Sr. Project Manager, Global External Manufacturing

BioSpace

Novato (CA)

Hybrid

USD 120,000 - 180,000

Full time

14 days+

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Job summary

BioMarin seeks a Senior Project Manager to lead end-to-end delivery across GEO site projects and the global external manufacturing network in a highly regulated GMP environment. You will translate complex inputs into credible plans, manage CMOs, and drive schedules and governance.

Responsibilities include building integrated project schedules, coordinating technical transfers, validations, and supply continuity, while ensuring documentation meets GMP and inspection readiness, and maintaining

Qualifications

  • Bachelor’s degree in Engineering/Science, Business, or Information Systems (or equivalent experience).
  • PMP certification preferred.
  • Lean Six Sigma Green Belt or higher preferred.
  • Minimum 5 years’ experience in project management or business process improvement within a GMP-regulated manufacturing environment.
  • Experience delivering or supporting technical transfers, validations, engineering changes, or portfolio projects.
  • Experience in external/contract manufacturing is an advantage.

Responsibilities

  • Lead end-to-end project delivery across GEO site and external manufacturing network.
  • Create and maintain integrated project schedules with milestones and dependencies.
  • Interface with CMOs to align deliverables and timelines.
  • Support technical transfers, validation, quality and supply continuity initiatives.
  • Ensure documentation and change control meet GMP expectations and inspection readiness.
  • Drive governance, risk, and decision logs across projects.

Skills

Project management
Cross-functional work
GMP awareness
Scheduling
MS Project
Power BI
Stakeholder engagement
Communication

Education

Bachelor’s degree (Engineering/Science/Business/IS)
PMP certification
Lean Six Sigma Green Belt

Tools

MS Project
Power BI

Job description

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well‑understood biology and provide an opportunity to be first‑to‑market or offer a substantial benefit over existing therapeutic options.

About Technical Operations

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting‑edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Sr. Project Manager, Global External Manufacturing

Hybrid - Novato, CA 2 Days On Site

Role Purpose

The Senior Project Manager drives disciplined, end-to-end project delivery across the GEO site portfolio and the global external manufacturing network, ensuring projects are planned, governed, and executed against approved scope, cost, and schedule in a highly regulated environment. This role is accountable for independently building and maintaining integrated, logic driven project schedules, governing execution, and enabling timely, data driven decisions across new product introductions and continuous improvement initiatives. The Senior Project Manager serves as the critical link between portfolio planning and execution teams by translating complex technical and operational inputs into credible plans, clear tradeoffs, and actionable insights that support reliable delivery across GEO.

Key Accountabilities
Project & Portfolio Management
  • Experience in project management of tech transfers, merger & aquisition-integrations required
  • Manage assigned projects through the full lifecycle, from intake and approval through execution, handover, and benefits realization.
  • Establish and maintain project charters, RAID logs, decision logs, and governance artifacts to ensure transparent, consistent, and audit‑ready oversight.
  • Ensure project scope, prioritization, and objectives remain aligned with strategic, operational, compliance, and capacity requirements across GEO.
  • Prepare and present concise, decision‑focused project reviews that synthesize progress, risks, issues, and required decisions for governance forums.
  • Lead and support continuous improvement initiatives by identifying recurring execution pain points, inefficiencies, and failure modes across projects, and partnering with stakeholders to improve processes, governance, and digital ways of working across GEO.
Project Planning & Schedule Ownership
  • Independently build, maintain, and optimize integrated project schedules using approved digital project management tools (e.g., MS Project or equivalent), including logic ties, milestones, dependencies, and critical paths.
  • Translate technical, quality, validation, and manufacturing inputs into credible, execution‑ready timelines, in partnership with SMEs.
  • Continuously analyze schedule health to identify drivers of slippage, downstream impacts, compression opportunities, and mitigation strategies.
  • Use schedule data to proactively surface risks, tradeoffs, and decision points for functional leaders and governance forums.
External Manufacturing (CMO) Project Delivery
  • Act as the structured project interface with CMOs to align deliverables, timelines, resource needs, and approval pathways.
  • Integrate CMO activities into end‑to‑end project schedules, ensuring external dependencies are logically linked and actively managed.
  • Support technical transfer, validation, quality, engineering, and supply continuity initiatives with internal and external teams.
  • Ensure documentation, change control, and execution activities meet GMP expectations and are inspection‑ready execution activities meet GMP expectations and are inspection ready.
Integration & Decision Support
  • Consolidate schedule, risk, and capacity data across projects to proactively surface decision needs and escalation items.
  • Explain not only what is happening, but why—clearly articulating root causes, leading indicators, and implications for scope, schedule, and resources.
  • Maintain decision logs ensuring actions, owners, and due dates are captured, tracked, and closed.
Resource, Risk & Dependency Management
  • Balance project resource demands with operational constraints, surfacing capacity conflicts, and dependency risks for timely escalation.
  • Maintain integrated views of critical paths, interdependencies, and mitigation actions across internal teams and CMOs.
  • Enforce disciplined risk management and change control to protect approved scope, schedule, and compliance commitments.
Stakeholder Engagement & Digital
  • Drive cross-functional alignment by setting clear expectations, resolving execution issues, and escalating risks that threaten delivery.
  • Prepare and deliver concise, decision‑focused project updates to the Head of Strategy and Business Operations and senior stakeholders.
  • Support the evolution and consistent application of governance forums, standards, and ways of working to enable reliable execution, effective escalation, and cross-functional alignment across GEO.
  • Enable digital and data enabled ways of working by applying PMO standards, dashboards, and analytics to improve visibility, predictability, and governance effectiveness.
Qualifications
Education
  • Bachelor’s degree in Engineering/Science, Business, or Information Systems (or equivalent experience).
  • Project Management Profession (PMP) certification preferred
  • Lean Six Sigma Green Belt or higher preferred
Experience
  • Minimum 5 years’ experience in project management or business process improvement within a GMP-regulated manufacturing environment.
  • Proven experience independently building and managing complex project schedules with cross‑functional and external dependencies
  • Experience delivering or supporting technical transfers, validations, engineering changes, or portfolio projects.
  • Experience in external/contract manufacturing is an advantage.
Skills & Competencies
  • Exceptional communication skills with the ability to tailor messages for technical teams, operational leaders, and senior executives while maintaining clarity and alignment.
  • Demonstrates strong organizational awareness; understands decision‑making dynamics and navigates matrixed environments effectively.
  • Influences and mobilizes cross-functional teams without direct authority through credibility, strong relationships, sound judgment, and consistent delivery.
  • Skilled in conflict management, facilitating difficult conversations and guiding teams toward constructive resolution.
  • Understanding of biopharma operations and compliance requirements.
  • Financial/business acumen with disciplined governance oversight.
  • Advanced digital literacy, demonstrated through hands‑on use of modern project management, analytics, and AI‑enabled tools to independently build and maintain integrated schedules, model dependencies and critical paths, analyze delivery risk, and translate data into decision‑ready insights (e.g., MS Project, Power BI, or equivalent).
Workstyle & Travel
  • Hybrid working model; travel to external partners as required (10–20%).

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

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, or protected veteran status and will not be discriminated against on the basis of disability.

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