Scientist II - Cell Culture Sciences
Washington, DC, MD
Scientist II - Cell Culture Sciences
The Scientist II is a key team member focused on early and late stage process development and optimization, as well as late stage process characterization and validation of cell culture processes. This individual will be responsible for managing and leading cell culture projects and for solving scientific problems related to robust process development and characterization. This individual will have a crucial role in the design, execution, and analysis of experiments and will provide interpretations and conclusions in technical reports and regulatory filings.
Responsibilities and Job Duties
- Drive and execute activities related to early stage pipeline programs, including process development, scale-up, toxicology material production, raw materials strategies, technology transfer, clinical material manufacturing support, platform development and regulatory submissions, to support development of processes leading to clinical launch, commercialization and improved commercial manufacturing.
- Author and review sections of regulatory filings, protocols and technical reports in collaboration with the development, manufacturing, quality, and regulatory groups.
- Lead and execute late-stage program commercialization projects, including the design, planning, and execution of process characterization and validation studies.
- Support the technology transfer of cell culture processes for GMP manufacturing. Develop continuous improvement projects, implement manufacturing campaign monitoring methods and provide regulatory support through the product life cycle.
- Present scientific findings at internal and external meetings and author scientific journal publications. Integrate new technologies for process development and commercial production.
- Analyze, interpret and present data at group and project meetings, and other scientific forums. Collaborate with internal and external partners to ensure project timelines are met.
- Take an active role in maintaining the laboratory equipment and ensuring a safe working environment.
- Maintain awareness of current scientific trends and technical aspects from conferences, local meetings, and the literature.
Education & Experience Requirements:
- PhD in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 2 years of related experience with at least 1 years’ experience in early to late stage CMC process development for clinical or commercial biopharmaceuticals including document authoring; or
- Masters’ degree in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 11 years of related experience with at least 6 years’ industry experience in early to late stage CMC process development of biological molecules including document authoring; or
- Bachelors’ degree in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 14 years of related experience, at least 10 of which in the biotech or biopharmaceutical industry in a similar role
- Hands-on experience with bench to intermediate scale-single use bioreactors, developing high-titer cell culture processes; media development and process scale-up experience
- Late stage CMC experience, including process characterization, validation and commercialization including document authoring
Knowledge, Skills and Abilities
- Proven ability to solve technical and scientific problems in a collaborative environment
- Strong verbal, presentation and writing skills to communicate effectively internally and externally
- Solid understanding of current FDA and ICH guidelines regarding cell culture drug substance processes to meet regulatory expectations
- Proven track record of authoring, planning, executing and reviewing development and validation protocols and reports
- Specific knowledge and in-depth understanding of cell culture and scale up processes
- Experience with early and late stage cell culture process development activities and process characterization for cell culture unit operations
- Strong understanding of statistical tools and knowledge of DOE and QbD principles. Ability to critically analyze data using statistical tools for process performance to compile technical reports and other documentation
- Ability to collaborate with and influence other functional areas such as Validation and Regulatory Affairs
- Ability to lead, train and mentor staff
- Strong organizational skills and ability to prioritize multiple projects to completion
- Ability to lead cross-functional teams, be collaborative, and represent teams at a variety of forums
- Ability to set-up, maintain, and troubleshoot equipment and drive implementation of new technologies for process development and commercial production
- Willingness to work occasional weekends as needed
May manage a Bioprocess Associate