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Celgene Manufacturing Associate II - Bothell, WA in Denver, Colorado

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Juno Therapeutics, a Celgene company, is a clinical-stage company developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer.Juno Therapeutics is a clinical-stage company developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer.

Learn more about Celgene's CAR T team and hear what they have to say about the amazing work they’re doing in the world of medicine here: https://www.youtube.com/watch?v=QGp_lyopogY&feature=youtu.be

Job Summary:

This position is based at our Juno Manufacturing Plant (JuMP) in Bothell, Washington - relocation assistance may be available for qualified candidates.

The primary focus of the Manufacturing Associate role will be cellular therapeutic manufacturing at JuMP during process transfers, routine production, and technology improvements. The key deliverables for this role are (1) helping to establish the JuMP manufacturing operations and (2) completing production assignments with a high quality and timely output.

Primary Responsibilities:

  • Performing patient process unit operations and support operations described in standard operating procedures and batch records.

  • Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.

  • Performing tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.

  • Completing training assignments to ensure the necessary technical skills and knowledge.

  • Assisting in setting up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities.

  • Writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements

  • Working with production planning, Sr. Manufacturing Manager, and lead associates to establish daily unit operations schedule that includes people, product, and material flow across multiple shifts.

Required Qualifications:

  • Bachelors in relevant science or engineering discipline, or equivalent in work experience.

  • A minimum of two years of experience in cGMP biologics cell culture manufacturing.

  • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.

  • Must have the ability to work assigned shift (Day, Night, Weekends and/or Holidays).

  • Must be able to perform aseptic processing; maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.

  • Must be able to work in a clean room environment, which is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.

  • Must have the ability to work around laboratories and controlled, enclosed, restricted areas.

  • Must be comfortable being exposed to human blood components.

  • Must be able to be in close proximity to strong magnets.

  • Must be willing to work 5:00 am - 5:30 pm or 5:00 pm - 5:30 am three to four times a week.

Preferred Qualifications:

  • Experience in cell therapy manufacturing.

  • Aseptic processing in ISO 5 biosafety cabinets.

  • Universal precautions for handling human derived materials in BSL-2 containment areas.

  • Cell expansion using incubators and single use bioreactors.

  • Cell washing processes and automated equipment.

  • Cell separation techniques and automated equipment.

  • Cryopreservation processes and equipment.

Physical Demands:

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. During higher times of processing these activities may increase.

  • Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time, throughout the day.

  • Carrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day while handling production equipment and/or materials.

  • Climb - Required to climb (use of stepladders in production areas, or stairwells) several times a day.

  • Bend and Kneel - Required to bend or kneel several times a day.

  • Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies up to 25 pounds several times a day, throughout the day.

  • Moving Head and Neck – Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day, throughout the day.

  • Twisting - Required movement of twisting waist while setting up equipment several times a day, throughout the day.

  • Repetitive Use - Required repetitive use of arms/wrists/hands while setting up equipment and processing several times a day, throughout the day.

  • Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.

COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

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