Sr. PPQ/Tech Transfer Consultant
Eliquent Life Sciences
About Company:
Who Are We?
ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medical device, and combination product companies across therapeutic modalities, phase-based pathways, and major global markets.
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Why explore your future at ELIQUENT?
ELIQUENT Life Sciences is a trusted global consulting firm helping life sciences companies navigate regulatory complexity and bring breakthrough therapies to market. Founded by former regulators and industry experts, we offer end-to-end support in regulatory affairs, pharmacovigilance, and quality compliance. Our team is driven by a shared mission to improve global health through innovation, collaboration, and integrity. At ELIQUENT, you will be part of a purpose-led organization where your expertise contributes to meaningful impact and your growth is supported every step of the way.
About the Role:
- Support post-PPQ data analysis, data verification, and report preparation.
- Author or update PPQ protocols, reports, technical assessments, and supporting validation documentation.
- Provide on-site PPQ execution support and document issues, exceptions, and outcomes. Provide technology transfer support as assigned.
- Coordinate with MSAT and program stakeholders; detailed reporting structure to be confirmed.
Minimum Qualifications:
- Senior-level biologics or biopharmaceutical process validation experience
- 5-10+ years of experience
- Familiar with viral vector manufacturing platforms.
- Hands-on PPQ protocol development, execution support, deviation/exception assessment, data verification, statistical or technical data analysis, and final report authoring.
- Experience supporting technology transfer and manufacturing readiness in a GMP and / or CDMO environment.
- Ability to independently develop technical assessments and defensible validation documentation under aggressive timelines.
- Working knowledge of FDA process validation lifecycle expectations and risk-based decision making. xhyhwjd
- Bachelor's degree in engineering, life sciences, or a related technical discipline preferred.
Vacancy posted 2 days ago
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