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 structured project management, regular technical reviews, issue escalation and risk mitigation across multiple external works treams and geographies.
• Partner closely with Drug Substance, Quality, Regulatory, Clinical Supply, Supply Chain and Program Management colleagues to align manufacturing, testing, packaging, release and supply plans with clinical and commercial milestones.
• Proactively identify technical, quality, capacity, schedule and supply risks, develop contingencies and communicate clear recommendations to senior leadership.
• Contribute to product lifecycle strategy, including comparability, post-approval changes, continued process verification, specification evolution, cost of goods and supply resilience.

Qualifications and Experience

• PhD in pharmaceutics, pharmaceutical sciences, analytical chemistry, chemistry, chemical engineering or a related discipline, with a minimum of 10 years of relevant biotechnology or pharmaceutical industry experience; or a bachelor’s or master’s degree with at least 15 years of directly relevant experience.
• Substantial experience leading drug product development and manufacturing for oral small molecules, including late-stage development, scale-up, technology transfer, process validation and preparation for commercial manufacture.
• Demonstrated ownership of stability programs supporting Phase 3 development and global registration, with strong knowledge of stability study design, data interpretation, shelf-life justification and regulatory expectations.
• Strong analytical development experience, including stability-indicating methods, method validation and transfer, specification setting, release testing, impurity and degradation control, and management of OOS/OOT investigations.
• Experience preparing and defending CMC content for late-stage regulatory submissions, including NDA and/or MAA documentation and health authority questions.
• Thorough working knowledge of cGMP, data integrity expectations and applicable ICH guidance, Essential experience managing remote, outsourced contracts and building effective working relationships with CDMOs, contract laboratories and external technical experts.
• Experience working in a biotechnology company, particularly a small, virtual or highly outsourced environment, is strongly preferred.
• Experience supporting commercial launch, PPQ, pre-approval inspection readiness, continued process verification or post-approval lifecycle management is highly desirable.
• Proven ability to manage multiple complex work streams, budgets, timelines and external partners while maintaining scientific rigor, quality and urgency.

Leadership and Personal Characteristics

• A pragmatic, hands-on technical leader who combines strategic judgement with attention to operational detail.
• Scientifically rigorous and data-driven, with the confidence to challenge assumptions and make clear, risk-based recommendations.
• An effective influencer and negotiator who can lead external partners without direct line authority and establish accountability across organizational boundaries.
• Clear and concise communicator, able to explain complex CMC issues and their business implications to technical teams, executives and regulators.
• Highly organized and dependable, with strong ownership, sound judgement and a consistent focus on delivery.
• Collaborative, and comfortable operating in a fast-moving, resource-conscious biotechnology environment.
• Committed to quality, ethical conduct, patient safety and building systems that support sustainable commercial operations.