Celgene Associate Specialist, Biospecimen Operations in Cambridge, Massachusetts

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.

Summary/Scope

This is an entry level position in the Biospecimen Operations (BSO) department at Celgene. Under direct

supervision in a fast-moving team-based environment, the Associate Specialist will gain exposure to and

develop competency to provide routine biospecimen management and clinical trial support for oncology and

inflammation/immunology programs. The ideal candidate is a demonstrated quick learner and team-player

who is detail-oriented; able to multi-task, supporting several projects simultaneously; has basic understanding

of the broader context and impact of the support that he/she provides; and actively seeks guidance from peers

and managers to learn how to identify and resolve problems.

Responsibilities will include, but are not limited to, the following:

The Associate Specialist will participate in activities that support TD and clinical teams in the implementation

and maintenance of a biospecimen management system for clinical studies in some of the following areas under

direct supervision:

  1. Biospecimen operations: Develop ability to support assigned clinical protocols and follow good

clinical practices (GCP), standard operating procedures (SOPs) and working procedures (WPs).

Perform assigned tasks that pertain to clinical trial and biomarker operations support.

  1. Biospecimen management: Learn how to utilize software tools to track biospecimens, identify

discrepancies, verify and document consent and ensure compliant utilization of biospecimens by

following written procedures. Assist with following up and resolving discrepancies.

  1. Clinical study teams: Using basic skills learned in TDOps, execute on assigned tasks on the planning

and designing of clinical biospecimen logistics. Create and update biospecimen laboratory manuals in

collaboration with peers. Will attend study team meetings.

  1. CROs and Vendors: Perform assigned tasks as directed by his/her manager on the planning and

designing of clinical biospecimen logistics with preferred vendors and in the manufacture of sample

collection kits.

Skills/Knowledge Required:

Familiarity with each of the following areas:

 Clinical Trials: Familiar with FDA regulatory requirements and GCP and clinical trials.

 Scientific/Laboratory Skills: Familiar with laboratory techniques used in the life sciences, principles in

clinical research and clinical procedures involving blood/biopsy collection, handling and processing.

 Drug Development: Familiar with the basic drug development process.

 Basic computer skills in Microsoft Office.

 Experience with databases and intermediate-level Excel a plus.

Bachelors Degree in a life sciences or healthcare related field with 2+ years related

professional experience in an academic clinical research setting,

clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

OR

Masters Degree in a life sciences or healthcare related field and 1+ years related

professional experience in an academic clinical research setting,

clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

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.