Scientist II, Biologics Analytical Development

Employer
Celgene
Location
Summit, New Jersey, United States
Posted
Jun 17, 2019
Ref
1901528
Required Education
Doctorate/PHD/MD
Position Type
Full time
Req #: 1901528
Location: Summit, New Jersey, United States
Job Category: Technical Development
Work Location: 556 Morris Avenue 07901
Organization: Chemistry
Employee Status: Full-time
Job Type: Regular

The successful candidate will be highly motivated to work within a science focused, collaborative, multidisciplinary drug substance and drug product development environment to achieve the company's aggressive drug development targets. As part of Celgene's Biologics team, this Scientist II will play an important role throughout the development of new drug candidates from discovery to commercialization, contributing to the advancement of new therapeutics in the areas of hematology, oncology, inflammation & immunology.

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

The Scientist II position will be responsible for the development of analytical methodology using liquid chromatography (LC) for release and characterization of our products, the creation of fundamental product and process understanding, and the advancement of innovative approaches to drug development.

The Scientist II should work with minimal supervision to carry out laboratory based de novo analytical methods development, product characterization studies and stability characterization evaluations.
  • This Scientist II is responsible for the development, optimization, qualification, and implementation of the comprehensive analytical methods to advance protein development
  • Act as analytical lead to represent analytical function in CMC team and manage internal/external analytical activities.
  • Manage method transfer to quality control and contract laboratories.
  • Guide method development, validation, and troubleshooting at CROs.
  • Lead high throughput method development and implementation.
  • Support drug substance process development, impurity characterization and identification as needed
  • Report and discuss analytical results and conclusions both orally and in writing.
  • Write formal reports for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.
  • Review analytical data for completeness and correctness.
  • Ensure that all facilities, equipment, and personnel are and remain in compliance with applicable regulatory requirements, appropriate SOPs and corporate policies.

Skills/Knowledge required:
  • Background in Analytical Chemistry or a Scientific Discipline with demonstrated analytical capabilities. Ph.D. with relevant 3+ or BS/MS with 14+ industrial experience.
  • Demonstrated track record in methods development and validation of HPLC based methods for therapeutic proteins is a must.
  • Knowledge and experience with product characterization using MS is expected.
  • Good understanding of ICH validation guideline and GMP experience are required.
  • Ability to work independently with strong problem-solving and troubleshooting skills.
  • Strong verbal and written communication skills

Skills/Knowledge in the following areas are a plus:
  • Solid understanding of how Biopharmaceutical Development integrates with key business partners
  • The ideal candidate will also have experience in interacting with CROs
  • Demonstrated ability for critical thinking, problem solving and innovation


About Us

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.