Scientist I, Analytical Development
Posted on: June 15, 2019
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
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
- Support drug substance process development including
characterization of starting materials, intermediates and final
- Support drug product formulation and process development
including characterization of the process and finished
- Develop, optimize and validate analytical methods.
- Support drug substance and drug product impurity
characterization and identification.
- Generate/review laboratory clinical release and stability
- Qualify/transfer analytical methodology to quality control and
- Serve on departmental, interdepartmental and project
- 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
- Review analytical data for completeness and correctness.
- Complies with Environmental Health and Safety
- 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
- 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
- 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
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
\"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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