Senior Director/Vice President, Site Operations at Dendreon Corporation

Seal Beach, California, United States -

Full Time

Start Date

Immediate

Expiry Date

28 Apr, 26

Salary

0.0

Posted On

28 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Leadership, Strategic Planning, Team Development, Change Management, Collaborative Problem-Solving, cGMP Compliance, Quality Systems, Aseptic Processing, EHS&S Regulations, Business Acumen, Data-Driven Decision Making, Regulatory Inspections, Operational Metrics, Performance Improvements, Cross-Functional Collaboration, Talent Management

Industry

Biotechnology Research

Description

Overview Who We Are: At Dendreon, we’re transforming the battle against cancer with personalized immunotherapy. Our flagship product, PROVENGE® (sipuleucel-T), was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient’s own immune cells to fight the disease. If you’re driven by the opportunity to make a meaningful impact on cancer patients' lives, we invite you to join our team. With Immunotherapy Manufacturing Facilities in Seal Beach, CA, and Union City, GA, a strong Research & Development group in Seattle, WA, and a highly skilled Commercial team across the nation, Dendreon is at the forefront of cancer treatment innovation. Core Values: Put Patients First: Every day is an opportunity to improve the lives of those living with cancer. Act with Integrity: We commit to transparency, honesty, and always doing what’s right. Build Trust: Trust is earned through candid, open communication and a collaborative approach. Raise the Bar: We embrace continuous improvement and innovation, always striving to elevate our people. Drive Results: We are accountable to each other and deliver success together. Your Role: 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. 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. Scope: Leads or participates with cross-functional and cross-site teams in the development and implementation of policies, procedures and practices associated with all aspects of an FDA licensed drug product. Avoids erroneous decisions that could have a longer-term effect on the company’s success. Working knowledge of cGMP’s, quality systems, aseptic processing and the numerous EHS&S regulations (e.g., EPA and OSHA) Able to assess IMF capabilities and capacities and develop plans to solve problems / improve performance. Provides leadership, directs and controls the activities of multiple functional areas or services groups. Interact with directors and senior managers in various functional areas and/or groups at multiple sites. Able to interact with associates, senior and executive management, and vendors. Recognized in the organization as an influential leader. Responsible for managing the talent in their organization to ensure the success for their functional areas. Identifies problems and leads team to resolution. Escalates issues to executive leadership as appropriate. Able to work with abstract ideas or ambiguous situations. Effective at organizing and prioritizing a range of projects. Plays role in corporate development of methods, techniques and evaluation criteria for projects, programs and people. Qualifications Job 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. Working Conditions and Physical Requirements: On-site 5 days a week in our Seal Beach, CA office (NOT remote) Travel will be required. Job performed in a lab, office, or utility (noisy) environment Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.

Responsibilities

The Senior Director or Vice President of Site Operations leads PROVENGE manufacturing and oversees U.S. site operations to align with product objectives. This role involves managing technical operations, ensuring compliance with cGMP guidelines, and enhancing overall business performance.