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Position:
The Principal Scientist will report to the Head of Analytical Sciences and will serve as the analytical lead in cross-functional product development tea

Employer:
Arena Pharmaceuticals

Description:

Write relevant CMC sections of regulatory dossiers and review responses with a high degree of independence by building complex regulatory rationales to justify specifications, and establish product shelf-lives.

Manage a CMO Network to develop analytical methods, support process chemistry, support formulation development, and provide CTM release and stability testing. Oversee laboratory activities, data reviews, and reporting practices.

Collaborate closely with key partners such as Non-Clinical/Safety Assessment, internal and external Quality Assurance, Business Development and others as needed.



Qualifications/Experience:

PhD in a relevant scientific discipline with 5 years of Analytical Project Lead/CMC experience, MS with 8 years of Analytical Project Lead/CMC experience, or BS with 12 years of Analytical Project Lead/CMC experience

Advanced Skills in analytical method development (e.g. HPLC (chiral and achiral), ultra-high-pressure LC, HSGC, MS, particle size testing, dissolution)

Strong Knowledge of cGMP, ICH Quality and Safety Guidelines, QC Systems, and CTD writing/ reviewing.



Location: San Diego

Contact: https://www.arenapharm.com/careers/?gh_jid=4424678002

Post Date: 9/9/2019 2:23:59 PM
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