AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.
This is a Principal Development Scientist position in the Upstream Process Development group. Primary responsibilities include upstream process characterization, process development for GMP manufacturing, client management and technology development.
- Coordinate upstream development activities leading to clinical and commercial manufacturing for multiple client projects.
- Work with clients and internal project teams in the successful completion of contract manufacturing projects.
- Present data at client project teams and written reports.
- Take a leadership role within the department for developing upstream processes:
- Develop, coordinate, and communicate experimental plans within the department.
- Execute and manage DoE shake flask and bench scale bioreactor experiments.
- Manage large data sets and provide technical guidance to others in the analysis and interpretation of data.
- Write development protocols and characterization reports.
- Coordinate activities and experiments with project management, manufacturing, purification development, and analytical development.
- Provide technical support to manufacturing during large scale manufacturing campaigns.
- Contribute to the overall operation of the lab and infrastructure improvements
- Provide technical support in the laboratory as necessary.
- Implementation of new equipment and technology.
- Provide technical and strategic planning support to business development activities with respect to new client projects and new business initiatives.
KNOWLEDGE, SKILLS & ABILITIES:
- Background in upstream process characterization.
- Extensive Management experience of a scientific staff.
- Excellent technical writing and presentation skills.
- PhD. in a life science or engineering with 12+ years of relevant experience or equivalent BS/MS experience.
- Demonstrated experience in a mammalian cell culture and bioreactor lab environment.
- Previous supervisory, technical guidance and leadership experience.
- Previous experience with process validation activities and knowledge of large scale manufacturing activities in a GMP environment.
- Experience with JMP or other statistical analysis tools would be beneficial.
- Equivalent education and experience may substitute for stated requirements.
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.