Scientist, QC Tech Services
Req #: 1801871
Location: Phoenix, AZUS
Job Category: Quality
Work Location: 620 N. 51st Avenue PHOENIX 85043
Organization: Abraxis Bioscience
Employee Status: Full time
Job Type: Regular
Other Locations:US- AZ- Phoenix
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 Scientist is responsible for supporting Quality Control analytical testing for release of products.
The Scientist is responsible for validating and transferring methods into the QC laboratory,
optimizing and troubleshooting methods; assisting in teaching and training junior analysts.
Required Competencies: Knowledge, Skills, and Abilities
Hands on experience with various analytical techniques and scientific knowledge in the
characterization of pharmaceutical drug products.
Intermediate ability to accurately and completely understand, follow, interpret and apply
Global Regulatory and cGMP requirements.
Ability to interact with regulatory auditors as Subject Matter Expert (SME).
Intermediate technical writing skills.
Strong problem solving ability/mentality, technically adept and logical.
Intermediate organizational and time management skills.
Intermediate knowledge of laboratory instrumentation.
Demonstrated ability to communicate effectively with peers, department management and
Duties and Responsibilities
Independently manages projects
With assistance, designs and executes experiments, analyzes results, and writes technical
Capable of handling moderate issues and solving problems.
Prepare and present continuous improvement projects to management.
Utilize scientific principles to assist in analytical testing methods and the proper use of
Broad understanding of ICH Guidelines and can independently develop, write and execute
method Verification/transfer /validation protocols/Reports and related activities.
Assist management with investigations and deviations.
Integrate enterprise systems into the Laboratory
Assist in implementing electronic data capture software into the QC laboratory
Assist in writing appropriate interface templates to capture data results with only general
Assist with writing custom calculations to produce data results
Assist with peer review and verification of data
Serve as technical reviewer of appropriate departmental procedures
Review documentation as required by laboratory procedures
Perform verification of software templates and custom fields
Perform peer review as needed for QC Technical Services Projects
Performs other tasks 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.
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.
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.
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.