Staff Scientist, Analytical for Protein Development and Clinical Manufacturing

Job Description

Scientific Direct Hire Jan 5, 2024 Company Profile Our client is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. Their lead candidate is a 24-valent, broad-spectrum, carrier-sparing pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease (IPD). The Company is re-engineering the way highly complex immunizations are made through modern synthetic techniques, including advanced chemistry and our exclusively licensed XpressCFTM cell-free protein synthesis platform. The Company is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. Summary Our client is looking for a highly skilled, motivated, and creative analytical scientist to join Vaccine Product Development organization as staff scientist within Protein Development and Clinical Manufacturing. The primary function of this senior position is to lead efforts for the analytical development and method qualification for measuring tier, impurities, and product quality for in-process intermediates. This position will lead the strategy for measuring the attributes needed for successful process characterization and validation of the protein manufacturing processes. The successful candidate will also manage staff from scientists to research associates and provide scientific mentorship and technical guidance to members of the protein team. Essential Functions Provide strategic, tactical, and technical leadership in the development of analytical methods supporting protein manufacturing processes. Work with the protein development team to understand the manufacturing processes and determine the best methods to measure needed quality attributes. Provide strategy and technical leadership for developing the method qualification approach for assays used for process characterization. Provide technical direction, mentorship and coaching to the protein team on analytical approaches and technologies. Partner with CDMOs to transfer assays as needed to support process validation activities at CDMOs. Collaborate with the AD/QC team to ensure alignment and best use of resources. Survey new analytical technologies and advise on most powerful analytical technologies. Work with lab automation to create high throughput methods leveraging liquid handling and robotic technologies. Author technical reports for regulatory submissions. Manage 1-3 direct reports. Requirements PhD in Chemistry, Analytical Chemistry, Biochemistry, or related field with 8+ years relevant industry experience; MS or BS with 15+ years of industry experience in Pharma / Biotech industry required. Outstanding collaboration skills and ability to work across disciplines. Must be a strong scientific leader who can guide scientists with clear goals of developing analytical methods, and critically and skillfully review and assess analytical methods under development. May need to provide direction for troubleshooting various issues during method development. Scientific creativity and curiosity with the ability to apply new technologies to complex analytical challenges. Proven track record of analytical development leadership for biologics. Extensive expertise in U/HPLC, CE, enzymatic assays, and impurity assays. Excellent technical writing skills and experience authoring development reports, SOPs, regulatory filings, or other documents. Strong written and verbal communication skills, and efficient in communicating in inter-disciplinary and cross-functional teams. Experience managing direct reports and developing young scientists. All employees require vaccination against COVID-19. Reports to: Associate Director, Downstream Development for Protein Development and Manufacturing Show more Show less