Director, Drug Product and Analytical Development

Reporting To:
Head of Technical Operations

Location:

Remote (UK preferred) or USA

The Company
Rezera is a clinical-stage biotechnology company developing differentiated oral medicines targeting NLRP3, a key upstream driver of chronic inflammation implicated in common cardiovascular and neurologic diseases. With a wholly-owned, internally-discovered pipeline led by Phase3-ready ruvonoflast in cardiovascular disease and Phase 2-ready trabzanoflast in neurologic disease, Rezera is advancing a new generation of oral anti-inflammatory medicines designed to reach the tissues affected by disease to target inflammation at its source.

Rezera is headquartered in Boston, Massachusetts, with an R&D base in Cambridge, UK.

Why Join Rezera
This is an opportunity to shape the late-stage and commercial CMC strategy for ruvonoflast at a pivotal point in its development. The role offers substantial visibility and influence across the organization, with direct responsibility for converting a promising clinical program into a robust, regulator-ready and commercially sustainable product.

Job Summary
We are seeking a Director, Drug Product and Analytical Development to provide technical and operational leadership for late-stage drug product development, clinical supplies, manufacturing and analytical activities, with primary responsibility for supporting ruvonoflast through Phase 3, regulatory submission, launch preparation and commercial supply readiness.

The successful candidate will be an experienced, hands-on CMC leader with deep expertise in oral small-molecule drug products, analytical development, stability strategy and outsourced manufacturing. Working in a virtual or highly outsourced biotechnology environment, this individual will direct CDMOs, contract testing laboratories and specialist consultants; ensure that development and validation programs are phase-appropriate and commercially robust; and deliver high-quality CMC documentation for global regulatory submissions.

Key Responsibilities

• Own and execute the drug product and analytical CMC strategy for ruvonoflast and other small-molecule programs from late clinical development through registration, launch and lifecycle management.
• Provide technical oversight of oral solid-dose formulation, manufacturing processes, packaging and product presentation, ensuring robust control strategies and reliable, scalable supply.
• Lead external drug product development, scale-up, process optimization, technology transfer, registration and validation batch manufacture, process performance qualification and commercial readiness activities.
• Support clinical manufacturing, packaging, labelling and distribution including IRT build and validation.
• Develop and oversee integrated stability strategies and programs for drug product, including registration stability, supportive studies, in-use and packaging studies, data trending, shelf-life assignment and responses to emerging stability signals.
• Lead analytical development and lifecycle activities for drug product, including method development, qualification, validation and transfer; specifications; reference standards; release and stability testing; and ongoing method performance.
• Ensure analytical methods and controls are scientifically justified, stability-indicating, phase-appropriate and suitable for commercial quality control laboratories.
• Direct the investigation and resolution of technical issues, deviations, out-of-specification and out-of-trend results, manufacturing failures and stability excursions, ensuring sound root-cause analysis and effective CAPA.
• Author, review and approve CMC documentation, including development reports, protocols, validation reports, specifications, batch records, change controls, quality risk assessments and regulatory responses.
• Lead or contribute to relevant sections of INDs, IMPDs, NDAs/MAAs and supporting briefing packages, particularly CTD Modules 2.3 and 3 for drug product, analytical methods, validation and stability.
• Support health authority interactions, inspections and pre-approval inspection readiness by ensuring data integrity, traceability and consistency across source documentation and regulatory filings.
• Select, qualify and manage CDMOs, contract testing laboratories and consultants; establish clear scopes, governance, performance measures, budgets and timelines; and hold partners accountable for quality and delivery.
• Maintain active oversight of remote contracts through…