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Scientist I, Analytical Development

Company: Celgene
Location: Summit
Posted on: June 15, 2019

Job Description:

Req #:
Location: Summit, New Jersey, United States
Job Category: Technical Development
Work Location: 556 Morris Avenue 07901
Organization: Pharmaceutical Development
Employee Status: Full-time
Job Type: Regular
Analytical Development Analytical Development is a science-driven organization dedicated to building in-depth and comprehensive knowledge of our products and their processes through well-designed analytical studies. We work in all phases of pharmaceutical development to oversee the analytical processes for drug substance and drug product development both internally and with external contract service providers. Our goal is to enable the establishment of specifications and robust analytical procedures that allow control of our drug substance and drug product processes to provide safe, efficacious and high quality products to the patients we serve.

Responsibilities for Scientist I will include, but are not limited to, the following:
The Scientist I position will be responsible for the development and validation of analytical methodology for the characterization of our products and processes, the creation of fundamental product and process understanding, and the advancement of innovative approaches to drug development. Support for drug candidates across all stages of development and, as needed, within our commercial product portfolio will be required.

The Scientist I should work with minimal supervision to carry out laboratory based de novo analytical methods development, chemical characterization studies and chemical stability characterization evaluations. Where required, activities will be performed in accordance with cGLP/cGMP regulations, established business processes and protocols, and applicable standard operating procedures.

  • Support drug substance process development including characterization of starting materials, intermediates and final API.
  • Support drug product formulation and process development including characterization of the process and finished product.
  • Develop, optimize and validate analytical methods.
  • Support drug substance and drug product impurity characterization and identification.
  • Generate/review laboratory clinical release and stability data.
  • Qualify/transfer analytical methodology to quality control and contract laboratories.
  • Serve on departmental, interdepartmental and project teams.
  • 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.
  • Complies with Environmental Health and Safety Requirements.
  • Contributes to ownership and advancement of lab instrumentation, work processes, and procedures. Skills/Knowledge in the following areas are required :
    • BS/MS/PhD in Chemistry (or relevant discipline) with required years of experience. Completed BS and minimum of 8 years; MS minimum of 5 years; or Ph.D. and 0-3 years in Chemistry (or relevant discipline) with pharmaceutical experience.
    • Strong statistical knowledge and capabilities.
    • Strong Scientific problem-solving skillsThese Skills are not required but advantageous at this level.
      • Familiarity with synthetic chemistry, drug substance processing, formulation development, pharmaceutical processing and/or pharmaceutical sciences.
      • Experience in the development and performance of analytical tests for a variety of drug substances and products (including solid oral dosage forms and injectables).
      • Knowledge of dissolution method development and testing, biopharmaceutical classification system, and IVIVC / IVIVR.
      • Skills in DOE, Lean and/or Six Sigma. Expectations of the Scientist I include:
        • Strong verbal and written communication skills and interpersonal skills as a team member/leader in an environment where individual initiative, collaboration and accountability are valued.
        • A demonstrated record of scientific accomplishment, laboratory experimentation, publication and presentation.
        • Direct impact on departmental performance.
        • In-depth knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance.
        • Familiarity with the USP and other compendia and how they impact drug development
        • Strong problem-solving and troubleshooting skills.
        • Strong capabilities in experimental design and execution.
        • Ability to work independently.#LI-POST

          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. Associated topics: bacteria, biomedical, biopharmaceutical, diet, dietician, histology, immunoassay, industrial hygienist, nephrology, patient

Keywords: Celgene, New York , Scientist I, Analytical Development, Other , Summit, New York

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