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Analytical Scientist
Ref No.: 17-03067
Location: Summit, New Jersey
Start Date / End Date: 10/30/2017 to 10/27/2018
Analytical Scientist, Analytical Development

Description

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.

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

The 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.

o Support drug substance process development including characterization of starting materials, intermediates and final API.
o Support drug product formulation and process development including characterization of the process and finished product.
o Develop, optimize and validate analytical methods.
o Generate, interpretate and summarize laboratory data.
o Adhere to all relevant compliance requirements.
Ensure that all facilities, equipment and personnel are and remain in compliance with cGLP / cGMP, FDA and EMA requirements, appropriate SOPs and corporate policies.

Qualifications

Prerequisites:
o Completed BS in Chemistry (or relevant discipline) and minimum of 8+ years of pharmaceutical laboratory experience required; or
o Completed MS in Chemistry (or relevant discipline) and minimum of 6+ years of pharmaceutical laboratory experience required; or
o Completed Ph.D. in Chemistry (or relevant discipline) and minimum of 4+ years of pharmaceutical laboratory experience required

Experiences Required:
o Extensive laboratory experience with such as HPLC, GC, UV, water activity, KF, IR.
o Extensive laboratory experience of dissolution method development and testing.
o Ability to work independently.
o Fluency in synthetic chemistry, drug substance processing, formulation development, pharmaceutical processing or pharmaceutical sciences is expected.
o Strong problem-solving and troubleshooting skills.
o Strong capabilities in experimental design and execution.
o Strong verbal and written communication skills.
o Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidances.
o Familiarity with the USP and other compendia.
o Academic background in Analytical Chemistry or an allied chemistry discipline (e.g. Physical, Organic) with demonstrated analytical capabilities.

Experience in one or more of the following areas are a plus:
o Parenteral drug product development.
o Late stage product development experience
o Quality by Design