$150K — $200K *
Serves as a subject matter expert in upstream process development areas, e.g cell culture, transfection, bioreactor operations
Responsible for leading process development activities for next generation platform development
Design, direct and execute studies aimed at deepening scientific understanding of process impacts on product quality attributes
Responsible for writing/reviewing experimental plans, protocols, reports and managing experimental timelines to meet corporate goals
Point person for reviewing, and summarizing data via technical reports, batch records, etc. and presenting scientific data
Mentor and guide associate scientists in the design and execution of their work and careers
Leads cross functional teams consisting of biology/biochemistry, chemistry, cellular engineering or viral vector backgrounds to implement changes and improvements.
Leads or assists in technology transfer from Development to GMP Manufacturing and provides on the floor support to GMP manufacturing
BS with 13+ years of directly related experience or MS with 8+ years of directly related experience, or PhD with 3+ years of experience in upstream process development.
Degree emphasis in Chemical Engineering, Biochemistry, Bioengineering, Biology, or related field preferred.
An in-depth understanding of the fundamentals of the area of expertise for the production of biologics or more specifically viral vectors.
Familiarity with mammalian cell culture and bioreactor systems required.
Good scientific aptitude allowing formulation of hypothesis, design and execution of experiments, data analysis and sound scientific conclusions and ability to present findings to varied audiences.
Experience with multiple scales of bioreactors, control software, and process analytical technology is desired.
Familiarity of analytical methods for biologics or vaccine development preferred.
Experience with high-throughput process development techniques, statistical design of experiment (DoE) and statistical analysis using JMP or other software is preferred.
Ability to conduct laboratory experiments while complying to safe work environment and good laboratory notebook practices.
Knowledge of GMP/ICH/FDA regulations preferred.
Ability to work in a collaborative team environment and to adapt to changing priorities.
Experience managing or mentoring associate scientists is preferred.
Experience in working with and managing outside vendors.
Valid through: 12/9/2020
$80K — $100K
3 days ago
$80K — $100K