Description

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.

Job Summary:

The Sr. Quality Specialist I, Manufacturing Quality, will perform a wide variety of QA activities to ensure compliance with applicable regulatory requirements.

NOTE: This is a TEMPORARY role from May to December 2026 and will be on-site at our Seal Beach, CA location.

• Perform activities related to batch record process flow (i.e. Issuance, Review, Closure).
• Perform incoming receipt of patient material and packing of Final Product.
• Perform Final Product disposition and release.
• Perform Raw Material review and approval.
• Review and approve GMP facility work orders
• Review and approve system, equipment or method validation protocols, reports, and related validation documents (ie. Requalification, URS, FRS, RBRAs etc)
• Conduct product complaint investigations
• Processes deviations and non-conformances.
• Track/trend metrics and reports data to Senior Management for escalation as necessary.
• Processes change controls (authors/review change impact and risk assessments).
• Provide support for any other duties assigned.
• Represents department in cross-functional teams, projects and GXP-related problem resolution.
• Uses professional concepts and company policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
• Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Normally receives no instructions on routine work, and general instructions on new assignments.

Required Experience & Education:

• Bachelor's degree in a scientific discipline or equivalent.
• 7+ years in a cGMP regulated environment with related experience within the biopharmaceutical or biotechnology industry preferred. 10+ years of relevant work experience can be substituted for a 4-year course of study leading to a Bachelor's degree.
• Knowledge of current regulatory requirements in support of cGMP manufacturing operations (i.e., FDA and ICH guidelines).
• Experience in knowledge of sterile products aseptic manufacturing processes and testing preferred.
• Understanding of facility/building related knowledge (ISO classifications, air handling units, differential pressures.
• Proficient in MS Office applications.
• Ability to gown aseptically for work in Clean Room environments.

Working Conditions and Physical Requirements:

• Limited use of laboratory equipment, chemicals and biological materials.
• 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
• Ability to life up to 25 pounds. Limited exposure to (2C 8C); (-20C).
• 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
•  

PI284508971