Director, Analytical Development
Listed on 2026-07-01
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Science
Research Scientist
Osanni Bio is a development-stage therapeutics platform, headquartered in San Francisco, California. We are creative and agile innovators, relentlessly curious about finding new ways to target the biology behind diseases with the greatest unmet need and determined to do something about it.
At the center of Osanni is its innovation engine, which is optimized for discovering new scientific insights, designing novel drug concepts, and efficiently advancing programs to a meaningful proof-of-concept. Once a program is sufficiently de-risked, it graduates into its ecosystem of affiliate companies, which are equipped with the dedicated focus, specialized talent and support necessary to scale. Osanni’s architecture marries the scientific depth and operational power of a centralized platform with the speed, agility and accountability of independent companies.
The result: an opportunity to create and deliver more transformative medicines.
We hold patients and the physicians who care for them as our North Star. It guides our purpose, sharpens our decision-making, and defines our impact. Osanni is currently advancing programs in ophthalmology, cardiology and beyond. We are building a highly skilled team, passionate about having an impact on human health. Be part of creating an organization where people enjoy their work and their colleagues, are valued for their individuality, and can't imagine working anywhere else.
Aboutthe Role
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.
WhatYou Will Do
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.
- 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.
- 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.
- 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…
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