Celgene Senior Technician, Drug Product Development Operations in Summit, New Jersey

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.

Senior Technician, Drug Product Development (DPD) Operations

Development Process Area

Location: Summit, New Jersey, United States

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:

Celgene Drug Product Development Operations seeks to hire a Senior Technician with oral solid dosage operations experience for (primary) Development Manufacturing responsibilities, and (secondary) GMP Manufacturing responsibilities. This position will report to the Manager of DPD Operations.

The Senior Technician position focuses on the daily operations and activities within the Drug Product Development Process Area, which include operation of small scale, bench scale and pilot scale solid dose process equipment. Responsibilities include weighing and dispensing of raw materials, executing batch processes according to batch record instructions; setting, operating and cleaning of the process equipment and operations area / isolators according to established procedures. This position will also support activities within the DPD GMP Manufacturing Area as required.

The Senior Technician will develop understanding of department and business processes in support of Development and GMP OSD Manufacturing operations objectives. The incumbent must be detail oriented, have the ability to leverage prior relevant “hands-on” process knowledge, possess strong technical and mechanical aptitude skillset to operate and troubleshoot the process equipment. The Incumbent must also demonstrate strong communication skills and possess the ability to successfully interact with different groups across multiple levels within and external to the Drug Product Development Department.

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

  • Participates in the daily operations of the Drug Product Development (DPD) Facility.

  • Prepares and operates process equipment per area schedule.

  • Follows procedure and batch record instructions, and completes subsequent equipment and area cleaning activities per established procedures.

  • Executes experiments / batch record instructions and documents results using good Documentation Practices.

  • Develops understanding and assembly of weekly process schedule assignments for DPD Facility.

  • Assists with the ordering and maintenance of chemical and consumables inventories

  • Facilitates work in a “5S” organized environment.

  • Participates in equipment and facility cleaning / sanitizations.

  • Develops and maintains effective relationships with lab support staff, maintenance and calibration personnel in support of department operations.

  • Under supervision, assists with equipment repair / preventative maintenance / calibration activities in accordance process area schedules.

  • Prepares and operates containment hoods and enclosures, monitoring performance and airflows.

  • Possesses strong technical and mechanical skillset. Capability to troubleshoot process and equipment issues, provides feedback for problem resolutions.

  • Supports departmental objectives – Compliance, Environmental Health and Safety, budget, equipment input, procedural directions.

  • Capable of sustained work with potentially hazardous material in isolator / containment and / or gowning with personal protective equipment / PPE / Respiratory protection.

  • General understanding of Root Cause Analysis and CA/PA methodologies.

  • Assists with preparation and execution of equipment installations into the facility.

  • Supports commissioning / qualification / testing activities and executions (IQ/OQ/PQ).

  • Provides input and partners on writing of Standard Operating Procedures, work practices, checklists, development reports, etc. in support of department objectives.

  • Partners effectively with internal and external resources as required in support of department objectives.

  • Handles samples and materials ensuring proper handling and chain of custody.

Experience/Knowledge/Skills Required:

  • HS Diploma or Trade Certificate with 8 years relevant experience; Associates Degree with of 6 years relevant experience; or, Bachelor of Science Degree with of 4 years relevant experience required in Pharmaceutical Science, Engineering or equivalent discipline preferred.

  • Relevant experience in Oral Solid Dosage Development, GMP Process, Facilities and Operations.

  • Ability to work in isolator / containment apparatus, or while gowned with personal protective equipment.

  • Ability to periodically lift up to 80 lbs. when required in support of equipment set-up and cleaning activities. .

  • Ability to work in isolator / containment apparatus, or while gowned with personal protective equipment.

  • Strong communication skills (oral & written).

  • Demonstrate strong equipment, process and problem solving capabilities.

  • Hands-on experience, strong technical and mechanical aptitude skills required.

  • Proficient with computer software programs / applications; and capable of preparing technical reports as required.

  • Demonstrates an initiative for advancement within department / organization.

  • Ability to work on project teams in support of Formulations and / or department related initiatives.

#LI-POST

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.