Supervisor, Bioassay at Dendreon Pharmaceuticals, LLC in Union City, Georgia

Job Description:

Dendreon Pharmaceuticals, LLC


Supervisor, Bioassay

US-GA-Union City

Job ID: 2024-2995
Type: Regular Full-Time
# of Openings: 1
Category: Quality Control Mfg
Union City

Overview

Who we are.

Dendreon is making the battle against cancer personal. Our flagship product PROVENGE® (sipuleucel-T), was the first FDA approved immunotherapy for the treatment of metastatic castrate resistant prostate cancer and is made from the patient's own immune cells.

If you are looking to positively impact the lives of patients, we want you to join our team. We have Immunotherapy Manufacturing Facilities located in Seal Beach, CA and Union City, GA. A sizeable Research & Development group based out of Seattle, WA, and a highly skilled Commercial team countrywide.

Core Values:

• Put Patients First. Every day is a new opportunity to improve the lives of patients living with cancer
• Act with Integrity. Be honest, transparent, and committed to doing what’s right in every situation.
• Build Trust. Building trust takes time. Engage teammates, be candid and transparent. Over communicate and seek feedback.
• Raise the Bar. Harness continuous improvement, foster innovation and elevate our people.
• Drive Results. Be accountable and execute – we win together when everyone performs.

Your Role:

Responsible for the direct testing of in-process and final product samples in compliance with the established procedures and quality systems, in addition to providing daily supervision of lab operations (people, process, product) for one or more functional areas within Quality Control. Ensures the site, process, product, and personnel are compliant with regulatory requirements.

Responsibilities

Your Work:

• Provides immediate supervision and assigns tasks to reporting staff. Provides general and direct supervision to exempt employees and/or skilled nonexempt employees. A portion of time may be spent performing individual tasks.
• Performs assays for release, clinical or stability testing on in-process and finished products. These test methods may include Flow cytometry, ELISA (Bead Identity), Endotoxin, Total Nucleated Cell count, Viability and Gram Stain.
• Acts as a technical expert within a specific functional area.
• Performs assays for qualifying raw materials.
• Supervises maintenance and operational use of laboratory equipment.
• May participate in the development of standards, methods and procedures for inspecting, testing and evaluating the quality of products.
• Conducts and manages laboratory investigations and relevant exception reports. Makes recommendations for corrective action, and implements as needed, to ensure conformity with quality specifications.
• Ensures in-process and finished products conform to company standards and satisfy GMP
• Represents QC Bioassay in cross-functional teams, projects, and GXP-related problem resolution.
• Evaluates and develops personnel to ensure functional objectives are met. Performs ongoing assessment of development and training needs of reporting staff to ensure continue development of personnel.
• Receives assignments in the form of objectives with goals/measures predefined. Provides guidance to employees according to established policies and management directives. Work is reviewed by management to measure meeting of objectives. Administers company policies that directly affect staff members. Recommends changes to area policies.
• Works on problems of moderate scope in which analysis of situations or data requires review of identifiable factors. Exercises independent and technically sound judgment within defined procedures and policies to determine appropriate action. Acts as advisor to area staff and becomes actively involved as required to meet schedules or resolve problems. Frequently interacts with direct reports, outside customers and functional peer groups at various management levels. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects/schedules, etc.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent

Job Requirements:

• Minimally 6+ years of experience years related experience in cGMP/FDA regulated industry.
• Typically, 3+ years in a leadership role.
• Thorough knowledge of cGMP/QSR/ICH/FDA regulations.
• Experience with inspections/audits by the FDA and other regulatory agencies.
• Ability to independently prioritize and successfully manage complex and competing projects.
• Proficient in MS Office applications and MS Project.
• Strong troubleshooting and problem-solving skills.
• Strong team leadership and staff development skills.
• Excellent oral and written communication skills.

Working Conditions and Physical Requirements:

• 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 lift up to 25 pounds. Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas.
• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs and lift up to 50 lbs.
• May be required to work alternate shifts.
• Ability to gown aseptically for work in Clean Room environments.
• 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.

PI249292951

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