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Job Details

Principal Analytical Chemist - Pharmaceutical

Company name
Job Juncture, Inc

Warren, NJ

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Our client is a global bio-pharmaceutical company leading the way in medical innovation! They are discovering and developing therapies that will change the course of human health.


* build in-depth and comprehensive knowledge of our clients products and processes through well-designed analytical studies

* be responsible for the scientific leadership for multiple projects directly and will impact many projects within Analytical Development.

* work independently

to support laboratory based de novo

analytical methods development, chemical characterization studies and chemical

stability characterization evaluations

* provide leadership oversight for activities that will

be performed in accordance with cGLP/cGMP regulations

* 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.

* support drug

substance and drug product impurity characterization and identification.

* do more fun and impactful things!


* Degree in

Chemistry (or relevant discipline)

* Years of experience in industry

* Fluency in

synthetic chemistry, drug substance processing, formulation development,

pharmaceutical processing with a deep understanding of pharmaceutical

sciences related to drug product development.

* Mastery of

chemistry with extensive expertise in measurement science.

* Experience in

the development and performance of analytical tests for a variety of drug

substances and products (including solid oral dosage forms and


* Knowledge of

dissolution method development and testing, biopharmaceutical

classification system, and IVIVC / IVIVR.

* Strong

statistical knowledge and capabilities.

* Understands

drug development and works to build CMC dossier for regulatory submissions

as an author/reviewer.

* Sound Judgement

and ability to negotiate and resolve issues related to complex scientific,

regulatory, and compliance challenges.

* Strong

business acumen.

* An expert

related to cGLP/cGMP and applicable FDA, EMA and ICH guidance.

* Mastery of

USP and other compendia and how they guide drug development decisions.


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Company info

Job Juncture, Inc
Website :

Company Profile
With almost 1000 recruiters in over 350 locations, and thousands real, current and unique jobs, Job Juncture is your portal to one of the largest groups of recruiters in the world. Our mission is to make your job search as easy and painless as possible. Every job that is at Job Juncture is real and verified current within the most recent 30 days. Every application is read by the real human being who is working on the job applied for. We have recruiters who specialize in virtually everything, including engineering, finance, software, nursing, retail, manufacturing, legal, tax, pharmaceutical, chemical, aerospace, defense, and human resources, at all salary ranges from entry level to over $600K.

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