Principal Scientist - Method Development
* Greater Boston Area
* Salary Based on Candidates Experience/Market Value
This Position will have the following Responsibilities:
* Develop Analytical Methods for all products in process control, final product release or in stability testing, all while in compliance with cGMP
* Write and execute validation protocols and reports for clinical phase of API.
* Write and revise SOPs to improve laboratory functions and practices in alliance with company and federal regulation standards
* Act as SME (Subject Matter Expert) to aid in delivery of analytical results related to manufacturing and development variations, LIR//OOS, and QI
* Able to handle multiple tasks while meeting timelines and adapting to changing priorities
* Leading a team of more junior method development scientist
The Ideal Candidate will have the following skill set:
* A PhD in Organic Chemistry or Analytical Chemistry with primary experience in field of chromatography and spectroscopy
* Minimum 10-year experience in Method Development, API manufacturing.
* Prior work experience in a CDMO
* Very hands on individual with extensive experience on the bench
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