Celgene Engineer II, Commercial Product Development 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.

ENGINEER II, COMMERCIAL PRODUCT DEVELOPMENT

Location: 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.This position is responsible for supporting commercial product definition, leading process development, scale-up, registration stability batch mfg., technology transfer, supporting validation, and providing in-line technical support.

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

  • Member of a dynamic scientifically driven team, dedicated to the development and optimization of robust manufacturing processes for drug products.

  • Leverage basic understanding of formulation design and development to support the commercial product definition

  • With minimal supervision, execute process development strategies to define manufacturing processes for commercialization.

  • With minimal supervision, design and execute complex experiments to characterize drug product manufacturing processes utilizing various technologies.

  • Apply fundamental engineering principles to characterize and solve process challenges across multiple unit operations, utilizing both experimental and process simulation/modeling approaches.

  • Utilize appropriate research tools, instrumentation, technologies, and methodologies to support efficient and effective drug product process development.

  • Support drug product process development/technology transfer to Contract Research/ Manufacturing Organizations.

  • Provide technical support to the clinical manufacturing activities

  • Prepare technical reports, publications, oral presentations and contribute to the preparation of CMC regulatory documents.

  • Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.

Qualifications

Prerequisite:

Ph.D. with 2 -4 years experience in engineering or related field; or

M.S. with minimum of 6 years experience in engineering or related field; or.

B.S. with minimum of 8 years in engineering or related field.

Skills/Knowledge Required:

  • Background in pharmaceutical development as it relates to formulation development and process development/optimization.

  • Experience in scale-up and technology transfer, moving from laboratory to pilot plant and production scale.

  • Experience across various solid oral dosage conventional and enabling manufacturing technologies is desired.

  • With minimal supervision, demonstrated capability in execution of an experimental program to address issues of process robustness, productivity, and cost, integrating efforts with specialists in other technical disciplines.

  • Knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design, and statistical process control fundamentals.

  • Knowledge of cGMPs during pharmaceutical development and clinical/commercial manufacturing.

  • Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment. Ability to work with minimal supervision and be a contributing member on cross functional assignments. Strong verbal and written communication skills are essential.

  • Knowledge of applicable regulations and regulatory filing (INDs/NDAs) expectations.

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.

#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.