Our cell culture development team in St. Louis MO is looking for a talented and experienced Principal Scientist to join our upstream group. This position will be responsible for leading projects such as media/feed optimization, bioreactor process development and process characterization. A person in this role is expected to lead projects, troubleshoot technical challenges, apply new technologies and interact frequently with customers. Additionally, this person is expected to mentor the activities of junior staff and will have approximately 4 direct reports.
This position requires excellent interpersonal and presentation skills with demonstrated ability to present effectively in client meetings and reports. The candidate should be self-sufficient in planning and executing daily activities and able to troubleshoot technical challenges and apply innovative technology to improve efficiency.
- Act as a lead upstream scientist on multiple programs having project oversight and direct and indirect report management responsibilities.
- Plan project scope, timing and resource requirements.
- Design and develop mammalian cell culture processes to support the production and manufacturing of recombinant proteins (including mAbs) with activities including:
- Clone and media/feed screening using AMBR technology
- Bioreactor culture development including fed-batch, perfusion and XD® technologies (2 to 50L scale) with both glass and single use cell culture technologies.
- Design experimental plans based on the defined deliverables, planning the activities to meet the project timelines by working closely with project managers.
- Lead the transfer of developed upstream processes to the global manufacturing network including documentation and technical know-how.
- Write, revise and approve process development reports and technology transfer protocols.
- Attend project-team meetings. Present and discuss the data and project progress at those meetings.
- Stay current with relevant technologies and be able to identify and justify new equipment needs.
PhD in biology, cell biology, biochemistry, chemical/biomolecular engineering, or equivalent science discipline.
- At least 5 years of relevant biopharmaceutical industry experience.
- Upstream bioprocessing experience utilizing mammalian cell cultures; experienced in designing and optimizing cell culture processes with manufacturing in mind
- Demonstrated experience working with fed-batch and/or perfusion bioreactors. Expertise with Sartorius (including MFCS) and/or Finesse bioreactor control systems preferred.
- Prior experience with direct reports in a supervisory role
- Experience using design of experiments (DOE) software (i.e.MiniTab, JMP) preferred.
- Strong knowledge of GMP regulations in cGMP manufacturing environment.
- Excellent problem solving and critical thinking skills.
- Excellent writing, communication and presentation skills.
- Strong MS Excel, PowerPoint and Word skills. Microsoft Project skills preferred.
- Excellent organization and planning skills.
- Strong attention to detail and ability to adhere to standards procedures.
- Ability to drive functional, technical and operational excellence.
- Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.
- Ability to design complex studies based on the deliverables.
- Ability to analyze and summarize complex scientific data.
- Ability to author reports, procedures, and other documents.
- Ability to function in a rapidly changing environment.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to make and communicate complex decisions.
- Ability to speak effectively before groups of customers and employees.
- Ability to apply complex mathematical concepts to physical problems in areas such as heat and mass transport.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Lift objects up to 50 lbs. occasionally. Stand up to 20% daily. Walk within lab and between buildings daily. Repetitive hand motions.