Analytical Method Development Chemist

Department: Quality



Location: 1 Opening in Newburyport, MA and 1 Opening in Devens, MA



Reports To: Director of Quality



Type of Position: Full Time



Requirements: Minimum of a Masters Degree in Chemistry, minimum of 5 years previous experience in pharmaceutical method development/validation required.



Responsibilities:

Develop and validate both compendial and noncompendial analytical methods for raw materials, in-process materials, final product and stability testing.



Conduct product degradation studies and maintain the in-house reference standard qualification system



Provide technical support for the Quality Control and R&D laboratories, including instrument troubleshooting, routine maintenance and training.



Operate, maintain and calibrate analytical instrumentation including HPLC, GC, UV, IR and TOC.



Write and follow analytical test methods, validation protocols and reports in compliance with current regulatory requirements and industry standards.



Characterize noncompendial standard materials through a variety of testing to establish assay and purity.



Maintain, follow, and update Standard Operating Procedures for the Quality Control laboratory.



Maintains accurate records.




Other duties may be assigned as required.

PCI SYNTHESIS OFFERS A COMPETATIVE WAGE AND BENEFITS PACKAGE.