Celgene Scientist, QC Systems in Phoenix, Arizona

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.

Purpose and Scope of Position

The QC Systems Scientist is responsible for maintaining the analytical testing equipment in a state

of regulatory compliance; installing and calibrating new equipment in the Quality Control

laboratory.

Required Competencies: Knowledge, Skills, and Abilities

 Intermediate knowledge, operational skill, and troubleshooting of pharmaceutical laboratory

equipment (e.g., HPLC, GC, PSA, FTIR, TOC, ICP).

 Intermediate understanding of an instrument calibration program in a regulated environment.

 Ability to write and execute instrument qualifications/validations and maintain appropriate

documentation.

 Intermediate strategic thinking and the ability to work independently.

 Ability to interact with internal resources, contractors and vendors to justify new laboratory

equipment.

 Ability to interact with regulatory auditors as Subject Matter Expert (SME) for laboratory

equipment.

 Intermediate ability to train and coach others.

 Ability to communicate effectively with peers, department management and cross-functional

peers.

 Basic knowledge of budgeting, sourcing, and acquiring new capital equipment.

 Advanced knowledge of cGMP, JP, USP and EP.

Duties and Responsibilities

Maintain laboratory equipment in a cGMP compliant environment.

 Troubleshoot and perform repairs on laboratory equipment.

 Schedule and monitor activities that are performed by outside vendors on laboratory

equipment.

 Maintain instrument records and enter events in to the asset management program.

 Perform monthly requalification of laboratory instruments per work schedule.

 Create Change Controls for changes made to qualified laboratory equipment.

 Perform peer reviews ensuring all qualification/calibration testing has been performed in

compliance with all regulatory requirements.

Write and assist with technical documents

 Write and execute IQ, OQ, PQ and validation protocols including summary reports for

new and existing laboratory equipment.

 Write, modify and review SOPs for new and existing laboratory instrumentation.

 Write user requirements specifications and assist with configuration specifications.

 Perform technical review of documents and evaluate compendia updates to ensure

compliance with applicable regulations.

Purchase and Install new equipment

 Research, source and price new equipment. Keep current on new instrument technology

for laboratory.

 Communicate with QC Management on current and future equipment needs.

 Write and defend Capital Acquisition Requests (CAR) to upper management.

 Keep current on Industry validation/qualification requirements by attending seminars and

webinars throughout the year.

Provide guidance

 Assist laboratory personnel with instrument performance and software issues.

 Assist in the training new laboratory employees.

Perform other duties as assigned.

Education and Experience

 High school diploma or equivalent required.

 Bachelor Degree preferred, preferable in Science.

 4 years relevant work experience required, preferable in a regulated environment.

 An equivalent combination of education and experience may substitute.

Working Conditions

 The incumbent will be required to push, pull, reach, balance, and/or lift greater than 20 lbs.

for 2 hours, approximately 5 times per week.

 The incumbent will be required to stand for extended periods of time, up to 6 hours per day.

 This position requires regular medical surveillance and may require incumbent to wear a

respirator or gown.

 The incumbent must be able to distinguish colors and possess correctable vision to 20/20,

annual eye exam is required.

 The incumbent must analyze numerical values on a daily basis.

 The incumbent will be working a laboratory setting up to 6 hours per day.

 The incumbent will occasionally be working around hazardous materials to include chemical

agents up to 6 hours per day.

 The incumbent often works for extended periods alone, up to 8 hours per shift.

This job description is intended to describe the general nature and level of work being performed by the

person assigned to this position. The primary duties and responsibilities are intended to describe those

functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned

to this position. There are other duties and responsibilities that are considered incidental or secondary to

the overall purpose of this job. Employees holding this position will be required to perform any other

job-related duties as requested by management.

#LIPOST

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

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.