Who we are:

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 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 challenge of conquering the agility course of drug development and entrepreneurship. People are our greatest asset in achieving our ambitious mission at Osanni. 

We are based in the vibrant incubator located in San Carlos, CA. 

Introduction to the Role:

Osanni is looking for a highly skilled, motivated, and creative analytical scientist to join Osanni’s Development Organization. The primary function of this senior position is to lead, develop and implement Analytical & Pharmaceutical Microbiology strategy to enable development of new intraocular products intended for clinical trials and commercialization with focus on sterile liquids and sustained-release biodegradable dosage forms. The candidate will be part of cross-functional teams providing analytical leadership on projects, working closely on a shared mission to bring new ocular therapeutics to patients.

The essential components of this position are in-depth understanding of analytical development & pharmaceutical microbiology principles, method development, validation & stability, CMC regulatory & cGMP requirements as well as strong organizational skills to enable development of products intended for clinical trials and commercialization.

Key Responsibilities:

• Collaborate with Research Associates and Scientists to understand their laboratory needs, and provide guidance and support as necessary.
• Contribute effectively towards strategic and tactical development of project plans with key emphasis on analytical aspects and phase appropriate development.
• Provide technical leadership in the development & qualification of analytical methods supporting intraocular product development.
• Independently lead analytical method development, solid state characterization, validation, release, and stability testing activities at CDMOs and in-house.
• Manage analytical development activities both internally and at contract laboratories with best practices in support of Osanni pipeline from Research to Marketing Authorization applications (US/ROW).
• Work closely with contract labs to directly oversee transfer of methods, validation, and QC testing to ensure they are executed successfully and with best practices.
• Author and review technical reports, technical data packages, and relevant sections in health authority filings (including INDs, NDAs, annual reports, and any other regulatory interactions), and contribute to regulatory filing strategy.
• Collaborate effectively within Osanni teams and outside contract laboratories with excellent communication to maintain strong relationships.
• Have excellent communication (oral and written) and interpersonal skills to be able to effectively communicate scientific conclusions and project topics with key stake holders and company leadership.
• Comprehensive knowledge of analytical & microbiology development including experience in developing testing strategies for sterile products preferably intraocular products.

 

Required Skills and Background:

• PhD in Analytical/Organic Chemistry, Pharmaceutical Sciences, or related field with 7+ years relevant industry experience; MS with 11+ years of industry experience in Pharma / Biotech industry required.
• Must be a strong scientific leader who can guide scientists with clear goals of developing analytical methods, and critically and skillfully review and assess analytical methods under development. May need to provide direction for troubleshooting various issues during method development.
• Strong knowledge of laboratory operations, equipment, and techniques related to drug discovery and development.
• Scientific creativity and curiosity with the ability to apply new technologies to complex analytical challenges.
• Extensive expertise in U/HPLC, CE, and impurity assays.
• Excellent technical writing skills and experience authoring development reports, SOPs, regulatory filings, or other documents.
• Strong written and verbal communication skills, and efficient in communicating in inter-disciplinary and cross-functional teams including third-party labs.

 

The expected base pay range for this position is $150,000 - $200,000 plus bonus and comprehensive benefits.  The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as 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!