Sr. Scientist, Cell Culture Sciences
MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
Summary of Position
The Sr. Scientist is a technical leader responsible for early and late stage process development and optimization, as well as late stage process characterization and validation of cell culture unit operations. This key team member is responsible for developing process control strategies for the pipeline molecules in collaboration with manufacturing, validation, quality and regulatory functions. He/she will work closely with other development functions, including purification, analytical, and formulation teams, to support development of molecules leading to commercialization. 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 the leadership team, and for supervising and mentoring direct report(s) to support these activities.
Responsibilities and Job Duties
- Lead early stage pipeline programs, including process development, scale-up, toxicology material production, raw materials strategies, technology transfer, clinical material manufacturing support, platform development and IND submissions, to support development of molecules leading to commercialization.
- Develop strategic goals and lead efforts for late-stage program commercialization strategies, including the design, planning, and execution of process characterization and small- and large-scale process validation studies.
- Author 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.
- Lead the technology transfer of cell culture processes for GMP manufacturing. Provide continuous support to manufacturing throughout the product life-cycle including continuous improvement projects, campaign monitoring, data analysis and regulatory support.
- Present scientific findings at internal and external meetings and champion scientific journal publications.
- Oversee the operation and maintenance of equipment and instruments and implement best practices as part of robust process development strategy and technology transfer to manufacturing.
- Provide 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.
- Perform all supervisory responsibilities for direct report(s) who support these activities. Provide coaching and mentoring to ensure staff development and feedback to maximize productivity and effectiveness.
- Serve 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.
Education & Experience
- PhD in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 8 years of related experience with at least 5 years of experience in early to late stage process development of biological molecules; or
- Masters’ degree in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 17 years of related experience with at least 10 years of industry experience in early to late stage process development of biological molecules; or
- Bachelors’ degree in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 20 years of related experience, at least 14 of which in the biotech or pharmaceutical industry in a similar role
- At least 5 years of supervisory experience
- Significant hands-on experience with bench to intermediate scale-single use bioreactors, developing high-titer cell culture processes; media development and process scale-up experience
- Extensive late stage experience, including process characterization, validation and commercialization
Knowledge, Skills and Abilities
- Solid understanding of current FDA and ICH guidelines regarding cell culture/drug substance processes to meet regulatory expectations
- Specific knowledge and in-depth understanding of protein expression, 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
- Proven track record of authoring, planning, executing and reviewing both small- and large-scale validation protocols
- Strong understanding of CMC functions
- Ability to collaborate with and influence other functional areas such as Validation and Regulatory Affairs
- Ability to lead, train and mentor staff
- Ability to critically analyze data using statistical tools for process performance to compile technical reports and other documentation
- Strong verbal, presentation and writing skills to communicate effectively internally and externally
- Strong organizational skills and ability to multi-task
- 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
- Ability to work occasional weekends as needed
BioProcess Scientist(s) and/or Associate(s)
MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email firstname.lastname@example.org or call (301) 354-3566 and/or 711 for TTD/TTY service.
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