Sr. Ppq/Tech Transfer Consultant

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.

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.
• Bachelor’s degree in engineering, life sciences, or a related technical discipline preferred.