Staff Engineer, Drug Substance, MSAT in Raron

pVaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. /p pbWHAT /bwe do is every bit as important asbHOW /bwe do it!Our work together is guided by four enduring core values: /p ulliRETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered. /liliAIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. /liliLEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives. /liliMODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making. /li /ul h3bSummary: /b /h3 pVaxcyte is looking for an energetic and talented individual to join the Manufacturing Science and Technology (MSAT) team in the role of Drug Substance (DS) Staff Engineer. The incumbent will support the conjugation manufacturing operations from commercial readiness through PPQ and ongoing commercial production, onsite at contract manufacturing organizations (CMO), with the primary responsibility to provide technical and operational support of manufacturing operations that ensure robust and efficient manufacturing processes. This position will primarily be located in Visp, Switzerland. /p pThis position will require the candidate to manage the highly complex conjugation manufacturing processes for Vaxcyte’s vaccine portfolio. This is an exciting opportunity to join an outstanding team, with a mission to support late-stage clinical manufacture, launch, and commercial operations for the PCV franchise. The successful candidate will have the following skills and qualities: /p ulliA skilled process engineer with expertise in:ulliMolecule activation and bioconjugation (e.g., activation chemistries, conjugation reaction kinetics, in-process controls, and common side reactions/impurities) /liliStrong quantitative skills: trend and multivariate analysis of process and analytical data to support continued process verification (CPV), deviation investigations, and process characterization (e.g., DOE). /li /ul /liliAn exceptional team player who works seamlessly with others, speaks up, and remains focused on achieving the best results to attain company goals. /liliThe ability to analyze data and communicate conclusions, decisions and recommendations concisely to key stakeholders. /liliA strong sense of ownership and accountability; commitment to Vaxcyte’s mission of protecting humankind. /li /ul h3bEssential Functions: /b /h3 ulliWork cross functionally with program management, process development, quality, facilities, regulatory, finance, logistics, clinical supply, and CMO / supplier management to ensure manufacture under GMP of different protein-polysaccharide conjugate Drug Substances required for Vaxcyte’s vaccine portfolio. /liliExecute statistical thinking and data analysis using: DOE planning/analysis, process capability, control charts/CPV trending, and clear data visualization; proficiency with common tools. /liliOversight of CMO service provider(s) to ensure delivery of commercial readiness, process validation, and commercial stage manufacturing campaigns. /liliEnable MSAT DS team participation in technology transfer, equipment/technology procurement and qualification, late-stage process characterization, process validation, and deviation and deficiency investigations and troubleshooting. /liliLead all aspects of and engage in the planning, design, execution, and documentation of DS manufacturing process Investigations and CAPAs. /liliDrive continuous improvement and change management in DS manufacturing processes through technological innovation and application of first principles in process engineering. /liliSupport the process to select new CMOs and suppliers. /liliLeverage literature, industry/regulatory guidance, and practical experience to perform work and influence CMC strategies. /liliRecommend and implement new technology that advances knowledge and productivity within the department. Drive continuous improvement. /liliAuthor and review technical reports, manufacturing documents, regulatory submissions, and publications. /liliPresent at department, project team, and senior management meetings. May present externally at scientific conferences. /liliSupport the CMOs during inspections of health authorities where necessary and ensure proper follow-up of any potential observation or recommendation. /li /ul h3bRequirements: /b /h3 ulliPhD in Bio/Chemical Engineering or Microbiology/Chemistry/Biochemistry with 9+ years of relevant Pharma/Biotech industry experience, or Master’s degree in Bio/Chemical Engineering or Microbiology/Chemistry/ Biochemistry with 12+ years of relevant Pharma/Biotech industry experience. Other combinations of education and/or experience may be considered. /liliDemonstrated capability in statistical thinking and data analysis: DOE planning/analysis, process capability, control charts/CPV trending, and clear data visualization; proficiency with common tools. /liliExperience with Vaccine manufacturing operations preferred. /liliStrong experience in Drug Substance Manufacturing under GMP regulations required. Understanding of Quality systems. Experience in Drug Substance manufacturing equipment specification and qualification preferred. /liliStrong scientific or technological (process engineering) background and hands-on experience with biochemical reaction, product recovery, and purification processes. Commercial manufacturing experience preferred. /liliDeep knowledge of protein‑polysaccharide conjugation principles (activation/coupling chemistries, reaction kinetics, impurity formation, and linkage distribution), plus understanding of CQAs and analytical characterization relevant to conjugates. /liliSound knowledge of product recovery unit operations such as homogenization/microfluidization, centrifugation, and depth filtration product purification unit operations such as chromatography, UF/DF TFF, and precipitation process analytics/control systems. /liliStrong ability in troubleshooting equipment/technology and process. Adept at FMEA. Excellent analytic skills. Experience in Investigations and development and implementation of CAPAs preferred. /liliExperience with facility fit assessment, facility start-up, technology transfer, process validation, and scale-down studies implementing DOE desired. /liliStrong interpersonal and leadership skills. Ability to communicate effectively both verbally and in written formats. Experience with Cross-Functional teams and managing direct reports. /liliProven technical leadership skills including strong project management skills. /liliFluency in spoken and written English is highly preferred. /li /ul pbReports to: /bAssociate Director, MSAT Bioconjugates /p pbWork Arrangement: /bOnsite /p pbCompensation: /b /p pThe compensation package will be competitive and includes an equity component. /p pbRelocation: /b /p pThis role is not eligible for relocation assistance. /p pWe are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. /p h3Voluntary Self-Identification /h3 pFor government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. /p pAs set forth in Vaxcyte’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. /p pIf you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: /p pA "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. /p pA "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval or air service. /p pAn "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. /p pAn "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. /p #J-18808-Ljbffr