Save application

amylyx

3 days ago

Manager, Quality Operations

Remote · Cambridge, MA Cambridge, MA

220 - quality operations

greenhouse

Match & cover letter

Create a profile to see your match and get a cover letter for this role.

Create profile and match

Source: greenhouse Verified source

Never pay or share passwords or codes with an employer. How to spot a fake job

AI TL;DR

You will oversee quality operations for drug substance manufacturing and ensure compliance with GMP and GDP standards. This role involves collaboration with internal teams and external partners to maintain product quality.

AI match

Solid listing · 60/100 against the market band on this page.

Interview prep for this job

  1. What would you ship in the first month as Manager, Quality Operations at amylyx?
  2. Which tradeoff in the description would you ask about first?
  3. How do you explain a production incident to this team?
  4. What would you measure in the first two weeks?
  5. Which part of your last project maps to this stack?

Five questions are free. The rest are Pro. See Pro

Similar roles

  • No similar roles on the board yet.

Job description

You will oversee quality operations for drug substance manufacturing and ensure compliance with GMP and GDP standards. This role involves collaboration with internal teams and external partners to maintain product quality.

Details

  • Cambridge, MA, remote work available within the US (not including Alaska and Hawaii)
  • $129,000—$145,000 USD
  • Minimum 5 years of experience with a B.S. in Pharmaceutical Sciences or 3 years with an advanced degree
  • 3 years of experience in peptide or oligonucleotide manufacturing

The work

  • Provide quality oversight of drug substance production activities
  • Review and approve validation documents and quality system records
  • Prepare and approve batch disposition packages
  • Support FDA and EMA regulatory inspections