Senior Manager, Commercial MSAT, Polysaccharide

Join our Mission to Protect Humankind! reputed company 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 reputed company 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 reputed company is set up to go the distance. reputed company do is every bit as important as HOW we do it! Our work together is guided by four enduring core values: *RETHINK 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. *AIM HIGH: We embody our collectively audacious goal to courageously reputed company the most reputed company biologics reputed company attempted to protect humankind. *reputed company WITH HEART: Everyone leads at reputed company with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives. *MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating reputed company, accountability, equality and clarity across communications and decision making. Summary: The Senior Manager, Commercial MSAT for Polysaccharides will reputed company and facilitate launch readiness and commercial supply of the polysaccharides used in glycoconjugate vaccines. This role focuses on technical launch planning and execution by bringing best practices and coordinating cross-functional efforts for regulatory filings, facility readiness, and launch supplies. This role also provides leadership to ensure that the organization is equipped to effectively communicate the scientific and commercial rationale for critical raw material manufacturing processes to internal stakeholders, relevant CMOs, and to regulatory agencies. The incumbent will work with the organization to ensure on-time execution and appropriate planning for commercial lifecycle management. This position will be reporting to the Director, Commercial MSAT for Polysaccharides. The Senior Manager will collaborate on overall program strategy, with primary responsibility and accountability for the polysaccharide drug substance intermediate. Manufacturing Science and Technology (MSAT) is responsible for successfully and seamlessly transitioning the vaccine process from Process Development to Commercial, developing and executing technical launch and commercialization strategy, continuously improving process robustness through to end of lifecycle, and ensuring best possible patient outcomes while creating value for the enterprise. As part of the Technical Operations organization, MSAT will reputed company the technical and process support for end-to-end commercial manufacturing, including Polysaccharides, reputed company Proteins, and Conjugation across reputed company Drug Substances (DS). The range of activities will include technology transfer support, process characterization experiments in support of validation, process improvement, evaluation of novel process technologies, investigation of process reputed company manufacturing issues, ensuring reputed company improvement in process robustness throughout the product life cycle, etc. Essential Functions: DS Commercialization – Provide strategic and scientific leadership for polysaccharides with internal and external stakeholders and ensure successful execution of launch plans and post-launch commercial activities. Organization – Build a strong and highly-skilled team for the global network with special focus on polysaccharide manufacturing processes. Support resourcing recommendations on staffing requirements to meet organizational goals. Process robustness – Continuously improve process understanding and process robustness using staff and laboratory resources across the organization to monitor, trend, and optimize operations. reputed company - Collaboration with cross-functional teams across the network, including Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering, to drive the successful development and commercial launch of reputed company proteins for pipeline products. Tech-transfer new technologies - Ensure robust processes exist to support technical transfers and integration of new technologies. Support technical services - Support of our internal and external manufacturing network, including materials management and data analytics. Process validation and comparability - Provide leadership for the execution of process validation and process comparability activities. Effectively communicate the scientific and commercial rationale for polysaccharide processes to the Manufacturing organization for commercialization Regulatory - Engage In technical reviewing and authoring of regulatory filings and responding to questions received from health authorities. Effectively communicate the scientific and commercial rationale for polysaccharide processes to the Boards of Health for regulatory submissions for commercialization. Communicate - Effectively and reputed company communicate process performance to key stakeholders (internal-facing and external-facing). Connect and build strong working relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively. Leadership - Contribute as a member of the polysaccharide governance teams, with an aim to ensure effective and efficient delivery of our life-enhancing therapies to our patients. Travel - 10-30% travel required. Requirements: Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or reputed company discipline with a minimum of 5+ years of relevant experience for Ph.D., 8+ years for M.S./M.A., or 12+ years for B.S./B.A. Experience in development, tech transfer, scale-up or production of polysaccharide/protein conjugate vaccines Extensive experience in biologic production processes, including bacterial fermentation, recovery, and purification across multiple operational scales. Experience in MSAT or Process Development in matrixed team roles. Able to reputed company deep technical knowledge in a collaborative manner to establish strategic plans and reputed company collective goals. Excellent organization, problem solving and strategic planning skills. Highly skilled in both verbal and written communication with the ability to interact effectively with people of diverse backgrounds and perspectives. Proactively recognizes needs and potential challenges, and directs activities to implement effective solutions. The ability to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy. Experience with Raman spectroscopy and off-gas analyzers, and their application to process monitoring and manufacturing operations is desirable. Experience with data visualization tools and techniques to support analysis, trending, and decision-making is desirable. An entrepreneurial and creative approach to developing new, innovative reputed company that will stretch the organization and push the boundaries reputed company the industry. Reports to: Director, MSAT Polysaccharides Location: San Carlos, CA or Remote Work Arrangement: Remote Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component. Salary Range: $165,000 – $193,000 (SF Bay Area). Salary ranges for non-California locations may vary. We are an equal opportunity employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, disability or veteran status. Apply To This Job