Our client – a growing Biopharmaceutical company – is looking to hire an Associate Director – Analytical Development.
This is a newly created, remote position.
In this role, you will provide technical and scientific leadership in analytical method development, validation, and technology transfer to support the late-phase development and commercialization of biologics, specifically monoclonal antibodies. You will oversee third-party vendors and ensure analytical strategies align with regulatory and quality requirements.
Key Responsibilities:
Lead analytical strategy and execution, ensuring robust control strategies.
Develop, optimize, validate, and transfer analytical methods, including LC/MS and bioassays (ELISA, cell-based).
Manage method transfers and tech transfers across internal teams and third-party vendors.
Review study designs, protocols, and reports to ensure compliance and efficiency.
Oversee quality events, lab investigations, and regulatory documentation.
Support regulatory filings and agency inspections as needed.
Qualifications & Experience:
MS or Ph.D. in a relevant scientific discipline with 7+ years of bio-analytical experience in biologics development.
Strong expertise in mass spectrometry (LC/MS) for product characterization and release testing.
Strong background in late-phase development and commercial biologics, and experience with monoclonal antibodies is a strong plus.
Experience with FDA regulatory requirements (EU/EMA knowledge is a plus).
Strong project management and troubleshooting skills in a fast-paced environment.
This is an excellent opportunity to contribute to a high-growth company shaping the future of biologics development.
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