Senior Director/Vice President, Site Operations

Dendreon PharmaceuticalsSeal Beach, CA
38dOnsite

About The Position

The Senior Director or Vice President of Site Operations is responsible for leading PROVENGE manufacturing at Dendreon’s commercial immunotherapy facilities. This strategic role provides oversight and direction across U.S. site operations to ensure alignment with product and project objectives, while working collaboratively with the Operations Leadership Team to meet production goals, uphold quality standards, and enhance overall business performance. The position defines and drives the strategic and operational direction of manufacturing and support functions, including planning, implementation, and continuous improvement of processes. The ideal candidate is a strong, influential leader capable of guiding directors and senior managers across multiple functional areas to deliver results and advance organizational goals.

Requirements

  • Bachelor’s degree in Life Sciences, Engineering, or a related field required; an advanced degree (MS, MBA, or PhD) is strongly preferred.
  • At least 7-10 years in leadership roles, managing cross-functional teams and multi-site operations.
  • Proven experience leading large-scale operational initiatives, managing complex technical programs, and guiding senior-level teams in a regulated environment.
  • Demonstrated success in meeting and sustaining operational metrics, implementing performance improvements, and managing cost of goods (COGS) or department/site budgets.
  • Strong business acumen, with the ability to apply business analytics and strategic insights to prioritize, influence, and make data-driven decisions.
  • Experience supporting regulatory inspections and audits (e.g., FDA, EMA) and working with external manufacturing partners (CMOs/CDMOs) is highly desirable.
  • Working knowledge of cGMPs, aseptic processing, quality systems, and EHS&S regulations (OSHA, EPA), with the ability to evaluate and implement new technologies within the regulatory landscape.
  • Skilled in inspirational leadership, strategic planning, team development, change management, and collaborative problem-solving.
  • Excellent communication, facilitation, and presentation skills; comfortable engaging with senior executives, regulators, and cross-functional stakeholders.
  • Ability to thrive in dynamic, fast-paced environments and effectively navigate ambiguity and abstract concepts.
  • 10–15 years of progressive experience in the pharmaceutical, biotech, or life sciences industry, with a strong background in cGMP-compliant manufacturing environments.

Responsibilities

  • Ensures the relevant business processes, procedures, and resources are in place to compliantly, safely and effectively produce PROVENGE and other biotech products.
  • Represents technical operations at the Steering Committee level when interfacing with external clients.
  • Manages technical operations at Dendreon’s commercial IMFs (Seal Beach / Union City) and contract manufacturing facilities (CMFs), as appropriate.
  • Leads site EHS&S teams at each Dendreon facility to maintain Dendreon safety standards and align with corporate EHS&S programs.
  • Works collaboratively with cross-functional departments to ensure strict compliance with cGMP guidelines, understanding phase-appropriate requirements for clinical and commercial manufacturing.
  • Interfaces with external customers and FDA during audits and inspections.
  • Develops and achieves both enterprise-wide and site performance goals.
  • Leads metric reviews (manufacturing, safety, engineering, quality, materials, etc) across cross-functional site teams on a regular basis
  • Manages review and adherence to department and site budgets, including COGS
  • Leads and facilitates the planning and execution of a broad range of technical programs and projects as assigned (e.g. Corporate EHS&S, PMO, corporate initiatives, etc).
  • Provides leadership that enhances Dendreon’s culture.
  • Able to coach, develop and retain talent across all levels.
  • Proactively builds cross functional relationships – Apheresis Operations, Technical Operations, Supply Chain, Research and Manufacturing Sciences, Regulatory, etc.
  • Other duties as assigned.
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