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Manager Analytical Development
Job in
Newton, Middlesex County, Massachusetts, 02165, USA
Listed on 2026-08-14
Listing for:
RBW Consulting
Full Time
position Listed on 2026-08-14
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
We’re partnering with an innovative biotech company seeking an experienced Analytical Development leader to support a diverse portfolio of small molecule and biologics programs.
Key responsibilities include:
- Leading analytical method development, validation, and transfer activities
- Overseeing release, stability, and in-process testing through external partners
- Managing stability programs and data trending across multiple development programs
- Providing technical oversight of CDMOs and contract testing laboratories
- Supporting regulatory submissions, investigations, and quality systems activities
We’re looking for candidates with:
- Extensive analytical development experience across biologics and/or small molecules
- Strong expertise in method development, validation, and stability studies
- Experience managing external laboratories, CDMOs, or outsourced development programs
- Working knowledge of GMP, ICH, FDA, and EMA requirements
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