Leader, Chemical Development

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Job description

_We are looking for someone to lead the _Chemical Development for our Philadelphia area client. This role will lead a team and drive the chemical synthesis and process development of Active Pharmaceutical Ingredients (APIs) both internally and with external partners. The position is responsible to setting target synthetic strategy to be aligned with generic commercial targets.

KEY RESPONSIBILITIES

* Designs & implements synthetic strategies for the synthesis of molecules in the generic API portfolio
* Develops processes that will commercialize in the timeframe of generic project launch
* Integrates state-of-art process development techniques into synthetic development plans
* Accountable for defining internal process development deliverables and external process development activities

REQUIREMENTS

* PhD in Organic Chemistry with >10 years of chemical process development experience in the pharmaceutical industry.
* Expertise in developing and optimizing synthetic routes to enable safe, robust, cost-effective API commercialization.
* Expertise in the use of statistical methods such as design of experiments (DoE)
* Knowledge and experience in implementing technologies such as PAT, continuous processing, QbD Expert knowledge and implementation of regulatory guidelines
* Expert knowledge of appropriate analytical techniques for chemical process development
* Experience authoring CMC sections for INDs, NDAs, DMFs or other regulatory filings

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