Senior Manager, Manufacturing Systems & Operations Readiness (Contractor)

Summary:

As Vaxcyte’s products progress toward late-stage development and commercialization, the Manufacturing organization requires robust digital tools, structured project tracking, and disciplined readiness oversight to support commercial launch preparation and routine GMP manufacturing. This position will support the Manufacturing organization by developing, maintaining, and driving Smartsheet-based trackers, dashboards, action logs, and gap-assessment tools that enable clear visibility into commercial readiness, documentation status, manufacturing campaign preparation, risks, dependencies, and cross-functional deliverables.

Working closely across the Manufacturing team, MSAT, Process Development, Supply Chain, Quality, Regulatory, Project Management, Business Development, and multiple CDMOs/CMOs, this position will help establish structure, transparency, and governance across operational readiness activities. The role will be accountable for supporting readiness gap assessments, tracking closure of actions, consolidating input from stakeholders, monitoring document and campaign readiness, supporting organizational maturation, and preparing clear status updates for Manufacturing leadership. In addition, the role will provide direct support to the Head of Manufacturing with meeting administration, governance routines, team event coordination, and follow-up management. The ideal candidate will combine strong project tracking and digital tool capabilities, particularly Smartsheet, with an understanding of GMP manufacturing operations, commercial readiness, organizational effectiveness, and cross-functional collaboration in a biologics or vaccine manufacturing environment. This position will report to the Executive Director Manufacturing of Vaxcyte Switzerland.

Ideal Candidate Profile:

The ideal candidate is a highly structured manufacturing systems and operations enablement professional with experience in GMP biotech or pharma environments, preferably biologics, vaccines, or external manufacturing. This person does not need to be a deep technical manufacturing expert, but must understand manufacturing operations, documentation, campaign readiness, and CMO/CDMO interfaces well enough to create clarity, structure, visibility, and follow-through across complex cross-functional work.

The strongest candidate will be highly skilled in Smartsheet and digital project tracking, able to build dashboards, trackers, action logs, readiness heatmaps, and reporting tools that translate complex information into clear management visibility. They will serve as an operational backbone for the Manufacturing organization by bringing digital discipline, governance, operating rhythm, meeting discipline, and proactive support to the Head of Manufacturing while helping the function mature its systems, routines, and ways of working.

Essential Functions:

• Establish and Monitor manufacturing campaign readiness, including batch preparation milestones, documentation status, material readiness, open actions, and key decision points.
• Coordinate and consolidate input from Manufacturing, MSAT, Quality, Supply Chain, Regulatory, Project Management, and CDMOs into integrated readiness views.
• Work across the Manufacturing team and with multiple CDMOs/CMOs to create consistent ways of tracking readiness, actions, decisions, risks, dependencies, and deliverables.
• Establish governance routines, readiness meetings, action follow-up, and escalation processes to ensure Manufacturing leadership has clear visibility on readiness status.
• Develop, maintain, and continuously improve Smartsheet-based trackers, dashboards, action logs, and readiness tools to support Manufacturing commercial readiness.
• Support structured commercial readiness gap assessments across manufacturing operations, documentation, campaign preparation, facility readiness, and CDMO deliverables.
• Track readiness actions, owners, due dates, risks, dependencies, and escalation items to ensure timely closure and transparent progress reporting.
• Prepare concise status updates, dashboards, heatmaps, and management reports highlighting progress, gaps, overdue actions, risks, and mitigation options.
• Identify opportunities to improve tracking discipline, data structure, workflow automation, and visual management across Manufacturing readiness activities.
• Support organizational maturation of the Manufacturing function by helping to establish fit-for-purpose processes, governance routines, operating rhythms, templates, trackers, and visual management tools.
• Provide direct support to the Head of Manufacturing for meeting administration, agenda preparation, pre-read coordination, meeting minutes, action tracking, and follow-up management.
• Support planning and coordination of Manufacturing team events, workshops, offsites, governance sessions, and cross-functional alignment meetings to strengthen team effectiveness and operating discipline.
• Support tracking of planned and scheduled manufacturing activities at CDMOs to optimize resource utilization and ensure alignment with commercial readiness milestones.
• Maintain visibility of GMP documentation readiness, including batch records, procedures, protocols, reports, and other manufacturing-related documents required for launch and routine operations.
• Ensure tracking tools support compliance with GMP expectations, quality requirements, safety expectations, and relevant internal governance standards.

Requirements: 

• Bachelor’s or Master’s degree in life sciences, engineering, operations, project management, business administration, or a related field.
• 5+ years of experience in GMP manufacturing, external manufacturing, operations readiness, manufacturing systems, PMO, business operations, or manufacturing support within biotech or pharma.
• Experience in vaccine, biologics, microbial, sterile, or complex large-molecule manufacturing environments.
• Deep Experience supporting commercial readiness, launch preparation, operational readiness, gap assessments, document readiness, manufacturing campaign tracking, or governance routines in a regulated environment.
• Expertise in operational excellence, Lean, visual management, process improvement, or organizational effectiveness practices.
• Advanced hands-on experience with Smartsheet, including trackers, dashboards, reports, automated workflows, action logs, cross-sheet references, and cross-functional project tracking tools.
• Strong digital tool capability and ability to translate complex readiness, documentation, campaign, and stakeholder information into clear, structured, and actionable tracking systems.
• Good understanding of GMP manufacturing operations, batch and campaign readiness, documentation requirements, quality expectations, and cross-functional dependencies.
• Proven ability to work effectively across Manufacturing, MSAT, Quality, Supply Chain, Regulatory, Project Management, and external CDMOs/CMOs, creating alignment, structure, and follow-through across multiple stakeholders.
• Experience supporting organizational maturation, including establishment of governance routines, templates, operating rhythms, process discipline, decision logs, action tracking, and team effectiveness practices.
• Ability to support senior Manufacturing leadership with meeting administration, agenda management, pre-read coordination, minutes, decision logs, action follow-up, workshop preparation, and team event coordination.
• Strong organizational skills, attention to detail, prioritization capability, discretion, and ability to manage multiple workstreams in a fast-paced environment.
• Excellent communication skills with the ability to prepare concise status updates, dashboards, heatmaps, visual summaries, and escalation materials for Manufacturing leadership.
• Experience coordinating workshops, governance meetings, offsites, team events, or operating model improvements in a growing organization.