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
As a member of the Analytical Development team at our clinical-stage vaccine innovation company, your primary responsibility will be to support the developmental activities in the laboratory. You will have the opportunity to assist in the design, execution, and interpretation of experiments to analyze drug substances and intermediates, including proteins and carbohydrates. Your key responsibilities will include: - Performing microplate assays, including enzymatic assays - Utilizing HPLC techniques, especially SEC and RP-HPLC with experience in Chemstation - Working with CE and iCIEF, especially with Protein Simple or PA-800 systems - Assisting in analytical method development of new assays - Maintaining accurate and detailed records of experiments - Summarizing data and communicating effectively with the analytical team - Supporting daily lab operations, sample inventory, and sample shipment - Collaborating within a team environment to achieve team objectives - Completing assigned tasks with high quality and in a timely manner To qualify for this role, you should have a BS in Chemistry, Analytical Chemistry preferred, Organic/Biochemistry considered, with 2-6 years of relevant industry experience or an MS with 1-4 years. The ideal candidate will possess a background in analytical chemistry principles and hands-on experience with modern analytical instruments commonly used in the analysis and characterization of drug candidates. Candidates with other scientific disciplines may also be considered based on relevant experience. Additionally, you should have: - Experience in chemical and biological assays such as colorimetric/fluorimetric microplate assays and HPLC - Proficiency in working with protein analysis (UV-Vis, CE, BCAs, etc.) - Familiarity with carbohydrate analysis and SEC-MALS is a plus - Understanding of basic principles of analytical method development/validation/qualification concepts - Attention to detail, excellent record-keeping/documentation skills, and strong analytical abilities - Strong interpersonal skills, effective communication both verbally and in written formats - Ability to work independently and collaboratively in a fast-paced, cross-functional environment - Eagerness and ability to learn and understand new concepts with ease Please note that all employees are required to be vaccinated against COVID-19. This position will report to the Scientist II, Analytical Development and is based in San Carlos, CA. The compensation package for this role is competitive and includes comprehensive benefits along with an equity component. The salary range for this position is $106,000 - $115,000.,
As a highly skilled and motivated analytical scientist, you will join the Vaccine Product Development organization as a staff scientist within Protein Development and Clinical Manufacturing at our client's vaccine innovation company. Your primary role will be to lead efforts in analytical development and method qualification for measuring tier, impurities, and product quality for in-process intermediates. Additionally, you will strategize the measurement of attributes crucial for successful process characterization and validation in protein manufacturing processes. Your responsibilities will also include managing a team of scientists and research associates, providing scientific mentorship, and technical guidance within the protein team. **Key Responsibilities:** - Provide strategic, tactical, and technical leadership in developing analytical methods for protein manufacturing processes. - Collaborate with the protein development team to determine optimal methods for measuring quality attributes. - Lead the development of the method qualification approach for assays essential for process characterization. - Mentor and coach the protein team on analytical approaches and technologies. - Coordinate with CDMOs to transfer assays as required for process validation. - Liaise with the AD/QC team to ensure resource alignment and efficiency. - Explore new analytical technologies and recommend the most suitable ones. - Develop high throughput methods using lab automation tools such as liquid handling and robotics. - Prepare technical reports for regulatory submissions. - Supervise 1-3 direct reports. **Qualifications Required:** - PhD in Chemistry, Analytical Chemistry, Biochemistry, or related field with 8+ years of industry experience; or MS/BS with 15+ years of experience in Pharma/Biotech industry. - Exceptional collaboration skills and ability to work across different disciplines. - Strong scientific leadership to guide the team in developing and reviewing analytical methods. - Demonstrated scientific creativity in solving complex analytical challenges. - Proven track record in analytical development leadership for biologics. - Proficiency in U/HPLC, CE, enzymatic assays, and impurity assays. - Excellent technical writing skills for development reports, SOPs, regulatory filings, etc. - Effective written and verbal communication skills for cross-functional team interactions. - Experience in managing direct reports and nurturing young scientists. - Mandatory COVID-19 vaccination for all employees. By joining our client's company, you will be part of a team dedicated to eradicating or treating invasive bacterial infections through innovative vaccine development. Your role will be crucial in ensuring the quality and efficacy of protein manufacturing processes to protect humankind from bacterial diseases.,