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Scientist, Chemistry (Pipeline)
Ref No.: 18-01043
Location: Summit, New Jersey
Position Type:Contract
Start Date / End Date: 04/16/2018 to 04/30/2019
Job Description :
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.
• Other duties as assigned by his/her supervisor.

Skills/Knowledge Required:

*Master preferred but PhD and BS will also be considered.

§ Experience with HPLC, GC, FT-IR, KF etc. required.
§ Knowledge of Dissolution methods developing and testing
§ In-depth knowledge of cGLP/GMP; applicable FDA and ICH guidances a must
§ Familiar with USP and other compendia
§ Working knowledge of Empower required.
§ Must have working familiarity with cGMP practice and safety awareness for analytical laboratories.