Mirador is a next-generation precision medicine company focused on immunology and inflammation. The company's Mirador360 TM precision development engine leverages the latest advances in human genetics and cutting-edge data science to rapidly advance new precision medicines for patients living with chronic immune-mediated inflammatory and fibrotic diseases. Launched in 2024, Mirador has raised over $400 million from leading life sciences investors and is based in San Diego, CA.
Summary
We are seeking a motivated individual to join our CMC team and be responsible for assembling, managing, and writing the quality sections of CMC submissions and associated technical documents for biological and small molecule assets. This individual will be embedded in technical teams within the CMC department supporting our growing pipeline projects and contribute to developing clinical and commercial programs.
Responsibilities
- Manage the preparation and review of technical contributions to critical clinical and commercial programs, including INDs, IMPDs, BLAs, NDAs, MAAs, and associated questions from Regulatory Authorities, including post-approval changes.
- Assemble and/or author the necessary CMC reports from source documents such as process performance qualification protocol/ reports, method validation reports, specifications, COAs, stability protocols, stability data.
- Responsible for working with third party vendors on source documentation review and approval.
- Provide risk assessments for CMC changes, deviations, strategic mitigations plans, manufacturing site transfers, nitrosamines, PGIs, etc. while working with Regulatory so they can properly reflect the information in regulatory filings.
- Work cross-functionally with CMC, Regulatory, and QA colleagues to ensure consistency across regulatory and technical documents.
Experience and Qualifications
- Bachelor's degree in a scientific discipline required, advanced degree (Master's or PhD degree) strongly preferred.
- 8 years or more of previous biotechnology/pharmaceutical industry is required.
- Experience with quality sections (Module 3) for global regulatory submissions.
- Proficient in high quality technical writing.
- Experience with Veeva, eCTD templates, and the Microsoft suite of programs.
Skills and Abilities
- Leadership capabilities for cross functional teams with exceptional organizational and communication skills.
- Ability to work on several projects and assignments at the same time, with appropriate prioritization.
- A commitment to collaborative leadership, management, teamwork, delegation and fostering a professional culture based on trust and mutual respect in a fast-paced environment.
- Competent in reviewing, analyzing, and assembling source data to convey accuracy in the required regulatory filings.
- Ability to work well under pressure and meet time sensitive deadlines.
- Ability to work across locations and time zones.
- Highly proficient using Microsoft Word, Excel, PowerPoint, Project, SharePoint, Starting Point templates, or similar applications and systems.
The expected base pay range for this position is $170,000 - $210,000 plus bonus, equity, 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. This range may be modified in the future.
All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.
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