Manager, Quality Control and Analytical Development

Onsite Cambridge, MA

220 - quality operations

greenhouse

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Job description

Join the Quality Operations team at Amylyx in Cambridge, MA, to manage analytical development activities for pipeline products. You will oversee testing and collaborate with cross-functional teams to support the delivery of therapies to patients in need.

Details

Cambridge, MA, in-office work
$125,000—$141,000 USD
5+ years of experience in biotech/pharmaceutical industry, with at least 3 years in Quality Control/Analytical Development
Technical knowledge of analytical methods for peptides and/or oligonucleotide products

The work

Plan and manage routine release testing and stability programs at external CMOs and CTLs
Manage technology transfer of method development and validation activities
Conduct technical review and trend analysis of data for active pharmaceutical ingredients
Drive analytical investigations of OOS, deviations, and troubleshooting with CMO/CTLs