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Job Details

Principal Scientist Analytical Development

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.

The Principal


* be responsible for the development and validation of analytical


* create fundamental product and process understanding

* advance innovative approaches to drug development

* provide support for drug candidates across all stages of development

* carry out laboratory based de

novo analytical methods development, chemical characterization studies and

chemical stability characterization evaluations

* have

organizational and interdepartmental responsibilities with regards to leading

workgroups, cross-functional teams, strategy

development/implementation/execution, and cultural initiatives.


* 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

* 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.

* Understands

drug development and works to build CMC dossier for regulatory submissions

as an author/reviewer.

* Advanced

skills in DOE, Lean and/or Six Sigma.

* Familiar

with modern laboratory equipment and automation.

* Understands

and applies Quality by Design principles when required

* Advanced

skills in PAT and chemometrics.

* Exceptional

verbal and written communication skills and interpersonal skills as a team

member/leader in an environment where individual initiative, collaboration

and accountability are valued.

* A

demonstrated record of scientific accomplishment, laboratory

experimentation, publication and presentation.

* 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.

* An

absolute commitment to and demonstrated proficiency in employee



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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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