Under minimal supervision, the TEMP Scientist, Downstream Process Development sits within the protein purification group and is responsible for developing recovery and purification process operations for recombinant proteins. Primary responsibilities include bench and pilot scale process development activities; data documentation; and participating in the technology transfer to manufacturing facilities.
ESSENTIAL DUTIES AND PRIMARY RESPONSIBILITIES
- Experience in affinity, ion-exchange, hydrophobic interaction and mixed-mode chromatography techniques
- Statistical experimental design and analysis (JMP experience preferred)
- Develops experimental protocols, executes laboratory experiments and authors reports in accordance with Good Documentation Practice and scientific principles
- Scientifically characterizes drug substance and/or drug product manufacturing processes
- Proactively troubleshoots and mitigates complex technical issues associated with primary recovery, chromatography processes and formulation
- Authors technical detailed development reports and provides input/data for manufacturing documents and regulatory submissions
- Individual contributor and subject matter expert in ongoing late-stage process characterization activities
- Collaborates effectively to achieve results as an individual as well as through others
- Actively creates, generates, and presents experimental designs, plans, and data summaries
- With minimal supervision, generates and delivers concise/clear technical presentations to management
- Ensures laboratory Safety practices/goals are followed and achieved
JOB SKILLS, ABILITIES AND QUALIIFICATIONS
- BS in Physical, Chemical or Biological Sciences or Engineering or other applicable field
- or BS ≥ 8 years of relevant experience w/a minimum of 5 years of industry experience
- or MS ≥ 5 years of relevant experience w/a minimum of 3 years of industry experience
- or PhD ≥ 2 years of relevant industry experience
- Experience in product recovery/clarification, chromatography, filtration, PAT, and high throughput screening (HTS) technologies
- Experience with AKTA chromatography systems and Unicorn software, as well as filtration methods including normal flow and TFF
- Scientific understanding of current purification technologies, as well as the ability to explore and develop novel approaches to further advance innovative purification technologies
- Exceptional organizational skills
- Proven working knowledge of GDP, GLP & cGMP compliance and ISO9000
- Fluent in practical application of PC’s, Microsoft Project, Word, Excel, PowerPoint as well as statistical experimental design and analysis software (e.g., JMP)
- Ability to travel up to 25% (US and Internationally)
- Ability to work flexible work schedules.
- Proven ability to work in a lean organization and creatively tackle problems.
- Work independently in a matrix environment and manage multiple tasks simultaneously.
- Experience in process characterization within a biosimilar process development organization
- Working knowledge of U.S. Government-funded programs is preferred
Contact: Daniel Yun | [Click Here to Email Your Resumé]