Sr Director Site Operations - Union City

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:

(Onsite 5 days a week)

The Senior Director, Site Operations is responsible for providing strategic, operational, and tactical leadership across all manufacturing and facilities/engineering functions at the SB or UC Immunotherapy Manufacturing Facility (IMF), including building management, safety and production of PROVENGE and other CMS product lines (if required). This role sets the long-range direction for site’s operations, leads cross-functional collaboration to meet production goals, and ensures compliance with FDA and cGMP regulations. This influential leader will manage and mentor a high-performing team of directors and managers, driving continuous improvement, innovation, and operational excellence.

• Leads overall site operations (PROVENGE and/or CMS) including manufacturing oversight, planning, execution, and performance management across multiple product lines.
• Accountable for contract manufacturing including technical transfer and manufacturing oversight.
• Develop and implement site-wide manufacturing strategy in alignment with corporate goals related to quality, safety, delivery, cost, and employee engagement.
• Lead initiatives focused on operational excellence, lean manufacturing, materials, and process optimization to increase productivity and profitability.
• Establish and maintain a culture of accountability, quality, safety, and continuous improvement using data-driven decision-making and key performance indicators (KPIs).
• Partner closely with cross-functional departments (Quality, Procurement, RMS, Patient Ops) to meet production schedules, ensure compliance, and optimize resources.
• Serve as the primary site operations representative during FDA audits and other external regulatory inspections.
• Develop and manage operating budgets and resource plans; oversee labor, material, and overhead expenses with a focus on cost containment and forecasting.
• Support lifecycle management for all facility infrastructure and production processes, and lead the implementation of new technologies and systems.
• Lead and mentor a team of directors and managers, fostering professional growth, talent development, and succession planning.
• Ensure compliance with cGMP, EHS&S, and OSHA regulations and maintain audit readiness at all times.
• Act as a key member of the Site Leadership Team and represent operations in corporate and strategic initiatives.
• Other duties as assigned.

Scope:

• Provides leadership and direction to multiple functional areas within the site operations organization (Manufacturing, Warehouse and Engineering).
• Develops and implements corporate and site-level policies, procedures, and strategies.
• Recognized as a strategic leader with influence across internal and external stakeholder groups.
• Plays a critical role in identifying and solving complex, abstract challenges impacting long-range operational success.
• Develops and drives policies that shape the company's approach to manufacturing operations and cross-functional collaboration.
• Directly accountable for the performance, compliance, and development of the manufacturing team.

• Bachelor’s degree in a scientific, engineering, or technical discipline (advanced degree preferred).
• Minimum 10+ years of progressive leadership experience in FDA-regulated biotech/biopharmaceutical manufacturing environments.
• Proven success leading large teams and complex operations, preferably in aseptic or cell therapy manufacturing.
• Strong understanding of cGMPs, FDA regulatory requirements, and operational best practices.
• Demonstrated experience driving continuous improvement, operational transformation, and cross-functional collaboration.
• Proficient in Microsoft Office Suite; familiarity with manufacturing systems (e.g., MES, ERP) a plus.
• Experience with regulatory inspections and audit preparedness.
• Strong interpersonal, communication, and leadership skills with a proven ability to influence at all organizational levels.

Working Conditions and Physical Requirements:

• Some travel may be required.
• Ability to sit or stand for extended periods of time.
• Intermittent walking to gain access to work areas.
• Finger dexterity sufficient to use a computer and to complete paperwork activities
• Vision sufficient to use a computer, to read written materials and to complete paperwork activities;
• Hearing sufficient to communicate with individuals by telephone and in-person
• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs and lift up to 50 lbs.
• 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.