Scientist, Downstream Processing
BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Sr. Scientist to work for a leading San Diego biotechnology company.
Sr. Scientist, Downstream Processing
The function of the Sr. Scientist, Downstream Processing/Formulation role will serve as a member of the process development/characterization team focused on late-stage characterization of downstream unit operations, prior to process validation. Proficiency in all aspects of chromatography development is required. Competency in clarification techniques, such as continuous centrifugation, depth/membrane filtration is preferred. Position scope extends from bench to pilot-scale activities, DOE execution, data summarization and report generation. Individual technical issue management and effective communication are key position attributes. The candidate will work in a team environment, collaborating with various colleagues in process and product development, and will report to the Director of Product/Process Development.
- Characterization of drug product formulation process
- 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
- BS in Physical, Chemical or Biological Sciences or Engineering or other applicable field: BS with 8 years of relevant experience w/a minimum of 5 years of industry experience or MS with 5 years of relevant experience w/a minimum of 3 years of industry experience or PhD with 2 years of relevant industry experience
- Demonstrated experience in drug product formulation development or characterization
- Experience in design and analysis of stability of drug substance and drug product
- 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 ISO 9000
- 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