Director, Analytical Development

Osanni is Designed for Sight. We are creative & agile innovators, passionate about developing breakthroughs to save eyesight. At Osanni, we are creating a uniquely different biotech company with the talent and unconventional thinking to deliver therapies to prevent and reverse blindness caused by retinal diseases.

We focus where others aren’t. Retinal diseases are multi-factorial, so we are using our energy and ingenuity to navigate our own original path to address these sight-threatening conditions. Our approach to drug development brings creativity to science through design thinking. We are committed to tackling the toughest challenges and creating fundamentally different approaches to save vision. Our belief is that if we hold patients’ eyesight and physician practices as are our North Star, it will enhance our purpose, decision making, and our impact.

We are building a highly skilled and passionate team that truly enjoys the agility course of drug development and entrepreneurs.

Job Summary

We are seeking a highly motivated Director of Analytical Development to lead and execute analytical strategies supporting our development pipeline. Reporting to the VP of CMC, this individual will play a critical role in advancing programs from the earliest stages of development into the clinic. The ideal candidate combines strong hands-on laboratory expertise with the ability to effectively develop junior analysts and manage external partners, in a fast-paced environment.

Key Responsibilities

Analytical Strategy & Execution

• Drive analytical strategy to support drug substance and drug product development across multiple programs, with phase-appropriate rigor.
• Accountable for all aspects of method design, method development, method qualification/validation, impurity identification and qualification, degradation pathway identification, shelf-life strategy, specification setting, and the overall control strategy.
• Oversee and perform hands-on analytical work at Osanni’s development lab, including troubleshooting and method optimization.
• Lead and manage CDMO analytical activities, including but not limited to method development, release testing, stability program design and testing, reference standard management, product characterization, and investigations (e.g., OOT/OOS, etc.).
• Authoring and ownership of Module 3 analytical sections, as well as the ability to provide technical input across all CMC-related sections.

Leadership & Development

• Manage and mentor at least one direct report, fostering growth and development. Scale analytical capabilities, footprint, and/or the organization as may be needed over time.
• Operate as a deeply cross-functional leader across the development organization, driving alignment, resolving tradeoffs, and providing clear technical direction across programs.

Required Skills and Background:

• MS in Analytical Chemistry or related field required, PhD strongly preferred, with 10 years of industry experience in small molecule analytical development
• Demonstrated ability to work in a fast-paced startup or small biotech environment. Multi-modality experience is strongly preferred.
• Deep hands-on expertise in HPLC and LC-MS as primary analytical platforms, complemented by working knowledge of orthogonal techniques (e.g., dissolution, GC, NMR, solid-state), with the ability to select and apply appropriate methods across development and GMP settings.
• Proven experience managing CMOs/CROs and driving outsourced analytical activities.
• Experience supporting IND-enabling activities and regulatory submissions.

What Sets the Right Candidate Apart

• A highly autonomous leader with a builder mindset who sets standards in ambiguous environments and leads with judgment rather than relying on existing playbooks.
• The ability to build and sustain strong, trust-based relationships with their employees, internal teams, and external partners.

The anticipated base pay range for this role is $210,000- $240,000 plus bonus and comprehensive benefits. Total compensation, including base salary to be offered, is determined by job-related skills, experience, and relevant education or training.

We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

We will provide an intellectually stimulating, collegial and fast-paced environment. If you are ready to be a part of designing the future of sight-saving therapeutics, then we are excited to hear from you!

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