GMP Quality Manager New Jersey
4/9/2015 9:25 AM

SUMMARY OF POSITION Amicus Therapeutics is seeking a GMP Quality Assurance (QA) Manager with in depth experience of biologics manufacturing. Reporting to the GMP Director of Quality Assurance, the QA Manager will provide Quality oversight and support to the Technical Operations group for the production of non-clinical, clinical and commercial products. The QA Manager will be accountable for drivi  ...View Job
Associate Director / Director, CMC Regulatory Affairs New Jersey
4/6/2015 11:01 AM

SUMMARY OF POSITION The Director, CMC Regulatory Affairs will provide regulatory leadership and oversight to the Amicus Therapeutics cross-functional teams in both pre- and post-approval roles. Emphasis will be primarily on the biologics product candidates. The ideal candidate will provide regulatory support for writing and maintaining CMC sections of INDs and equivalent IMPD documents, and provi  ...View Job
Associate Director, Drug Product Development New Jersey
4/6/2015 10:51 AM

SUMMARY OF POSITION The successful candidate will be responsible for overseeing drug development and manufacturing activities. MAJOR ACTIVITIES AND RESPONSIBILITIES Reporting to the Senior Director, Pharmaceutical Development, the Associate Director, Drug Product Development will: • Managing external contract manufacturing organizations during all lyophilization and aseptic fill/finish d  ...View Job