Scientist II/Sr. Scientist - Cell Culture
A leader in the development and discovery of inventive medicines that utilize our next generation antibody-based technologies. Our team of 250+ devoted individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various infectious diseases and autoimmune disorders. Our platforms and products have attracted multiple partnerships with industry leading pharmaceutical companies around the world.
Summary of Position:
The Scientist II/Sr. Scientist is a technical leader responsible for early-stage and late-stage cell culture process development and optimization, as well as late-stage process characterization, validation and commercial manufacturing support. This key team member is responsible for developing process control strategies for our pipeline molecules in collaboration with manufacturing, validation, quality and regulatory functions. He/she will work also closely with other development functions, including purification, analytical, and formulation teams, to support development of clinical and commercial cell culture processes. He/she will be responsible for the design, execution, and analysis of experiments and for providing interpretations and conclusions in technical reports in a timely fashion. This individual will also be responsible for providing technical support to other groups and leadership teams, and for supervising and mentoring direct report(s) to support these activities.
Responsibilities and Job Duties:
- Leads early-stage pipeline programs, including process development, scale-up, toxicology material production, raw materials strategies, tech transfer, clinical material manufacturing support, platform development and regulatory submissions, and support to commercial manufacturing.
- Develops strategic goals and spearhead efforts for late-stage process development strategies, including the design, planning, and execution of process characterization and small- and large-scale process validation studies.
- Leads the technology transfer of cell culture processes to GMP manufacturing. Provides continuous support to manufacturing throughout the product life cycle including continuous improvement projects, campaign monitoring, data analysis and regulatory support.
- Authors sections of regulatory documents such as INDs, BLAs, and other documents including protocols and technical reports, in collaboration with the development, quality, and regulatory groups to support regulatory filings and commercialization projects.
- Oversees the operation and maintenance of equipment and instruments and implement best practices as part of robust process development strategy and technology transfer to manufacturing.
- Leads the use of the team's innovation skills to develop and implement continuous improvement projects.
- Provides leadership to ensure all work is performed in a compliant manner to meet safety procedures and applicable regulatory guidelines and work to continuously improve safety and lab procedures.
- Presents scientific findings at internal and external meetings and champion scientific journal publications.
- Serves as a resource for the department and project teams, proactively keeping colleagues updated with current scientific trends and technical aspects from conferences, local meetings, and the literature.
- Performs all supervisory responsibilities for direct report(s) who support these activities. Provides coaching and mentoring to ensure staff development and feedback to maximize productivity and effectiveness.
- Bachelor's degree in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 10 years of related experience, at least 8 of which in the biotech or pharmaceutical industry in a similar role
- PhD or Master's degree in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 6 years of related experience with at least 4 years of industry experience in early to late stage process development of biological molecules
- Hands-on experience with bench to intermediate scale-single use bioreactors, design of experiments and development of high-titer cell culture processes.
- Process scale-up or media development experience
- Late-stage CMC experience, including process characterization, validation and commercialization including document authoring.
- Experience with early and late-stage cell culture process development activities and process characterization for cell culture unit operations