills.
- Conducts tests on a bench and pilot scale, encompassing all areas of viral vector upstream production.
- Supports process development and characterization, evaluates process improvements, and resolves potential processing concerns by applying fundamental scientific and engineering principles to viral vector and protein manufacturing processes.
- Supports regulatory submissions with oral presentations and written material, including technical reports and GMP documents.
- Works in cross-functional teams with representatives from Process Development, Project Management, Manufacturing, and Quality to develop and implement feasible / practical clinical/commercial manufacturing solutions.
- Provides scientific and technical support for the transfer of processes from development to production.
- Contributes to technology development by thinking outside the box.
- Utilizes design of experiments and statistical analysis of data.
- Primary project contact with a client and must be articulate around the science and problem solving
- Supervises a group of junior scientists and research assistants.
- Ensure project deliverables are met by managing timeframes and coordinating resources with function heads.
- PhD in Molecular Biology, Biochemistry, Chemical/Biochemical Engineering, or a similar field with at least 5 years of in-depth technical experience in the development of production processes for viral vectors and large molecules from mammalian and insect cells.
- A solid understanding of production process engineering and process scale-up/scale-down design is essential. Leadership expertise as a successful leader in a strategic multifunctional setting, with a strong understanding of implementing change and people agility.
- Excellent business judgment and critical thinking skills.
- Proven process characterization and validation experience.
- Practical experience with manufacturing process technology transfer.
- CGMPs, regulatory guidelines, validation processes, and other applicable regulatory requirements are all knowledgeable.
- Outstanding interpersonal communication and presenting abilities