Search Jobs

Scientist - Analytical Chemistry

Edison-New Brunswick Metro Area, NJ

Posted: 10/31/2018 Job Type: Scientific Job Number: JN -102018-22947
  • BS. MS or PhD with a Minimum of 3+ years of relevant experience in the pharmaceutical industry - small molecules, analytical testing is required.

    Extensive experience with HPLC and Dissolution testing is an absolute must
    Knowledge of Dissolution methods development, GC, FT-IR, KF, etc. required.
    In-depth knowledge of cGLP/GMP; applicable FDA and ICH guidances a MUST.
    Familiar with USP and other compendia.
    Working knowledge of Empower
    Must have working familiarity with cGMP practice.
    Responsible for assisting in method development, conducting method validation, performing laboratory research and/or routine sample analysis under minimal guidance of a supervisor.
  • Responsibilities will include, but are not limited to, the following:
    Assist senior scientist to carry out methods development, optimization and validation for the analysis of drug substances, and finished products in accordance with cGMP regulations, established protocols, and applicable SOPs.
    Adhere to all pertaining compliance requirements.
    Contribute data for preparation of development, validation and technology transfer reports.
    Communicates results according to project timelines and works with colleagues and collaborators to
    understand project needs.
    Performs troubleshooting within method guidance.
    Performs reference standard qualification/requalification tests.
    Performs release and stability testing in accordance with established methods, specifications and
    protocols with limited supervision.
    Documents laboratory work that is detailed, timely and in compliance with GLP/GMP requirements.
Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.