Celgene Supervisor, QC Chemistry (3rd Shift) in Phoenix, Arizona
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.
SUPERVISOR, QC CHEMISTRY (3rd Shift)
Purpose and Scope of Position:
The Supervisor, QC Chemistry, is responsible for oversight of daily activities pertaining to the testing and timely disposition of in-process, finished product, stability and raw material samples to ensure that all required activities are completed and documented in an accurate and compliant manner.
Required Competencies: Knowledge, Skills, and Abilities:
· Intermediate understanding of regulatory filings and their impact to daily operations.
· Intermediate proficiency in Microsoft Word, Outlook, and Excel.
· Advanced ability to use and troubleshoot instrumentation.
· Advanced knowledge of how to conduct effective training of analysts.
· Advanced knowledge of the analytical techniques, software and equipment used in a laboratory.
· Intermediate ability to make formal presentations to internal and external audiences.
· Basic management and organizational skills.
· Basic team and individual leadership skills.
· Advanced understanding of relevant scientific and technical principles.
· Ability to use PPE effectively.
· Basic project management skills.
· Advanced knowledge of cGMP, JP, USP, and EP.
· Intermediate written and verbal communication skills.
· Ability to work independently for extended periods of time.
· Ability to pass an initial full physical including a respiratory certification with annual monitoring.
Duties and Responsibilities
- Oversee and schedule testing activities to ensure timely completion.
· Coordinate between management and leads to assign duties each week.
· Communicate with PPIC on what lots must be released.
· Communicate with Incoming and PPIC on what raw materials require testing and release.
· Communicate with QA to ensure release is performed in a timely manner.
· Determine and communicate priorities to the team.
· Effectively delegate tasks. Perform review and approval of documents to ensure appropriate documentation of data and changes.
· Review and approve testing data.
· Perform evaluations and action item assignments related to change control.
· Review and approve document changes for SOPs, specifications, and other technical documents.
· Mentor analysts regarding the impact and importance of change control; for example, evaluating the impact of changing specific directions in one SOP that is referenced in another.
· Mentor analysts on appropriate documentation; for example, making appropriate corrections.
- Coach and develop employees to ensure they have the skills and abilities to perform the duties assigned to them.
· Participate in hiring processes.
· Determine training schedule and develop training content.
· Provide feedback to direct reports through regular coaching sessions.
· Utilize company-guided performance management tools and processes.
· Ensure analysts are focused on safety and proper use of PPE.
- Coordinate with other departments (maintenance, metrology, etc.) regarding work they need to perform for the laboratory.
· Respond to requests from other departments in a timely manner.
· Provide appropriate and effective level of understanding of activities occurring in the laboratory so that other groups can evaluate impact to the work they need to perform.
· Request information from other groups as needed to determine priorities of required work.
- Perform analyses and determine appropriate actions with regards to investigations, deviations, CAPAs, and continuous improvement to ensure continued compliance with all cGMP requirements.
· Anticipate and troubleshoot issues with regards to processes, procedures, documentation, instrumentation and electronic systems.
· Use a scientifically sound, risk-based approach to determine impact and root cause of issues identified.
· Develop and implement corrective actions.
· Lead and develop best practices.
- Performs other tasks as assigned
Education and Experience:
· Bachelor’s degree preferred, preferably in Chemistry or related science;
· 4 years relevant work experience required, preferably in a regulated industry.
· An equivalent combination of education and experience may substitute.
· The incumbent will be required to type for up to 4 hours per day.
· 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.
· 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 occasionally be working in a laboratory setting up to 2 hours per day.
· The incumbent will occasionally be working around hazardous materials to include chemical agents up to 4 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.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.