Quality Director – Head of GMP Quality – IMP Mfg Product Quality role with team – Have small molecules? Gain Oligos! Based in Bedford, Massachusetts

Reference: SWM526

Expiry Date: 24-01-2023

Categories Biotech, R & D

Salary: On Application

Job Type: Full Time

Location:
Middlesex County
United States

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Job Description

This is a good opportunity to join a company with less than 500 people, where you will have visibility and support from the senior leadership, and where you will join with your own team and your own remit.

It is also a great opportunity for someone with Small Molecules experience to work in a company developing Oligos.

This R&D organization is based in the MA area, and has their own GMP site, and I am supporting a quick hire due to promotion of the person to a more senior corporate QA position, so we are hiring for this replacement a GMP Quality Director, with experience on managing Product Quality for IMPs, both DS (inhouse) and DP (contract filling and packaging).

You will manage a small team while keeping oversight and operational responsibility for batch release, OOS, deviations, and supporting technical services with PSFs and Technical Agreements.

The company will scale up their GMP site for Ph 3 in the next 18 months, so typically, now they are releasing for Ph 1/2 trials, internationally. The company is not a virtual one so the labs and GMP site are inhouse, as is their discovery and research.

We are seeking an individual who has managed people, worked in a GMP site and has hands on experience of review of BMRs as well as CMO management from a QA / QC perspective.

 

To Apply!

To apply for this role, please contact Ivan Nash or Theo Moore on US 587 216 9302 or send a full CV to Ivan.Nash@AdvTalent.com and we will reply by return. We will support you throughout the interview and on-boarding experience.

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